Implementation of the Specific Treatment Of Problems of the Spine (STOPS) approach in Nigeria for persistent low back pain: A prospective sequential compariso
- Conditions
- Musculoskeletal Diseases
- Registration Number
- PACTR202305707317550
- Lead Sponsor
- Federal Medical Centre Nguru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 154
Participants with low back pain presenting to the Federal Medical Centre in Nigeria for treatment during Phase 1 or Phase 3 of the trial will be approached for consent if they meet the following inclusion criteria:
1. A primary complaint of either:
a.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
b.referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain (disc herniation with associated radiculopathy subgroup only)
2. Duration of the current episode of low back pain/leg pain lasting for greater than 3 months
3. Aged between 18 and 65 (inclusive)
4. Fluency in English sufficient to complete questionnaires and to enable understanding of the intervention (English is the primary language in Nigeria)
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
The exclusion criteria will be:
1. Active cancer under current treatment, as the treatment of cancer may interfere with their ability to participate in the trial
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
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 BPI due to low severity
7. Minimal activity limitation, evidenced by a baseline ability to 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 overseas holidays)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient outcomes 1) Average back pain intensity over the last week, measured on the 0-10 numerical rating scale, 2) Average leg pain intensity over the last week, measured on the 0-10 numerical rating scale<br>3) Activity limitation Oswestry Disability Questionnaire<br>
- Secondary Outcome Measures
Name Time Method