Immediate efficacy of auricular acupuncture combined with active exercise in the treatment of acute lumbar sprains in 10 minutes: Protocol of a randomized controlled trial

Background Acute lumbar sprain (ALS) is common musculoskeletal disorder characterized by severe low back pain and activity limitation, which significantly impacts the patient’s work and life. Immediate relief of pain and restoration of mobility in a short period of time are the main needs of patients when they visit the clinic. This study aims to evaluate the immediate efficacy of this combined treatment for ALS within 10 minutes. Methods This is a single-center, prospective, randomized clinical trial. 128 eligible patients with ALS will be randomly allocated in a 1:1 ratio to either the auricular acupuncture (AA) group or the sham auricular acupuncture (SAA) group. All patients will receive a single 10-minute treatment. The primary outcome will be the change in pain intensity after 10 minutes of treatment. The secondary outcomes include changes in pain intensity at other time points (2, 5 minutes), changes in lumbar range of motion (ROM) at different time points, blinded assessment, treatment effect expectancy scale evaluation, and treatment satisfaction scale evaluation. All participants will be included in the analysis according to the intention-to-treat principle. Discussion This is the first randomized controlled trial to assess the immediate efficacy of AA combined with active exercise for ALS. The findings of this study are expected to provide a simple and rapid treatment for ALS in clinical. Trial registration Chinese Clinical Trial Registry ChiCTR2400083740. Registered 30 April 2024.


1.Background and purpose of the study
Acute lumbar sprain (ALS) is a common musculoskeletal disorder, often caused by the abrupt overstretching of the muscles, fascia, and ligaments in the lower back due to external forces.It is characterized by severe pain and activity limitation in the lower back, which significantly impacts the patient's work and life.Therefore, quickly relieving symptoms in a short period of time is the main need of patients visiting the clinic.
According to the guidelines of the American College of Physicians, nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended as the first-line pharmacological treatment for ALS, with diclofenac being the most commonly used NSAID.A study has shown that diclofenac began to have effects at approximately 0.6 ± 0.05 hours after administration, with peak analgesia at 2.7 ± 0.24 hours.Despite the convenience of oral administration, the delayed onset of action and moderate analgesic efficacy of NSAIDs limit their clinical application to some extent.Furthermore, there is guidance suggesting that non-pharmacological therapies can be used as a priority treatment, highlighting the importance of non-pharmacological intervention studies.
Auricular acupuncture (AA), as a form of traditional acupuncture therapy, offers potential advantages in pain management.Due to its simple treatment modality and rapid onset of action, it is particularly suitable for acute pain disorders in clinical practice.A previous study has shown significant pain relief with AA for lumbar pain, but limited efficacy for lumbar mobility disorders.Exercise therapy, commonly utilized in the management of mobility disorders, has shown good efficacy for low back pain when combined with AA, significantly improving pain and function.
However, there is a lack of rigorous randomized controlled trials to support the combination of AA with active exercise in the treatment of ALS, and further studies are required.
In this study, 128 patients with ALS will be recruited as study subjects, and sham auricular acupuncture (SAA) as control to observe the immediate efficacy of AA combined with active exercise for ALS.

Study design
The study focuses on individuals with ALS, dividing them into the AA group and the SAA group.The aim is to study both intra-group (before and after treatment within each group) and inter-group comparisons (between the two groups).

Sample size
This study is a superiority trial designed to assess whether AA combined with active exercise is more effective than SAA combined with active exercise for the treatment of ALS.A previous study showed that VAS scores decreased by 4.6 ± 1.0 and 2.7 ± 1.0 after 10 minutes of acupuncture combined with exercise and sham acupuncture combined with exercise for ALS, respectively.Based on the results of this study, we predict that the change in VAS scores post-treatment will be 4.6 ± 1.0 in the AA group and 2.7 ± 1.0 in the SAA group, with α=0.025 (unilateral), β=0.1, Δ=1.3, and K=1.
The sample size calculation is based on the following formula:

Randomization metho
It was calculated that a minimum of 58 participants were needed in each group.
Taking into account the 8 percent dropout rate, we plan to recruit at least 128 participants for this study.

d
Participants will be randomly assigned to the AA group and the SAA group in a 1:1 ratio.To minimize selection bias, an independent statistician will use SPSS 28.0 (IBM, Chicago, IL, license code: f56b44b8d8e3562ad8a2) to generate random numbers.These numbers will be enclosed in opaque envelopes.Participants will choose one of these envelopes after agreeing to the principle of random allocation, which will determine their group assignment and the corresponding intervention method.

Blinding
Participants, outcome assessors, and statistical analysts will be blinded to group assignments.Although acupuncturists will be aware of the treatment allocations, they will not participate in the subsequent outcome assessment or data analysis.

Control group
The study establishes a SAA group as the control group.

Inclusion criteria
1. Meet the diagnostic criteria for ALS;

Handling of excluded and dropped cases
(1) Upon a subject's dropout, the supervising physician should inquire about the patient's reasons, record the last data, and complete the assessments that can be completed.
(2) For cases withdrawing due to adverse reactions or ineffective treatment, the supervising physician should take appropriate measures based on the actual conditions of the subjects.
(3) Fill out the "Treatment Completion Summary" and "Clinical Trial Completion Status" in the Case Report Form (CRF).
(4) All excluded or dropped cases should be analyzed for intention-to-treat at the end of the trial.
(Note: Intention-to-treat analysis (ITT) refers to including subjects in the effectiveness analysis of the group they were assigned to, regardless of whether they received the group's intended treatment.)

Case termination criteria
(1) Subjects who experience increased pain or other severe adverse reactions during the study, making it inappropriate to continue participation.
(2) Subjects who request to withdraw from the clinical study midway.

Procedures
(1) Auricular acupuncture group: Participants will be in a seated position.The acupuncturist will sterilize the skin of the healthy side AH9 with a 70% alcohol swab.
Subsequently, a disposable auricular needle will be pierced vertically into the healthy side AH9.After needle insertion, moderate pressure will be applied to elicit the "de qi" sensation.Upon achieving "de qi", participants will be asked to stand.The acupuncturist will stand behind the participant and support the participant's waist.
Then, the participant will be guided through moderate exercises, including forward bending, backward stretching, lateral bending, and rotation, all performed within the limits of their pain tolerance.The range and speed of these movements will gradually increase as the pain decreases.
(2) Sham auricular acupuncture group: This group will receive treatment with a placebo needle of the same shape which lacks a needle body and does not penetrate the skin but is merely taped at the acupoint.The treatment operation is the same as the AA group.
Participants in both groups will receive a single treatment session, with a 10-minute auricular needle retention time.

Remedial pain management
If patients experience intolerable lower back pain that does not improve post-treatment, they will take the non-prescription NSAID pain reliever ibuprofen.
The dosage, time of administration, and the duration until pain relief are recorded.

Observation period
Baseline assessments will be performed before enrollment, and pain intensity and ROM evaluations will be conducted 2, 5, and 10 minutes post-treatment.

General items
Patient's name, gender, age, diagnosis, and course of illness will be recorded in the patient CRF.
(3) Basic medical history and routine physical examination.These indicators will be recorded at the time of enrollment.

Diagnostic indicators
Chief complaints and clinical manifestations, medical history, physical examination; auxiliary examinations such as lumbar spine X-rays, CT, MRI will be conducted for disease diagnosis by the primary physician.

Primary outcome
The primary outcome will be the change in pain intensity from baseline to 10 minutes after treatment as measured using VAS scores.

Secondary outcomes
(1) Changes in pain intensity at 2 and 5 minutes after treatment will also be measured using VAS scores.
(2) Lumbar range of motion (ROM) will be assessed at baseline, 2, 5, and 10 minutes during treatment.Participants will be instructed to stand with their feet slightly apart, shoulder width apart, and their body relaxed.Measurements will be taken for forward flexion, backward extension, right lateral flexion, and left lateral flexion in order.
(3) Patient expectations of treatment outcomes will be assessed at baseline using the efficacy expectations scale.
(4) The success of the blinding will be assessed at the end of treatment using a blinded questionnaire.ment regimens, including the time of occurrence, severity, measures taken, and outcomes, to assess their relevance to the treatment.

Safety assessment
Statistically compare adverse events that occur under different treatment regimens in this study and evaluate the safety of each regimen.Thoroughly document the time of occurrence, symptoms, severity, measures taken, and resolution of adverse events.In cases of adverse events, clinical physicians will decide whether to discontinue the trial based on the patient's condition, with severe cases being reported to the Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine within 24 hours, while also making the appropriate records.

Visual analogue scale
Use a 10cm VAS scale with a moving scale between 0 and 10 on the front and a number from 0 to 10 on the back, with 0 being no pain and 10 being the most painful.
Please state your pain level according to the following scale.

Range of motion
In this study, lumbar range of motion will be measured using an angulometer as follows: The patient stands upright with feet shoulder-width apart and muscles relaxed.For flexion and extension of the lumbar spine, the center of the goniometer is fixed at the lateral line of the body, transverse to the 5th lumbar spine.For lumbar lateral flexion, the center of the goniometer is aligned with the 5th lumbar spinous process.The (2) Measurement Bias: When measuring outcomes between AA and SAA groups, especially when it's known which group is which, measurement observations are likely to differ due to subjective reasons, leading to judgment biases, particularly in non-blinded observations.
(3) Confounding Bias: Confounding bias mainly appears during the result analysis phase, where two factors may be intertwined or affect each other, possibly attributing the cause of a result incorrectly due to other co-existing factors (confounders) that could produce the same outcome, leading to exaggerated or minimized conclusions.

Control
(1) Choice of Study Design: This study uses a randomized control design, which is the most effective way to avoid selection bias.
(2) Strict Selection of Subjects: Strict inclusion criteria are one of the important methods to control bias.Establishing clear inclusion and exclusion criteria restricts study subjects to a specific range, reducing differences and facilitating objective conclusions about observed factors.
(3) Blinded Measurement and Judgment: Blinding is the most effective way to avoid measurement biases by researchers and subjects.If the researcher knows which treatment a participant is receiving, they might unconsciously favor reporting improvements in the treatment group.Although researchers may be honest, they tend to hope for favorable outcomes, thus the best way to avoid this bias is through blinded measurements and judgments.Although acupuncturists will be aware of the treatment allocations, they will not participate in the subsequent outcome assessment or data analysis.Blinded statistical analysis during the data summarization stage to ensure the reliability of the study results.

Research training
To ensure the smooth conduct of the study, a specialized clinical training session will be held before the start of the study.All researchers will receive uniform training on the implementation plan and detailed operational training to familiarize and master the research process and specific implementation rules, enhancing internal consistency among researchers and between observers, and ensuring the reliability of research conclusions.

Measures to improve participant compliance
To achieve better compliance, ensuring that the number of cases analyzed at the end is no less than 80% of those entering the study, the following measures will be used: adhere to the principle of voluntariness, sign informed consent forms with participants and their families; improve and maintain good compliance through medical quality, clinic environment, and medical costs, encouraging participants to adhere to the treatment during the study; establish good doctor-patient relationships, explain the condition, treatment purposes and necessity in detail, and obtain consent and cooperation from participants.Communicate with patients before starting treatment, observe the efficacy after one treatment session, and if the subsequent relief is not significant, offer two additional acupuncture treatments free of charge.At the end of the treatment, review and perfect the relevant records together with the participants.

Quality control and assurance system
The project leader will supervise and inspect the entire study process, ensuring all study data records, reports, and case report form entries are true, accurate, and complete, and consistent with the original data.

Data management
Researchers are responsible for data management of the project, with supervision by

Safety data set
Safety Data Set (SS): All participants who completed treatment after randomization.

Participant handling
Summarize the number of participants who started, completed, and discontinued the study.Additionally, summarize the reasons for discontinuation.

Efficacy evaluation
All efficacy evaluation data will be summarized separately according to the FAS and PPS sets, with the FAS set as the primary analysis method.

Statistical analysis methods
This study utilizes SPSS 28.0 for the analysis of clinical data.Continuous variables with normal distribution will be expressed as mean ± SD and continuous variables with non-normal distribution will be reported as median and interquartile range (IQR).
For analyzing demographic data, continuous variables will be analyzed using the independent samples t-test or the Wilcoxon rank sum test depending on whether or not they conform to a normal distribution.Categorical variables will be analyzed using χ 2 test or Fisher's exact test.All significant demographic differences will be included as covariates in subsequent efficacy analyzes.The primary outcome indicator will be analyzed using analysis of covariance with baseline pain levels as a life-threatening situations, resulting in hospitalization, prolonging hospital stay, long-term or significant functional impairment/disability, or requiring medical or surgical treatment to prevent serious consequences.
(2) Handling of Adverse Events: AEs occurring during the study will be summarized by total number, system organ class (SOC), or other terms, summarizing at least once occurring event incidence.AEs will also be summarized by severity and relatedness to acupuncture.SAEs leading to study discontinuation will also be summarized.
For each count and incidence, each participant is counted only once regardless of the number of occurrences.When summarizing adverse events, missing severity ratings or causality assessments will be classified as "serious" and "definitely related."All AEs will be presented in lists, including SAEs leading to study discontinuation due to acupuncture, and events leading to fatal outcomes.Missing values and incomplete dates in the lists will be displayed consistent with original records.
12 Ethical principles

Ethical review
This study project must be reviewed and approved by the institutional ethics committee before the clinical study can commence.

Benefits and risks
Participants in this study project will be informed about the content of the clinical study, including its purpose, methods, and procedures such as treatment methods, grouping, and testing items.During the study, participants will receive AA or SAA and undergo free examinations related to the project.Adverse events, such as fainting, pain at the acupuncture site, bleeding, hematoma, or infection during acupuncture, will be recorded and properly addressed until fully resolved.
Participants' personal data must be kept confidential.Participation in the clinical study is completely voluntary, and participants can withdraw at any stage without facing discrimination or retaliation, and their medical treatment and rights will not be affected.If any damage related to the clinical study occurs, participants will be entitled to appropriate compensation.

Informed consent
(1) Researchers must familiarize themselves with and verify the comprehensiveness and compliance of the informed consent form (including ethical committee approval and adherence to the rights and duties of participants as stipulated in the Declaration of Helsinki) before discussing with participants and their families.Any amendments to written materials or the informed consent form must be approved by the ethics committee before re-obtaining informed consent from participants.
(2) The informed consent document should be explained to participants in clear and understandable language, including the purpose of the study, procedures, duration, examinations, expected benefits, and potential risks.Efforts should be made to avoid technical jargon to ensure participants fully understand the consent content.
(3) Participation in the study is voluntary, and participants have the right to withdraw at any time without discrimination or retaliation, and their medical treatment and rights will not be affected.proceed.If the participant and their representative are illiterate, a witness must be present, and after a detailed explanation and oral consent, the witness must sign and date the consent form.Researchers must rigorously implement the informed consent process to ensure that participants fully understand the study requirements and cooperate with the research.

Summary and data preservation
Upon completion of the research project, a summary of the data will be made, and original materials such as the research protocol, informed consent forms, ethical committee approvals, ethical committee member list, completed and signed case report forms with dates, original serious adverse event reports, CRF forms, operation manuals, researcher's signature stamps, and all related original materials will be archived by the research team.
criteria ALS diagnosis is based on the "Clinical Diagnosis and Treatment Guidelines: Orthopedics" published by the Chinese Medical Association, which includes: 1. Definite trauma history and low back pain immediately after the injury; 2. Spasm of the lumbar muscles and limitation of movement; 3. Localized tenderness at the injury site; 4. No obvious abnormalities on imaging.

( 3 )
Patients who are uncooperative and non-compliant with treatment, despite repeated explanations by the clinician.(4) Researchers should record in detail the reasons and timing of withdrawal from the study; cases that have surpassed half of the treatment duration should be included in the efficacy analysis.Auricular point selection is based on prior studies and traditional auriculotherapy, which involves selecting auricular regions that correspond to body anatomical parts.The Lumbosacral Vertebrae (AH9) (Located on the body of the antihelix posterior to the Abdomen) will be selected.The auricular point will be positioned according to the World Federation of Acupuncture Societies Standard Acupoint Positioning, as depicted in Fig 1.

( 2 )
Sham auricular needles: Same Seirin Corporation single-use sterile microneedles, registration number as above.Placebo needles look identical to real needles but lack a needle body and do not penetrate the skin, see Figure2B.
Fig 3 Lumbar motion measurement