Implementation of the Specific Treatment of Problems of the Spine Approach in Bangladesh (STOPS-Bangla)

Mohammad Ali

Status: Enrolling

Conditions: Chronic Low-back Pain

Treatments: Other: Usual physiotherapy care; Other: Individualized (STOPS) physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05880212

HEC22334

Details and patient eligibility

About

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?

Full 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).

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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154 participants in 2 patient groups

Usual physiotherapy care

Active Comparator group

Description:

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.

Treatment:

Other: Usual physiotherapy care

Individualized (STOPS) physiotherapy

Experimental group

Description:

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.

Treatment:

Other: Individualized (STOPS) physiotherapy