Implementation of the Specific Treatment Of Problems of the Spine Approach in Bangladesh

Study Overview
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Brief Summary
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The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are: Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP? Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP. Does STOPS training improve the quality of care among Bangladeshi physiotherapists?

Detailed Description
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The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are: Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP? Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP. Does STOPS training improve the quality of care among Bangladeshi physiotherapists? In phase I, patients with CLBP will be treated with usual physiotherapy care. In phase II, Bangladeshi physiotherapists will be provided with a STOPS training program by the Australian developers of STOPS. In phase III, the trained Bangladeshi physiotherapists will treat patients using the STOPS approach. Clinical patient outcomes will be evaluated in Phase 1 and Phase 3 (pre and post implementation). Physiotherapists' self-confidence and implementation behaviour will be evaluated before and after STOPS training. A qualitative study of physiotherapists' and patients' experiences will be conducted after the completion of the usual care (Phase I) and STOPS treatment programs (Phase III).

Official Title
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Implementation of the Specific Treatment Of Problems of the Spine (STOPS) Approach in Bangladesh: A Prospective Sequential Comparison

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Usual physiotherapy care
* Other: Individualized (STOPS) physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physiotherapists: Qualified physiotherapists and physiotherapy assistants in Bangladesh who are involved in low back pain management and working in either or both trial settings will provide the treatment in phases 1 and 3. To be eligible, physiotherapists and physiotherapy assistants must be willing to participate in all phases of the trial (Phases I, II, and III). They must have completed the organised STOPS training course led by the original Australian developers (Jon Ford and Andrew Hahne), where the assessment and treatment protocols will be taught in Phase II. Patients: A primary complaint of either: low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s) or referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury) Aged between 18 and 65 (inclusive) Fluency in English or Bengali sufficient to complete questionnaires and to enable understanding of the intervention Agreeing to refrain from other interventions wherever possible for the 10-week treatment period of the trial, aside from consultations with medical practitioners, medication, and any exercises already being undertaken Exclusion Criteria: Physiotherapist: Not willing to participate in the study for all 3 phases. Patient: Red flag pathologies such as active cancer under current treatment, risk of spinal fracture, signs of potential infection, and major systemic inflammatory disease. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging Current pregnancy, or childbirth within the last 6 months, as this could impair the ability to undertake exercises, and could also cause back and leg symptoms that are not related to the subgroups under investigation Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs A pain intensity score of less than 2/10 on the numerical pain rating scale due to low severity. Minimal activity limitation, evidenced by a baseline ability to perform ALL of (walk, sit, and stand for one hour or more and no sleep disturbance at night), as we wish to exclude people with low severity. Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants. Planned absence of more than one week during the treatment period (such as holidays).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual physiotherapy care<br>One physiotherapy assessment, 10 x 45-minute sessions of usual care physiotherapy (over a 10-week period), plus 1 x 45-minute followup session of usual care physiotherapy after 6 months. | Other: Usual physiotherapy care<br>* In Phase 1, physiotherapists will provide treatment for participants with chronic low back pain in accordance with their current standard physiotherapy practice. Physiotherapists will be free to choose the treatment approach they wish to.<br>|
| Experimental: Individualized (STOPS) physiotherapy<br>One physiotherapy assessment, 10 x 45-minute sessions of individualised (STOPS) physiotherapy (weekly for 10 weeks), plus 1 x 45-minute followup session of individualised (STOPS) physiotherapy after 6 months. | Other: Individualized (STOPS) physiotherapy<br>* In Phase 3, participants will receive individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach modified for chronic low back pain. Treatment will be individualized on the basis of biopsychosocial assessment findings including dominant pain type (nociceptive, neuropathic or nociplastic), pathoanatomical subgroups (if any), and other barriers to recovery (eg. inflammation, depression, anxiety, stress, catastrophising, pain self-efficacy, and unhelpful motor control strategies). Available treatment strategies will include individualized education/advice, exercise, manual therapy, activity modification/facilitation, goal setting, motor control optimisation, cognitive-behavioural strategies, inflammation management, pain management strategies, sleep management, work management, and relaxation approaches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity limitation | Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability. | Primary endpoint will be 26 weeks post-enrolment. | 
| Back Pain Intensity | 0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome. | Primary endpoint will be 26 weeks post-enrolment. | 
| Leg Pain Intensity | 0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome. | Primary endpoint will be 26 weeks post-enrolment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work hours missed | Number of work/housework hours missed during the past 7 days (continuous scale from 0 to 50). Lower score indicated less hours missed (better outcome) | 5, 10, and 26-weeks post enrolment | 
| Work productivity | 0-10 numerical rating scale of how much pain affected work productivity in the last 7 days. Score 0-10, with lower scores indicating less interference with work productivity. | 5, 10, and 26-weeks post enrolment | 
| Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF) | The total score ranges between 1 and 100, with higher scores indicating a worse outcome. | 5, 10, and 26-weeks post enrolment | 
| Health-related quality of life (EQ-5D-5L) | Utility scores will be calculated from the EuroQOL-5D-5L, with scores ranging from -0.148 to 0.949 (higher scores indicate better quality of life) | 5, 10, and 26-weeks post enrolment | 
| Depression, Anxiety and Stress Scales - DASS-21 | The DASS-21 measures symptoms of stress, anxiety and depression, with a total composite score ranging from 0-63 with higher scores indicating more severe symptoms of distress. | 5, 10, and 26-weeks post enrolment | 
| Pain Self Efficacy | Pain Self Efficacy Questionnaire (PSEQ). A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain (better outcome). | 5, 10, and 26-weeks post enrolment | 
| Pain Catastrophizing | Pain Catastrophizing Scale (PCS). The score ranges from 0 to 52. A higher score denotes more catastrophizing (worse outcome) | 5, 10, and 26-weeks post enrolment | 
| Sleep quality | Insomnia Severity Index (ISI-7). Score ranges from 0 to 28, with higher scores indicating worse sleep quality (worse outcome) | 5, 10, and 26-weeks post enrolment | 
| Central Sensitisation symptoms | Central Sensitisation Inventory (CSI-9). Score ranges from 0 to 36, with higher scores indicating more symptoms indicative of potential central sensitisation | 5, 10, and 26-weeks post enrolment | 
| Inflammatory symptoms | The 4-item clinical inflammation score will measure low back-related inflammatory symptoms. Scores range from 0 to 4, with higher scores indicating more inflammatory symptoms (worse outcome) | 5, 10, and 26-weeks post enrolment | 
| Treatment Credibility | Treatment credibility questionnaire. Scored 0-10. A higher score indicates greater confidence in the treatment (better outcome). | 5, 10, and 26-weeks post enrolment | 
| Healthcare utilization | A patient diary will be used to track healthcare service utilization, imaging, and medication. These are recorded descriptively. | 5, 10, and 26-weeks post enrolment | 
| Participant adherence with treatment | Participant adherence with treatment will be determined via a self-administered 0-10 rating scale, with higher scores indicating greater adherence with treatment (better outcome). | 5, 10, and 26-weeks post enrolment | 
| Global rating of change | Global change will be measured on a 7-point scale ranging from very much worse to very much better. Scores range from 1-7, with a higher score indicating greater improvement. | 5, 10, and 26-weeks post enrolment | 
| Satisfaction with treatment | Participants will rate their satisfaction with physiotherapy treatment on a 5-point Likert scale, with ratings from very satisfied to very dissatisfied. | 5, 10, and 26-weeks post enrolment | 
| Adverse events | Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes. | 5, 10, and 26-weeks post enrolment | 
| Qualitative interviews | Semi-structured interviews relating to the patient's experiences with the Usual care and STOPS physiotherapy will be conducted. | 10 weeks post-enrolment | 
| Pain severity | Brief Pain Inventory. Average of the four pain severity items, scores range from 0-10, lower scores indicate less pain severity. | 5, 10, and 26-weeks post enrolment | 
| Pain interference | Brief Pain Inventory. Average of the seven pain interference items, scores range from 0-10, lower scores indicate less pain interference. | 5, 10, and 26-weeks post enrolment | 
| Back Pain Intensity | 0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome. | 5, 10 and 52-weeks post enrolment | 
| Leg Pain Intensity | 0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome. | 5, 10 and 52-weeks post enrolment | 
| Activity limitation | Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability. | 5, 10 and 52-weeks post enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Physiotherapy, Usual care, STOPS, Implementation trial, Bangladesh, Physiotherapist