Evaluating a new physiotherapy approach for chronic low back pain in Bangladesh

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This implementation trial aims to compare the effectiveness of the Specific Treatment of Problems of the Spine (STOPS) approach against usual physiotherapy care for patients suffering from chronic low back pain (CLBP) in Bangladesh. The trial will involve treating patients with CLBP using standard physiotherapy in the first phase, followed by training Bangladeshi physiotherapists in the STOPS method in the second phase. In the third phase, these trained physiotherapists will provide treatment using the STOPS approach, and patient outcomes will be assessed before and after the implementation. Additionally, the study will evaluate the cost-effectiveness of STOPS physiotherapy and the impact of training on physiotherapists' confidence and care quality.

Why it matters

Who can join: the full rules

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).

Where it's running

• Uttara Adhunik Medical College Hospital
  Dhaka, Uttara, Bangladesh Recruiting

Study contacts

• Principal investigator: Mohammad Ali, MPhil — Uttara Adhunik Medical College Hospital
• Study coordinator: Mohammad Ali, MPhil
• Email: mohammad.ali@latrobe.edu.au
• Phone: (88) 01715043533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.