Evaluating a new physiotherapy approach for chronic low back pain in Bangladesh
Implementation of the Specific Treatment Of Problems of the Spine (STOPS) Approach in Bangladesh: A Prospective Sequential Comparison
This study is testing a new physiotherapy method called STOPS to see if it helps people in Bangladesh with chronic low back pain feel better compared to regular physiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Uttara Adhunik Medical College Academic / other |
| Locations | 1 site (Dhaka, Uttara) |
| Trial ID | NCT05880212 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing chronic low back pain or referred leg pain lasting for a significant duration.
Not a fit: Patients with acute low back pain or those not willing to participate in all phases of the trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and cost-efficient treatment options for patients with chronic low back pain.
How similar studies have performed: Other studies have shown promising results with similar physiotherapy approaches, suggesting potential for success in this implementation trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dhaka, Uttara
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.