Effects of an Artificial Intelligence–Assisted Health Program on Workers With Neck/Shoulder Pain/Stiffness and Low Back Pain: Randomized Controlled Trial

Background Musculoskeletal symptoms such as neck and shoulder pain/stiffness and low back pain are common health problems in the working population. They are the leading causes of presenteeism (employees being physically present at work but unable to be fully engaged). Recently, digital interventions have begun to be used to manage health but their effectiveness has not yet been fully verified, and adherence to such programs is always a problem. Objective This study aimed to evaluate the improvements in musculoskeletal symptoms in workers with neck/shoulder stiffness/pain and low back pain after the use of an exercise-based artificial intelligence (AI)–assisted interactive health promotion system that operates through a mobile messaging app (the AI-assisted health program). We expected that this program would support participants’ adherence to exercises. Methods We conducted a two-armed, randomized, controlled, and unblinded trial in workers with either neck/shoulder stiffness/pain or low back pain or both. We recruited participants with these symptoms through email notifications. The intervention group received the AI-assisted health program, in which the chatbot sent messages to users with the exercise instructions at a fixed time every day through the smartphone’s chatting app (LINE) for 12 weeks. The program was fully automated. The control group continued with their usual care routines. We assessed the subjective severity of the neck and shoulder pain/stiffness and low back pain of the participants by using a scoring scale of 1 to 5 for both the intervention group and the control group at baseline and after 12 weeks of intervention by using a web-based form. We used a logistic regression model to calculate the odds ratios (ORs) of the intervention group to achieve to reduce pain scores with those of the control group, and the ORs of the subjective assessment of the improvement of the symptoms compared to the intervention and control groups, which were performed using Stata software (version 16, StataCorp LLC). Results We analyzed 48 participants in the intervention group and 46 participants in the control group. The adherence rate was 92% (44/48) during the intervention. The participants in the intervention group showed significant improvements in the severity of the neck/shoulder pain/stiffness and low back pain compared to those in the control group (OR 6.36, 95% CI 2.57-15.73; P<.001). Based on the subjective assessment of the improvement of the pain/stiffness at 12 weeks, 36 (75%) out of 48 participants in the intervention group and 3 (7%) out of 46 participants in the control group showed improvements (improved, slightly improved) (OR 43.00, 95% CI 11.25-164.28; P<.001). Conclusions This study shows that the short exercises provided by the AI-assisted health program improved both neck/shoulder pain/stiffness and low back pain in 12 weeks. Further studies are needed to identify the elements contributing to the successful outcome of the AI-assisted health program. Trial Registration University hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) 000033894; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038307.


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the title, "Using Chatbot Through a Mobile Messaging App".
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

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Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No. We did not mention it in the Title as we did not use any non-web-based components.

1a-iii) Primary condition or target group in the title
Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 選択を解除 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Title, "Workers with Neck/Shoulder Pain/Stiffness and Low Back Pain".

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Methods of the Abstract: "the AI-assisted health program, in which the chatbot sent messages to users with the exercise instructions at a fixed time every day through the smart phone's chatting app (LINE) for 12 weeks." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 選択を解除 Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Abstract: "The program is fully automated." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 選択を解除 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Methods of the Abstract: "We recruited participants with these symptoms through email notifications.", and "We assessed the subjective severity of the neck and shoulder pain/stiffness and low back pain of participants using a scoring scale of 1 to 5 for both the intervention and the control group at baseline and after 12 weeks of intervention using an online form." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Results of the Abstract: "We analyzed 48 participants in the intervention group and 46 in the control group. The adherence rate was 93.6% (44/47) during the intervention. The participants in the intervention group showed significant improvements in the severity of the neck/shoulder pain/stiffness and low back pain compared to those in the control group (OR 6.36, P <.001). Based on the subjective assessment of the improvement of the pain/stiffness at 12 weeks, 36 out of 48 participants (75%) in the intervention group and 3 out of 46 (7%) in the control group had improved (improved, slightly improved) (OR 43.00, P <.001)." Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not obtain negative results in this study.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5)

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Introduction: "One problem with exercise therapy is the low level of adherence to the prescribed exercises. Two systematic reviews reported that up to 70% of participants did not adhere to prescribed exercises [22,23].", "In Japan, the medical system has not been able to provide sufficient services for such conditions. Some enthusiastic medical professionals, preventive medical services, and occupational health services provide care for people with functional impairments, such as musculoskeletal symptoms. In most other situations, patients need to look for ways to improve their symptoms on their own.", "Besides, 65% percent of smartphone apps that perform selfmonitoring and self-managing of chronic pain have been developed without the involvement of experts and proper supporting evidence [39].", "Conversely, it has also been suggested that digital interventions may have possibilities to improve adherence in the target population [26].", and "The aim of this study was to improve neck/shoulder pain/stiffness and low back pain of workers who experienced from those symptoms by continuing to do exercises that included stretching and mindfulness. As a measure of encouraging them to continue the exercises, we provided them with secaide Ver.0.9 [44], an artificial intelligence (AI)-assisted interactive health promotion system using a mobile messaging app (the AIassisted health program)." 2a-ii) Scientific background, rationale: What is known about the (type of) system Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator.

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Introduction: "Several studies have reported methods to minimize the discomfort from such symptoms-a combination of exercises and psychological approaches seems effective for patients with musculoskeletal symptoms. Moderate to strong evidence suggests that exercise therapy is effective in relieving pain and improving function in musculoskeletal disease.(omitted) "Two systematic reviews reported that up to 70% of participants did not adhere to prescribed exercises. (omitted)", and "Three systematic reviews that included a plethora of studies with digital interventions, for example, mobile phone apps, websites, and web-based software have been performed involving musculoskeletal symptoms. (omitted) Besides, 65% percent of smartphone apps that perform self-monitoring and self-managing of chronic pain have been developed without the involvement of experts and proper supporting evidence. (omitted) Some studies including digital health interventions have shown enhanced self-management and adherence to medication in patients with asthma, chronic obstructive pulmonary disease, hypertension, and diabetes." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Introduction: "The aim of this study was to improve neck/shoulder pain/stiffness and low back pain of workers who experienced from those symptoms by continuing to do exercises that included stretching and mindfulness. As a measure of encouraging them to continue the exercises, we provided them with an artificial intelligence (AI)-assisted interactive health promotion system using a mobile messaging app (secaide [44], abbreviated as 'AI-assisted health service'). We hypothesized that this digital intervention would support participants to continue exercising and enhance their adherence to the exercises, resulting in greater improvement in symptoms. To the best our knowledge, this is the first study to use a chatbot as a health care support measure through a messaging app to improve musculoskeletal symptoms for workers." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Design and Randomization of the Methods: "This study was a two-armed, randomized, controlled, and unblinded trial on workers with neck/shoulder pain/stiffness and/or low back pain. We set the intervention and control groups and the participants of the intervention group used the AI-assisted health program for 12 weeks and those of the control group continued their regular exercise routine at workplace.", and "with a 1:1 allocation ratio".
Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not change the methods after the trial started.
subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

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Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We have not experienced any bug fixes, downtimes, and content changes.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Population of the Methods: "We targeted those who answered "frequently" or "almost always" in either of the following questions in the survey: 1. How often do you have a stiff neck and/or shoulders? 1) Almost never, 2) Occasionally, 3) Frequently, 4) Almost always, 2. How often do you have low back pain? 1) Almost never, 2) Occasionally, 3) Frequently, 4) Almost always", and "The inclusion criteria were as follows: employees 1) aged 20 to 64 years, 2) who had their own cell phones and the apps could be installed on the phones, and 3) who understood the purpose and agreed to the publishing of the contents and results of the study. The exclusion criteria were as follows: employees who 1) disagreed with the study, 2) were pregnant or may have been pregnant, 3) had cardiopulmonary diseases, 4) participated in other clinical trials, and 5) had any other obvious disabilities or exercise restrictions."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

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Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not clarify the computer/Internet literacy in this study, because the participants were all workers who used computers in their daily work and used their own smartphone in a daily basis. We just have included in the inclusion criteria that "employees who had their own cell phones and the apps could be installed on the phones." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

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Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Population of the Methods: "We conducted this study in a company that develops, designs, and manufactures precision electronic components, which has approximately 2200 employees.", "The occupational health staff of the company recruited employees with remarkable musculoskeletal symptoms, either or both neck/shoulder stiffness and low back pain.", and "They recruited applicants by email notification between 3 and 14 September 2018."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

4b) Settings and locations where the data were collected
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Study Design, Intervention of the Methods: "We provided an explanatory document regarding the study to the applicants and obtained informed consent.", and "We held an initial training session for the applicants to explain the purpose of the study and obtain informed consent." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Outcomes of the Methods: "All participants answered the questions through an online form."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Outcomes of the Methods: "All participants answered the questions through an online form."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results)

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Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No. It is not described in the manuscript. The occupational health staff of the targeted company told the participants that the interventional study was collaborated with the staffs of the university of Tokyo. We are not sure if it affected or biases the results.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We mentioned in the Intervention of the Methods, and in the Conflicts of Interest: "The program we used in this study was named secaide Ver.0.9, which was patented and have been created and developed since June 2017 by Travoss Co., Ltd., and an orthopedist who specialized musculoskeletal disorder.", and "Ko Matsudaira is a shareholder/adviser of Trunk Solution Co., Ltd., who has a patent for the AI-assisted health program using in this study".

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We mentioned in the Intervention of the Methods: "The program we used in this study was named secaide Ver.0.9, which was patented and have been created and developed since June 2017 by Travoss Co., Ltd., and an orthopedist who specialized musculoskeletal disorder. Until we performed this interventional study, the program had not been used or evaluated previously."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

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Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The system we used in this study were not revised and updated during the intervention.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

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Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not adopt and grasp quality assurance methods for the AI-assisted health program.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We provided some screenshots of the screen of the AI-assisted health system in the Figure  1. The system is commercially available. We also provided the reviewers introduction videos of the AI-assisted health system. The flowcharts of the algorithms used in the system has archived at Japan Patent Office.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study In the Reference list of the manuscript, we showed the website of the AI-assisted health program, https://www.secaide.me/. In case the website disappears, an archived page is https://webcache.googleusercontent.com/search? q=cache:QTdPBshGJWQJ:https://www.secaide.me/+&cd=1&hl=ja&ct=clnk&gl=us. If you apply to use the AI-assisted health program, you can get access to the program because it is commercial.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

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Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Intervention of the Methods: "We also explained to the participants of the intervention group how to install and use the AI-assisted health program on their cell phones to inform them a QR code and a passcode to access the program on September 26 and 27, 2018." If you apply to use the AI-assisted health program, you can get access to the program because it is commercial. Users were normally charged the fee. In this study, they were not charged. We also provided the reviewers introduction videos of the AI-assisted health system.
subitem not at all important

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Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Intervention of the Methods: "The AI-assisted chatbot was programmed to send the users messages with the exercise instructions and some tips on what they can do in their daily lives to improve those symptoms. The messages were sent every day at a fixed time through LINE. The notification time could be changed by the users to a time convenient for them. The participants could finish their exercise within 1 minute each day. The program is interactive and the participants can respond to the messages using a simple selection list; the chatbot offers them tailored replies depending on their responses.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Intervention of the Methods: "The messages were sent every day at a fixed time through LINE. The notification time could be changed by the users to a time convenient for them. The participants could finish their exercise within 1 minute each day."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Intervention of the Methods: "we did not provide any human support".

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

選択を解除
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. Although we didn't send specific reminders in addition to the program, we considered the messages that were sent from the chatbot every day at a fixed time also had reminder function. We mentioned it in the Discussion: "The chatbot sent a message with the exercise instructions and a corresponding illustration at a fixed time every single day, which also functioned as a reminder feature that sent instructions at a fixed time each day." subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.

選択を解除
Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not perform any co-interventions such as training and support.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Outcomes of the Methods: "In this study, we set two types of outcomes. The first was a subjective assessment of the degree of pain on a scale of 1 to 5; this included subjective ratings of the neck/shoulder stiffness/pain and low back pain at baseline and after 12 weeks. A score of 4 or more was defined as severe pain. The second was a subjective assessment of whether there was an improvement. The participants were asked to subjectively rate whether their pain had improved after 12 weeks; they chose from the following options: improved, slightly improved, unchanged, slightly worse, and worse. Those who responded that their pain had improved or slightly improved were defined as the group that showed subjective improvement. All participants answered the questions through an online form." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].

選択を解除
Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
We did not validate the questionnaires for online use and apply CHERRIES items.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Yes. We described it in the Adherence to the Program of the Methods: "We counted the number of participants who continued to access and reply the chatbot's messages at least once every 3 days and excluded the participants who did not access and reply for three weeks in a row." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
選択を解除 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 6a-iii?

Copy and paste relevant sections from manuscript text
The owner of the program, Travoss, collected feedbacks from the participants of the program. If they had technical problems, they could ask the inquiry service of the program.

Does your paper address CONSORT subitem 6b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not change trial outcomes.

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size. 選択を解除 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This intervention was performed as an occupational health activity at a company and all employees who wanted to participate in the study were accepted unless they did not meet the inclusion criteria or they violated the exclusion criteria. Therefore, we did not calculate the sample size or power, nonetheless, the results obtained showed statistically significant differences.

Does your paper address CONSORT subitem 7b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not perform any analyses during the intervention Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Randomization of the Methods: "After we confirmed that the applicants met all the inclusion criteria and did not violate any of the exclusion criteria, all 121 participants were randomized to the two groups by generating random numbers on a computer and stratified by 10-year age groups and separated them by the age group with a 1:1 allocation ratio." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We used stratified randomization.
Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Randomization of the Methods: "all 121 participants were randomized to the two groups by generating random numbers on a computer and stratified by 10-year age groups and separated them by the age group with a 1:1 allocation ratio." 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study One of the authors, Dr. Oka generated the random allocation sequence. We also described it in the Study Population of the Methods and the Results: "The occupational health staff of the company recruited employees with remarkable musculoskeletal symptoms" and "we randomly assigned them to an intervention group (n=61) and control group (n=60)".

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Study Design of the Methods: "This study was a two-armed, randomized, controlled, and unblinded trial on workers with neck/shoulder pain/stiffness and/or low back pain. We set the intervention and control groups ".
subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Limitation: "we did not reveal to the intervention group that they were the intervention group".
Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Intervention of the Methods: "The control group continued with their regular exercise routine, which included exercising for about 3 minutes during the break time provided by the company every day to prevent stiff shoulders and back pain. We also allowed the control group to use the AI-assisted health program after the 12-week intervention." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Statistical Analysis of the Methods: "A linear regression analysis was used to compare the intervention and control groups for subjective pain scores after the program. The odds ratios (OR) of the intervention group to achieve a subjective pain score of less than 3 compared with those of the control group was estimated using the logistic regression model. In addition, the OR of the subjective improvement of the symptoms compared to the intervention and control groups was estimated using the logistic regression model. All analyses were performed using Stata software (version 16, StataCorp LLC, TX, USA)."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We analyzed the data with 48 participants in the intervention group and 46 in the control. We had recruited 61 for intervention group and 60 for control group, but we lost 13, and 14 participants, respectively, for each before starting the intervention and we did not collect baseline information except for eligibility. Therefore, we were obliged to perform the study for only 48 participants in the intervention group and 46 in the control.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No. We did not perform additional analyses, such as subgroup analyses and adjusted analyses.

X26-i) Comment on ethics committee approval
選択を解除 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Design if the Methods, "This trial was conducted with the approval of the ethics committee of the University of Tokyo Hospital (ID: 12035) and the ethical review of the target company. The trial was registered at UMIN (ID: 000033894)."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Design and Intervention of the Methods: "We provided an explanatory document regarding the study to the applicants and obtained informed consent.", and "We held an initial training session for the applicants to explain the purpose of the study and obtain informed consent." subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We mentioned it in the informed consent document.
13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Population of the Results: "After we confirmed the eligibility of 121 applicants who wished to participate in the study, we randomly assigned them to an intervention group (n=61) and control group (n=60), because we had to notify the schedule of the initial session during their working hours to the participants. Unfortunately, 13 and 14 allotted in the intervention and control group, respectively, could not participate in the session or answer the baseline survey. Therefore, the intervention started with 48 and 46 participants in the intervention and control groups, respectively." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Population of the Results: "Unfortunately, 13 and 14 allotted in the intervention and control group, respectively, could not participate in the session or answer the baseline survey. Therefore, the intervention started with 48 and 46 participants in the intervention and control groups, respectively." We also described in the CONSORT flow diagram.
subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it as the Adherence to the Program of the Results: "Of the 48 participants in the intervention group, 47 started the AI-assisted health program and 44 continued the exercise for the entire intervention period. The adherence rate was 93.6% (44/47) in the study." Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Study Population and Study Design of the Methods, "They recruited applicants by email notification between 3 and 14 September 2018.", "the participants of the intervention group used the AI-assisted health program for 12 weeks", and "We assessed the subjective severity of the neck and shoulder pain/stiffness and low back pain in both the intervention and control groups at baseline and 12 weeks immediately after the intervention.". 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 選択を解除 Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We have not experienced any critical secular events during the intervention Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There was no interruption or discontinuance during the intervention.
subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described it in the Table 1, Baseline characteristics of participants.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

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Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described age and gender in the Table 1. We also described computer/Internet literacy in the Discussion: "They were usually engaged in jobs that required the use of computers and were accustomed to using smartphones on a daily basis. In other words, they had high computer/internet literacy." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

選択を解除
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We described all denominators in the manuscript, the figures, and tables.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

選択を解除
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We performed intention to treat analyses for 48 participants in the intervention group and 46 in the control that we could collect data of the baseline survey.
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described outcomes with 95% confidence interval in the Outcomes of the Results: "We performed logistic regression analyses to evaluate the differences in symptoms (neck/shoulder, back) between the baseline and at 12 weeks after adjusting for age and sex.; the result was −1.12 (95% CI −1.53 to −0.70, P<.001) ( Table 3). We also examined the OR of the outcomes (Table 3). The OR of the worst pain score at 12 weeks between the intervention and control groups was 6.36 (95%CI 2.57 to 15.73, P<.001). The OR of the subjective improvement in symptoms at 12 weeks was 43.00 (95%CI 11.25 to 164.28, P<.001)." subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it as the Adherence to the Program of the Results: "Of the 48 participants in the intervention group, 47 started the AI-assisted health program and 44 continued the exercise for the entire intervention period. The adherence rate was 93.6% (44/47) in the study." Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not use binary outcomes for a questionnaire. However, we analyzed the outcomes by dividing the answers into two categories depending on whether symptoms were severe (a score of 4 or more) or not (a score of 3 or less) at 12 weeks. Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not perform any other analyses such as subgroup analyses and adjusted analyses.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not perform a subgroup analysis of comparing only users.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not have any or unintended effects.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not have specific problems during the innervation.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

Does your paper address subitem 22-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We described it in the Discussion: "This RCT showed that the 12-week use of an AI-assisted health program that provides one short exercise routine per day significantly improved (1) subjective symptoms of both neck and shoulder pain/stiffness and low back pain after 12 weeks compared to those at baseline, and (2) the subjective assessment of improvement following the 12-week intervention in the intervention group compared to the control group. In this study, the intervention group showed a high adherence of 93.6% (44/47) for the whole intervention period as we hypothesized that this digital intervention would support participants to continue exercising and enhance their adherence to the exercises, resulting in greater improvement in symptoms." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

22-ii) Highlight unanswered new questions, suggest future research
We stated in the Discussion: "We are not sure which elements of this intervention, including the exercises themselves, were clearly effective."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

選択を解除
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We stated it in the Limitation: "Fourth, this study was unblinded because of the characteristics of the intervention. The influence of the Hawthorne effect should be considered. Although we also provided the AI-assisted health program to the control group after completing the intervention for the intervention group and we did not reveal to the intervention group that they were the intervention group, it cannot be denied that the population of the intervention group could infer that they had been selected and should be able to improve because they were doing the exercises every day." 21) Generalisability (external validity, applicability) of the trial findings

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 選択を解除 Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We stated it in the Discussion: "Although we used a specific program in this study, apps or Internet services with similar functions, such as sending easy and simple instructions every day at a fixed time, may be effective in relieving musculoskeletal symptoms."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The Ai-assisted health program was fully automated and we did not provide any additional human support except for inquiries about changes in their physical condition and the technical problems during the intervention.
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We mentioned in the Registration of the Abstract: " Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study All the protocol of this study were written on the manuscript.

25)
Sources of funding and other support (such as supply of drugs), role of funders

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We wrote it in the Funding information of the Acknowledgements: "This study was supported by a grant from the Ministry of Health, Labor, and Welfare (No. H30-rodo-ippan-008) and the 2018 Japan Full Happ Survey Research (Public Interest Incorporated Foundation Japan Small and Medium Enterprise Welfare Business Foundation). The funding agencies had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript." X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

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About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. We wrote it in the Conflicts of Interest: "The authors declare the following potential conflicts of interest: Ko Matsudaira is a shareholder/adviser of Trunk Solution Co., Ltd., who has a patent for the AI-assisted health program using in this study and received the following support: a research grant from the Ministry of Health, Labor and Welfare for the submitted work; grant support from Sumitomo Dainippon Pharma Co., Ltd., and Okamura Corporation; grant support, including lecture fees from AYUMI Pharmaceutical Corporation, Nippon Zoki Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Astellas Pharma Inc., TOTO LTD., and Eisai Co., Ltd.; lecture fees from Pfizer Japan Inc., Hisamitsu Pharmaceutical Co., Inc., Janssen Pharmaceutical K.K., Kaken Pharmaceutical Co., LTD., and Teijin Pharma Limited; and lecture fees and advisory fees from