CTRI/2024/08/072259Not yet recruitingPhase 3
Individualized physiotherapy versus usual care(STOPS trial) for Low Back Disorders in India: A Randomized Clinical Trial - NI
Dr Kavitha Raja0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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),
- •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 primary complaint lasting for greater than 3
- •months (chronic stage of the injury)
- •3. Aged between 18 and 65 (inclusive)
- •4. Fluency in English, Kannada or Hindi languages 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
- •1. Active cancer under current treatment
- •2. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or
- •3. Current pregnancy, or childbirth within the last 6 months
- •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
- •6. A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low
- •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. Already received more than 5 sessions of physiotherapy with any of the treating
- •physiotherapists before enrolment, as these therapists are likely to use many
- •components of the trial treatment protocol on their usual client caseload
- •9. Inability to walk safely, such as severe foot drop causing regular tripping, as the
- •interventions in the trial include walking for most participants
- •10. Planned absence of more than one week during the treatment period (such as
- •overseas holidays)
Investigators
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