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

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain
• Interventions: Other: Usual physiotherapy care; Other: Individualized (STOPS) physiotherapy

• Registration Number: NCT05880212
• Lead Sponsor: Mohammad Ali

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-30
• Study Start: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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:

1. A primary complaint of either:

   1. 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

   2. referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain

2. Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)

3. Aged between 18 and 65 (inclusive)

4. Fluency in English or Bengali sufficient to complete questionnaires and to enable understanding of the intervention

5. 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:

1. Red flag pathologies such as active cancer under current treatment, risk of spinal fracture, signs of potential infection, and major systemic inflammatory disease.
2. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging
3. 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
4. Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections
5. Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs
6. A pain intensity score of less than 2/10 on the numerical pain rating scale due to low severity.
7. 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.
8. Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants.
9. Planned absence of more than one week during the treatment period (such as holidays).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Usual physiotherapy care	Usual physiotherapy care	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.
Individualized (STOPS) physiotherapy	Individualized (STOPS) physiotherapy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Work hours missed	5, 10, and 26-weeks post enrolment	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)
Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)	5, 10, and 26-weeks post enrolment	The total score ranges between 1 and 100, with higher scores indicating a worse outcome.
Pain Self Efficacy	5, 10, and 26-weeks post enrolment	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).
Qualitative interviews	10 weeks post-enrolment	Semi-structured interviews relating to the patient's experiences with the Usual care and STOPS physiotherapy will be conducted.
Work productivity	5, 10, and 26-weeks post enrolment	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.
Health-related quality of life (EQ-5D-5L)	5, 10, and 26-weeks post enrolment	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)
Depression, Anxiety and Stress Scales - DASS-21	5, 10, and 26-weeks post enrolment	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.
Adverse events	5, 10, and 26-weeks post enrolment	Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.
Activity limitation	5, 10 and 52-weeks post enrolment	Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Satisfaction with treatment	5, 10, and 26-weeks post enrolment	Participants will rate their satisfaction with physiotherapy treatment on a 5-point Likert scale, with ratings from "very satisfied" to "very dissatisfied".
Inflammatory symptoms	5, 10, and 26-weeks post enrolment	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)
Healthcare utilization	5, 10, and 26-weeks post enrolment	A patient diary will be used to track healthcare service utilization, imaging, and medication. These are recorded descriptively.
Participant adherence with treatment	5, 10, and 26-weeks post enrolment	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).
Pain severity	5, 10, and 26-weeks post enrolment	Brief Pain Inventory. Average of the four pain severity items, scores range from 0-10, lower scores indicate less pain severity.
Back Pain Intensity	5, 10 and 52-weeks post enrolment	0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Sleep quality	5, 10, and 26-weeks post enrolment	Insomnia Severity Index (ISI-7). Score ranges from 0 to 28, with higher scores indicating worse sleep quality (worse outcome)
Central Sensitisation symptoms	5, 10, and 26-weeks post enrolment	Central Sensitisation Inventory (CSI-9). Score ranges from 0 to 36, with higher scores indicating more symptoms indicative of potential central sensitisation
Global rating of change	5, 10, and 26-weeks post enrolment	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.
Pain interference	5, 10, and 26-weeks post enrolment	Brief Pain Inventory. Average of the seven pain interference items, scores range from 0-10, lower scores indicate less pain interference.
Leg Pain Intensity	5, 10 and 52-weeks post enrolment	0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Pain Catastrophizing	5, 10, and 26-weeks post enrolment	Pain Catastrophizing Scale (PCS). The score ranges from 0 to 52. A higher score denotes more catastrophizing (worse outcome)
Treatment Credibility	5, 10, and 26-weeks post enrolment	Treatment credibility questionnaire. Scored 0-10. A higher score indicates greater confidence in the treatment (better outcome).

Trial Locations

Locations (1)

Uttara Adhunik Medical College Hospital; 🇧🇩 Dhaka, Uttara, Bangladesh