Abstract
Background and aims
Multimodal rehabilitation (MMR) programmes, including, physical training, educational and psychological interventions by an interdisciplinary team are found to be more successful for patients with disabling chronic pain compared with less comprehensive treatments. MMR programmes are based on the biopsychosocial model and the goal is usually to improve function, quality of life and facilitate and enable return to work. As pain clinics traditionally offer conventional medical pain treatment, there is limited knowledge about MMR given in this context. The aim of our study was to describe characteristics of patients with chronic pain, treated with a MMR programme at a conventional pain clinic, to evaluate patient-reported outcome measures (PROM) from start to one year after, and to study possibly associated factors for the improvement of health-related quality of life after one year.
Methods
A prospective, observational study with a one-year follow-up was performed.
Subjects
A total of 42 individuals (38 females, age 44.0 ± 12.3 years and 4 men age 40 ± 8.5 years) with different pain diagnoses were included. After a team assessment, the patients began a programme that lasted about three months. The MMR programme contained coordinated, individually adapted treatments administered individually or in groups, and was based on cognitive behavioural principles. Questionnaires regarding health-related quality of life (HRQoL) (EQ-5D), insomnia (ISI), mental health (HADS), painrelated disability (PDI), kinesiophobia (TSK), current pain intensity (VAS) and sense of coherence (SOC) were used at the start of the MMR and at follow-up. Demographic data were collected from the patient records.
Results
The PROM at baseline showed substantial pain problems with low HRQoL (EQ-5D index of 0.1 ± 0.282, and EQ VAS of 32.67 ± 20.1), moderate insomnia (ISI 18.95 ± 6.7), doubtful cases of depression and anxiety (HADS-depression 9.35 ± 4.1 and HADS-anxiety 9.78 ± 3.95), presence of pain-related disability (PDI 39.48 ±12.64), kinesiophobia (TSK 40.8 ± 9.8), as well as moderate current pain (VAS 61.31 ± 20.4). The sense of coherence was weak (SOC of 51.37 ± 14). At one-year follow-up, significant (p ≥ 0.05) improvement occurred on the EQ-5D index, EQ VAS, ISI, PDI and TSK. In the logistic regression analysis, no significant associations could be identified.
Conclusions
MMR for patients with complex pain problems can be a successful treatment alternative at conventional pain clinics.
Implications
Since access to rehabilitation clinics in Sweden may be limited, the availability of MMR can increase by providing this type of intervention in pain clinics. Increased knowledge of MMR in different settings can also contribute to increased understanding and collaboration between pain clinics and rehabilitation units.
1 Introduction
Chronic pain is a complex condition that causes large problems for the individual with consequences that affect the level of activity and quality of life [1,2]. The consequences for society are related to increased medical costs and productivity losses [3,4]. Chronic pain is not a nociception of prolonged duration, but a unique, individualised experience, consisting of dynamic interactions of physiological, psychological and social factors [5].
The patients’ suffering includes not only pain, but also often concentration difficulties, poor social and emotional function, disability as well as financial difficulties [6]. Comorbid conditions, such as anxiety and depression that might aggravate pain and the situation are common [7]. In addition, fatigue and insomnia are commonly described problems, which further contribute to a deteriorated status [6,8,9,10].
Due to the complexity of chronic pain, there is no single easy solution. The biopsychosocial model recommends that the elements for understanding and treating chronic pain include consideration of somatic, psychological, environmental and personality aspects [5]. Multimodal rehabilitation (MMR) programmes with a cognitive approach are advocated (different interventions by different professionals coordinated according to the patients’ needs) as this can respond to the requirements of the biopsychosocial model. Evidence favours MMR compared to standard medical treatment [11,12]. Still, giving support to patients with chronic pain towards diminished symptoms, better quality of life and improved function is challenging. However, questions remain about the constitution of the often heterogeneous groups of studied patients, the treatment components and the organisational conditions leading to successful outcome [11,13].
Several studies of MMR programmes have been carried out at pain rehabilitation clinics in Sweden [14,15]. However, patients with complex pain problems are also found in other specialised pain clinics. These conventional pain clinics operate from an anaesthe-siology perspective, which means they are focused on both acute and chronic pain. In order to cover all perspectives of the pain problem, a multidisciplinary pain treatment concept that included physicians from different disciplines making assessments together was developed. Although this treatment concept once existed at pain clinics coming from the anaesthesiology perspective, treatments at such clinics nowadays mostly include pain medication, local analgesia, invasive interventions and possibly physical and psychological therapies [16]. Assessment and treatment by teams providing MMR are not common in this context. Knowledge about MMR accomplished at pain clinics is scarce and restricted to specific diagnoses or patient groups [17]. MMR has shown beneficial results on a general level, but we still need to improve the knowledge from different settings with different organisations and personnel make-up [13].
The aim of our study was to describe characteristics of patients with complex chronic pain problems treated with a MMR programme at a conventional pain clinic, and evaluate patient-reported outcome measures (PROM) after one year. A secondary aim was to identify predicting factors for the improvement of health-related quality of life at follow-up.
2 Material and methods
2.1 Study design
A clinical, prospective, observational study of patients with non-malignant chronic pain who participated in a MMR programme at a Swedish, conventional pain clinic was performed. Data were collected from patient questionnaires and medical records.
2.2 Setting
The pain clinic is situated at one of the major inner city hospitals in the city of Stockholm, Sweden. The hospital provides care to about half a million inhabitants. Adults are referred to the clinic from primary care, specialist units and occupational health care centres. A prerequisite for assessment and treatment at the pain clinic is a complete medical examination and previous causal treatment of the underlying disease. The pain clinic provides either conventional pain treatment or MMR, depending on the patients’ needs.
2.3 The multimodal rehabilitation programme
Before starting the MMR, the patients were assessed by all members of the team. To be suitable for MMR, the patient had to: be ≥ 18 years old, present complex pain problems with a significant impact on daily function, activity level and quality of life, have motivation for behavioural change, and be sufficiently knowledgeable in Swedish to manage the verbal parts of the MMR.
When the patient was assessed as meeting the inclusion criteria, the treatment started. The MMR programme included coordinated treatment given individually and/or in groups. It was conducted according to cognitive behavioural principles and varied depending on the patient’s needs. The team was defined as an interdisciplinary group, where the patient is also a part, and where cooperation involves regular planning of, and follow-up on, treatment and goals in order to execute MMR. An interdisciplinary team works with joint discussions in a horizontal manner leading to consensus decisions. The team members consisted of a physician, a psychologist, physiotherapists and nurses. All members contributed with their professional roles to the MMR; the physicians adjusted the pharmacological treatment, sickness factors and conducted the mindfulness training, while the psychologist was responsible for cognitive behavioural therapy. The nurses provided the very first visit and assessment, gave instructions to patients in using transcutaneous electric nerve stimulation and did pharmacological follow-up and counselling. The physiotherapists were responsible for physical activities, such as training, exercising in a warm water pool and teaching body awareness therapy. One of the physiotherapists was also trained in acceptance and commitment therapy, which could be one of the individual interventions. Representatives from all the professions participated in the pain self-management courses, which comprised eight sessions. These courses and the training groups comprised about 10 participants on average. A personal contact person, who could be any of the team members, supported each patient in identifying and following up rehabilitation goals. The programme included two to four weekly treatment sessions and lasted for about 3 months. In general the patients participated in activities during 4-6 h each week. The team collaborated with the Swedish Social Insurance Agency and the patients’ employers when required.
2.4 Patients, procedure and outcome measures questionnaires
A consecutive sample was recruited from patients treated with MMR over the period of 2011-2013. The inclusion criteria for the study were the same as for the MMR. As participating in MMR was not restricted regarding diagnosis or old age, the patients in the study had a variety of chronic pain conditions.
The self-assessment questionnaires were handed out to the participants at baseline (i.e. at first visit to the pain clinic), when written consent was also obtained. The 12-month follow-up questionnaires were sent by mail and reminders were resent, if no answers were initially received. The questionnaires included the Swedish translations of seven validated instruments. In addition, questions about pain duration, localisation and intensity, as well as education, country of origin and livelihood were equivalent to those in the questionnaire in the Swedish Quality Registry for Pain Rehabilitation (SQRP). Age and gender were highlighted out from the patients’ records.
Health-related quality of life
The EuroQol-5D-3L questionnaire (EQ-5D) is a generic instrument for describing and valuing health-related quality of life by the dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression [18]. The EQ-5D index, based on the English value set, was our primary outcome [19]. In the second part of the EQ-5D, the person rates his present health state (EQVAS) on a 0-100 thermometer scale, where the endpoints are defined as the worst imaginable health state and best imaginable health state respectively [18].
Insomnia
The Insomnia Severity Index (ISI) [20,21] is a self-response questionnaire aimed at detecting insomnia in community or clinical settings and evaluating treatment. The ISI assesses seven dimensions of insomnia, including, for example, sleep onset and maintenance, early morning awakening problems and interference of sleep with daily activity, on a 5-point Likert scale ranging from 0 = no problems to 4 = very severe problems. A total score was then summed up. Cut-off points for insomnia were found to be at ≤ 7 for no insomnia, 8-14 for subthreshold, 15-21 for moderate insomnia and ≥ 22 for severe insomnia, [21].
Pain intensity
We used a 100 mm horizontal Visual Analogue Scale (VAS) to assess current pain intensity. To categorise our data the cut-off points recently described were found to be adequate with ≤34 as mild, 35-64 as moderate and ≤65 as severe interference with function [22].
Pain disability
To evaluate pain-related disability, the 7-item questionnaire Pain Disability Index (PDI) was used [23,24]. The patient assessed the impact of pain on different activities on a 10-point Likert scale, which was summarised into a total score (range 0-70). In chronic back pain patients, clinically significant changes of 8.5-9.5 points are described for the total score [25].
Mental health
The Hospital Anxiety and Depression Scale (HADS) [26] was used to assess mental health. The questionnaire was developed to screen anxiety and depression in a clinical population with physical illness and has shown validity and reliability in different contexts [26,27]. It consists of 7 items related to anxiety and 7 items for depression. Each item includes 4-point Likert scales (range 0-3), and a total score is summed up from each subscale. In the present study, the 2 subscales are used with the cut-off points of ≤7 for no cases, 8 to 10 for doubtful cases, and ≥11 for definite cases [26].
Sense of coherence
The Sense of Coherence Scale (SOC) is based on Antonovsky’s salutogenetic model [28]. He stated that an individual’s reaction to stressors depends on their sense of coherence. The sense of coherence concept is described as an individual’s global view on life as manageable, comprehensible and meaningful, thereby contributing to the experience of health. SOC has been identified to predict quality of life in longitudinal studies [29], still its importance for the outcome of pain rehabilitation programmes need more research [30]. The 13-item version of the SOC was used in our study. The items are formulated as questions where the individual has to rate their feelings on a Likert scale (1-7 points). The scores can be added to a total score or in three subscales representing the different components of the concept. The questionnaire has been discussed and found to be valid and reliable [31]. Weak SOC is estimated at a cut-off of ≤57 and strong SOC as ≥75 [30,31].
Kinesiophobia
Fear of movement and (re)injury was measured by the Tampa Scale of Kinesiophobia (TSK) [32]. Its 17 items are assessed on a 4-point Likert-scale ranging from strongly disagree to strongly agree. Ratings are summed up (range 17-68) and a higher score indicates greater kinesiophobia. Subgroups of low (17-33), mild (34-41) and high (42-68) kinesiophobia were identified in a study of MMR in low back pain [33].
Number of pain sites
To chart the presence of local or widespread pain, the number of pain sites (NPS), was assessed by the questions from the SQRP. Patients were asked to tick their pain localisation in descriptions of 18 areas represented at both right and left half of the body (total 36 areas) as well as to choose one out of 11 possibilities indicating the worst pain area.
Statistics
SPSS version 22 software was used for data analysis. As all questionnaires are patient-reported outcome measures (PROM) on an ordinal level, non-parametric statistics were used. To compare the results with previous studies, mean and standard deviation (SD) were reported. To analyse the change from baseline to follow-up, the Wilcoxon sign rank test was used. We also compared the baseline values of the questionnaires (EQ-5D, HADS, ISI, PDI, TSK, SOC and VAS) and demographic variables (age, gender, education and country of origin) between the responders with valid values at baseline and follow-up and the drop-outs with missing values at follow-up, with a Mann-Whitney U-test. P-values < 0.05 were considered to be significant.
To study the association between the independent variables (age, gender, country of origin, education, PROM and SOC at baseline) and the primary outcome EQ-5D-index, binary logistic regression analysis was performed. To dichotomize the EQ-5D index, the earlier described minimal clinically important change (MCIC) of 0.1 [34] was used to differentiate either increased or unchanged/decreased (1 = patients with EQ-5D index increased by > 0.1 and 0 = patients with EQ-5D index decreased or unchanged). The independent variables were also dichotomized and coded as binary variables in age (≤40 years, ≥41), country of origin (Sweden, abroad), education (primary/secondary school, university), EQVAS (low ≤32, high ≥33), ISI (no or moderate problems ≤21, severe problems ≥22), HADS (no or doubtful cases ≤10, definite cases ≤11), VAS (mild/moderate ≤64, severe ≥65), SOC (weak ≤57, moderate/strong ≥58), PDI (low ≤40, high ≥41) and TSK (low ≤41, high ≥42). In addition, the variables with a significant change over time (EQVAS, ISI, PDI and TSK) as well as the HADS were tested in regression models as dependent variables.
For each outcome both univariable and multivariable analyses were done. First, the crude association between the outcomes and each of the independent variables were studied. Second, to study if the crude association changed due to possible confounders, the adjusted association between the outcome and all independent variables was studied. We report odds ratios and corresponding 95% confidence intervals.
Ethical considerations
The study was approved by the Regional Ethical Review Board, Stockholm (Dnr: 2010/1903-31/5) with a supplementary application (Dnr: 2012/75-32). Patients got oral and written information about the study and written consent was obtained by the participants before inclusion.
3 Results
3.1 Baseline assessment
The study participants’ demographics are presented in Table 1. Most patients were born in Sweden. A higher education level was found in about half of the patients, and one person was retired. The sample represents substantial pain problems with low HRQoL, moderate insomnia, pain-related disability, kinesiophobia, moderate current pain, multiple numbers of pain sites, and presence of doubtful cases of anxiety and depression. In Table 2, PROM, SOC, pain localisation and pain duration at baseline are presented. Missing data were imputed from patients’ records for pain duration (n = 4) and for localisation of the worst pain (n = 10). The three main pain locations reported were neck and shoulder (31%), upper and lower back (28%) and various pain areas (28%). Seven patients had divergent high scores on the EQ-5D index and were also in the other measurements in good conditions. Most patients had pain duration ≥ 2 years (Table 2). At baseline, 19 patients had salaries to some degree, 23 were on sick leave to some degree, and 7 lived on other allowances, such as those for being unemployed, receiving financial aid for studies, or required livelihood support. Eight persons defined livelihood as other, citing examples, such as pensions, parents or nothing.
Descriptive statistics for patients’ demographics at baseline; n (%).
| Gender | |
| Female | 38 (90.5) |
| Male | 4 (9.5) |
| Age | |
| Mean (SD)/md (min-max) | 43.6 (15.7)/46 (20-76) |
| Country of origin | |
| Born in Sweden | 32 (76.2) |
| Born in Nordic country | 1 (2.4) |
| Born in other European country | 3 (7.1) |
| Born outside of Europe | 6 (14.3) |
| Education | |
| Primary school only | 7 (17) |
| Secondary school or vocational training | 22 (52) |
| University | 9 (21) |
| Other | 4 (10) |
| Family status | |
| Living alone | 9 (21) |
| Living with family/children | 21 (50) |
| Living with spouse | 8 (19) |
| Other | 4 (10) |
Patient-reported outcome measures, sense of coherence, pain localisation, and pain duration at baseline.
| n | Mean | (SD) | Median | (Min–max) | ||
|---|---|---|---|---|---|---|
| EQ-5D Index | 39 | 0.1 | (0.282) | –0.005 | (–0.239–0.689) | |
| EQVAS | 39 | 32.67 | (20.1) | 30 | (0–75) | |
| HADS anxiety | 41 | 9.78 | (3.95) | 10 | (2–17) | |
| HADS depression | 39 | 9.35 | (4.1) | 10 | (0–16) | |
| ISI | 40 | 18.95 | (6.7) | 19 | (6–28) | |
| PDI | 37 | 40.97 | (12.4) | 41 | (18–60) | |
| TSK | 35 | 40.8 | (9.8) | 41 | (19–62) | |
| SOC | 37 | 51.37 | (14) | 49 | (22–84) | |
| VAS current pain | 39 | 61.31 | (20.4) | 62 | (15–100) | |
| Number of pain sites | 42 | 16 | (8.6) | 14.5 | (3–36) | |
| Localisation of worst pain | n(%) | |||||
|
|
||||||
| Neck, shoulder and arm | 13 (31) | |||||
| Abdomen | 3 (7.1) | |||||
| Back upper and lower | 12 (29) | |||||
| Legs | 2 (5) | |||||
| Worst area varies | 12 (29) | |||||
| Pain duration | n (%) | |||||
|
|
||||||
| ≤6 months | 2 (5) | |||||
| 7–24 months | 5 (12) | |||||
| ≤25 months | 35 (83) | |||||
SD: Standard deviation; EQ-5D: EuroQol-5 dimension Index; EQ VAS: EuroQol-5 dimension Visual Analogue Scale; VAS: Visual Analogue Scale; HADS: Hospital Anxiety and Depression Scale; ISI: Insomnia Severity Index; SOC: Sense of Coherence Scale; PDI: Pain Disability Index; TSK: Tampa Scale of Kinesiophobia
The drop-out analysis of responders at baseline and follow-up compared to responders representing only baseline data (demographics, PROM and SOC) showed no significant difference between responders and partial responders (p ≥ 0.05).
3.2 Changes over time
The changes of PROMs from baseline to one year later are shown in Table 3. Statistical significant improvements at follow-up were found on the variables EQ-5D-index, EQ VAS, ISI, PDI and TSK. No significant changes were detected for anxiety, depression, pain intensity and sense of coherence. Sleep problems were improved from one severity category to another severity category for 13 patients (50%), unchanged for 8 (30%) and worsening for 5 patients (20%). The PDI decreased more than 9 points for 12 (48%) patients, was unchanged for 9 (36%) and increased for 4(16%). Kinesiophobia decreased from one severity category to another severity category for 9 (36%) patients, was unchanged for 14(56%), and got worse for 2 (8%) on the TSK.
Changes in patient-reported outcomes of HRQoL, pain, pain-related symptoms and sense of coherence.
| Baseline | 1-year follow–up | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | Mean | (SD) | Median | (Min–Max) | Mean | (SD) | Median | (Min–Max) | p–value | |
| EQ–5D Index | 29 | 0.136 | (0.314) | 0.03 | (–0.239–0.689) | 0.354 | (0.379) | 0.587 | (–0.349–0.796) | 0.003 |
| EQ VAS | 24 | 36.25 | (19.2) | 36 | (10–75) | 52.08 | (22.2) | 63 | (14–80) | 0.011 |
| HADS anxiety | 29 | 9.82 | (3.4) | 10 | (2–17) | 9.41 | (4.7) | 10 | (1–19) | 0.534 |
| HADS depression | 27 | 9.74 | (4.4) | 10 | (0–16) | 8.18 | (4.8) | 8 | (0–17) | 0.062 |
| ISI | 26 | 18.07 | (6.8) | 19 | (6–28) | 14.6 | (5.8) | 15 | (5–28) | 0.008 |
| SOC | 26 | 51.23 | (12.8) | 49 | (22–75) | 53.03 | (15.4) | 54 | (27–83) | 0.484 |
| PDI | 25 | 39.48 | (12.6) | 41 | (18–60) | 33 | (14.8) | 33 | (7–57) | 0.032 |
| TSK | 25 | 40.04 | (10.1) | 41 | (19–62) | 35.6 | (10.01) | 35 | (21–66) | 0.020 |
| VAS current pain | 27 | 57.74 | (20.4) | 58 | (15–100) | 49.56 | (23.9) | 50 | (3–100) | 0.075 |
Wilcoxon sign rank test: p ≤ 0, 05 (significant changes in bold); SD: standard deviation; EQ-5D: EuroQol-5 dimension Index; EQ VAS: EuroQol-5 dimension Visual Analogue Scale; VAS: Visual Analogue Scale; HADS: Hospital Anxiety and Depression Scale; ISI: Insomnia Severity Index; SOC: Sense of Coherence scale; PDI: Pain Disability Index; TSK: Tampa Scale of Kinesiophobia
The majority of patients reported no changes to livelihood (i.e. salary) at follow-up (n = 8), sick leave (n = 14), other allowances such as being unemployed, receiving financial aid for studies or required livelihood support (n = 5). Changes were reported by six patients who at follow-up obtained salary instead of sick leave, seven patients who had changed the other way-from salary to sick leave, and two who went from salary to other allowances.
3.3 Associations for the improvement of PROM
The univariable logistic regression analysis for the primary outcome EQ-5D index is shown in Table 4. No significant associations were found between the baseline variables and an increased EQ-5D index or unchanged/diminished EQ-5D index at follow-up. An adjusted model, with the independent variables as covariates, did not show any significant associations either; nor could any significant associations be identified for the other increased variables (EQ VAS, ISI, PDI or TSK) and HADS and the baseline variables.
Associations between increment in EQ-5D index (≥0.1 difference between baseline and 12-month follow-up) and different independent variables.
| Univariable binary logistic regression analysis | ||||||
|---|---|---|---|---|---|---|
| n total | % with increment EQ–5D index | OR | 95% CI | p–value | ||
| Sex | Male | 3 | 33.3 | ref | ||
| Female | 26 | 53.8 | 2.33 | 0.19–29 | 0.510 | |
| Age | ≤40 years | 10 | 70 | 3.20 | 0.63–16 | 0.161 |
| ≥41 years | 19 | 42.1 | ref | |||
| Country of origin | Sweden | 22 | 54.5 | 1.6 | 0.29–8.9 | 0.591 |
| Abroad | 7 | 42.9 | ref | |||
| Education | Primary/secondary school | 24 | 50 | ref | ||
| university | 5 | 60 | 1.5 | 0.211–10.649 | 0.685 | |
| EQ–VAS | ≤32 (low) | 13 | 61.5 | 2.13 | 0.46–9.94 | 0.335 |
| ≥33 (high) | 14 | 42.9 | ref | |||
| ISI | ≤21 (No problems/subthreshold/moderate) | 20 | 50.0 | ref | ||
| ≥22 (severe) | 9 | 55.6 | 1.25 | 0.26–6.07 | 0.782 | |
| HADS–anxiety | ≤10 (no/doubtful cases) | 17 | 52.9 | 1.35 | 0.29–6.18 | 0.699 |
| ≥11 (definite cases) | 11 | 45.5 | ref | |||
| HADS–depression | ≤10 (no/doubtful cases) | 16 | 37.5 | ref | ||
| ≤11 (definite cases) | 12 | 66.7 | 0.6 | 0.69–16.02 | 0.133 | |
| VAS current pain | ≥64 (mild/moderate) | 17 | 41.2 | ref | ||
| ≥65 (severe) | 11 | 63.6 | 2.5 | 0.52–11 | 0.250 | |
| PDI | ≤40 (low) | 12 | 50 | ref | ||
| ≥41 (high) | 14 | 57.1 | 1.33 | 0.28–6.28 | 0.716 | |
| SOC | ≤57 (weak) | 19 | 63.2 | 5.14 | 0.81–32 | 0.083 |
| ≤58 (moderate/strong) | 8 | 25.0 | ref | |||
| TSK | ≤41 (low) | 13 | 46.2 | ref | ||
| ≤42 (high) | 12 | 50.0 | 1.17 | 0.24–5.62 | 0.848 | |
OR: odds ratio; CI: confidence interval; EQ-5D: EuroQol-5 dimension Index; EQ VAS: EuroQol-5 dimension Visual Analogue Scale; VAS: Visual Analogue Scale; HADS: Hospital Anxiety and Depression Scale; ISI: Insomnia Severity Index; SOC: Sense of Coherence Scale; PDI: Pain Disability Index; TSK: Tampa Scale of Kinesiophobia. p ≤ 0.05
4 Discussion
A one-year follow-up of patients with complex chronic pain problems participating in a MMR programme at a conventional pain clinic showed improvement in health-related quality of life, insomnia, pain-related disability and kinesiophobia. Our study does not provide any suggestions of which, or if any baseline conditions can be associated with the increase of HRQoL.
In accordance with the aim of our study, we described patients’ characteristics of a sample treated with a MMR programme at a conventional pain clinic. The patients represented complex chronic pain problems, including, low HRQoL, insomnia, disability and kinesiophobia, as well as possible presence of anxiety and depression. The patients’ work ability was affected, as more than half won some part of sick leave. Similar severe pain problems are often reported by patients referred to specialised clinical rehabilitation departments in Sweden, and treated with MMR [35,36]. Thus, this group of patients suffer from a severe complexity of chronic pain.
A well-conducted assessment is not only important for planning interventions [36], but also seems to have an impact on the outcome itself [14,37]. The assessment of the individual’s need of MMR in our study was done by a small, interdisciplinary, experienced team that was relatively stable over time. The assessment moment is an opportunity for the team to see the patient from a holistic perspective according to the biopsychosocial model. It also gives the patient the possibility to feel that she is an important person and is being treated as an equal. In a previous study, we found that such an empowering encounter was important for patients with chronic pain to change towards acceptance of pain and a possible new identity [38]. The MMR team should continuously strengthen patients’ empowerment through conscious strategies during the treatment period.
At one-year follow-up after a MMR programme, significant improvement was found in several areas. According to our hypothesis, the main outcome EQ-5D index improved significantly as well as did the EQ VAS. As the EQ-5D index includes five domains, it could be assumed that the findings may also be seen in the specific instruments for disability (PDI), pain intensity (VAS), and anxiety and depression (HADS). Both disability and kinesiopho-bia were improved, which is consistent with the first three items of the EQ-5D index. Kinesiophobia has been identified as a factor for having experienced disability in women [39]. The two last items (pain/discomfort and anxiety/depression) in the EQ-5D index weighs heavily in the index calculation. Despite the fact that neither depression and anxiety nor current pain showed significant improvement in our follow-up, the EQ-5D index improved. That means, patients improved most in function and activity, and/or pain and mental health slightly improved. Improvement from one severity group into another in depression was found in 33% and 66% were unchanged, which is in line with the results from SQRP in general [40].
Disability rated on the PDI at baseline was high (39.48 ±12.64) and in accordance with mixed diagnosis chronic pain patients treated with an interdisciplinary outpatient programme in Switzerland [41]. In contrast, a homogenous group of patients with low back pain studied in the Netherlands showed lower PDI [25], and the results were thereby clearly higher than the scores of a normal population (6.8 ± 11.4) [24]. In the 12-month follow-up, our study showed significant improvement of the PDI, but did not reach the clinical important change, which was declared to be a reduction of 8.5-9.6 points for patients with chronic low back pain in the Dutch study [25]. In the Swiss study mentioned, the one-year follow-up of the PDI showed a return to baseline value, though with significant improvement post-treatment.
The connections of depression, insomnia and chronic pain are complex and a topic for ongoing discussion [42]. A synchrony of the symptoms seems to exist [43-45], and can be explained in biopsy-chosocial terms [7,10]. Since the symptoms are intertwined, the clinician has to address them all when assessing patients and planning interventions [9,45]. Although sleep disturbance is common in patients with chronic pain, PROM for insomnia are seldom reported in clinical studies [8]. The present one-year follow-up showed statistically increased quality of sleep. Further, half of the patients improved from one clinical severity group of insomnia to a less severe group, though the median value was still in the group of moderate insomnia. Clearer changes (mean -6.6) in ISI have been reported in patients with chronic disabling occupational muscu-loskeletal disorders of mostly spinal origin [46]. Our results can be elucidated by the findings of patients’ experiences described in a qualitative study, where the informants mentioned disturbed sleep as a problem before rehabilitation, but not as a topic for discussion when talking about daily life one year later [38].
As systematic reviews and later studies have shown, MMR improves function and mental health, and lessens disability and pain, thereby improving HRQoL in patients with chronic pain [11,12,14,33,47,48] but many questions still remain. Subjects of interest would be, for example, to study patients’ characteristics at different settings, the significance of the different components of MMR, or the comparison of MMR programmes with different durations [11]. What our study adds to previous knowledge is a description of patients at a conventional pain clinic and that a MMR programme can be successful in this context. The heterogeneous group of patients in our study had improved HRQoL, diminished disability and slightly, though not statistically significant, decreased pain after one year. Participation in working life in our study showed that patients changed from sick leave to salary, although some others also did the opposite. These findings are in line with the description of patients’ experiences of a MMR programme in our previous qualitative study, where the informants described a functional life worth living, but with an everyday ongoing struggle with pain and its related symptoms one year after MMR. The informants’ descriptions included that the ability to work was extended when they had understanding workmates, which brings to light the complex situation according to the biopsychoso-cial model [38].
The method of this study has some limitations. The design as an observational study with a selection by protocol means inherent weakness. The study was integrated into ongoing health care with the pragmatic possibility of getting more information about this population. Clinical studies with pragmatic design have limitations related to lack of control groups or randomisation, but can provide important information on what is happening in a clinical context when patients act as their own controls [49]. The study design made it possible to include patients who represented mixed diagnoses and participated in an individually adapted programme, as opposed to a standardised intervention as in a randomised controlled trial. In opposite to many other pain rehabilitation programmes, pharmacological stable treatment was not an inclusion criteria. Thus the significance of drugs can not be omitted, which is a limitation in our study. The importance and outcome of such patient-centred treatment needs evaluation, but the variety of preconditions makes the comparison of different programmes difficult. To be able to get a deeper understanding of the findings would require re-examining them with findings from qualitative studies.
The lack of statistically significant changes in some PROM at follow-up or in the regression analysis may be explained by the small sample size related to the clinical situation. As the questionnaires consisted of many items, and we did not use an imputation technique, we had a high frequency of missing data. Motivating patients with chronic pain to answer repetitive multiple questionnaires seems a common problem [33,47]. The low response rate in our study might be linked to the repeated follow-ups, patients’ still burdensome situations and/or general tiredness of inquiries or the paper questionnaires. A more restrictive, but modern digital way of collecting data might give an improved response rate. There was no difference between responders and non-responders regarding the baseline data, so the results of the follow-up might not have been biased. For the regression analysis, a higher response rate might have increased the possibility of identifying associations.
As complex chronic pain is an increasing problem that is treated at different levels of healthcare, more knowledge about the treatment outcome in various clinical contexts is important. One strength of our study is that it sheds light on MMR performed at conventional pain clinics. Another strength is that the sample was also studied with a qualitative method [38], thereby bringing consistent but deeper explanations for the statistical results.
5 Conclusions
MMR for patients with complex pain problems can be a successful treatment alternative at conventional pain clinics.
6 Implications
Patients with complex chronic pain should be offered MMR in order to promote a return to work and increased quality of life [50]. Since access to rehabilitation clinics in Sweden may be limited, the availability of MMR can increase by providing this type of intervention in pain clinics. Increased knowledge of MMR in different settings can also contribute to increased understanding and collaboration between pain clinics and rehabilitation units.
Highlights
Patients with chronic pain treated at a conventional pain clinic showed high complexity of pain and pain-related problems.
Patients’ suffering included very low health-related quality of life, high pain-related disability and insomnia.
One year after a multimodal rehabilitation programme, patients’ health-related quality of life, insomnia, pain-related disability and kinesiophobia had significantly improved.
Multimodal rehabilitation at a conventional pain clinic is a successful treatment option.
DOI of refers to article: http://dx.doi.org/10.1016/j.sjpain.2015.11.001.
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Conflict of interest
Conflict of interest statement: The authors have no conflict of interest.
Acknowledgements
We thank the statisticians Lina Benson and Hans Pettersson at Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm for their help, as well as the Scandinavian Association for the Study of Pain for their financial support.
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