Phase
Condition
Chronic Pain
Treatment
Usual physiotherapy care
Individualized (STOPS) physiotherapy
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
A primary complaint of either:
low back pain, defined as pain between the inferior costal margin and theinferior gluteal fold with or without referral into the leg(s)or
referred leg pain, defined as predominately unilateral posterior leg painextending below the knee, or anterior thigh pain, with or without back pain
Duration of the current episode of primary complaint lasting for greater than 3months (chronic stage of the injury)
Aged between 18 and 65 (inclusive)
Fluency in English or Bengali sufficient to complete questionnaires and to enableunderstanding of the intervention
Agreeing to refrain from other interventions wherever possible for the 10-weektreatment period of the trial, aside from consultations with medical practitioners,medication, and any exercises already being undertaken
Exclusion
Exclusion Criteria:
Physiotherapist:
Not willing to participate in the study for all 3 phases.
Patient:
Red flag pathologies such as active cancer under current treatment, risk of spinalfracture, signs of potential infection, and major systemic inflammatory disease.
Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging
Current pregnancy, or childbirth within the last 6 months, as this could impair theability to undertake exercises, and could also cause back and leg symptoms that arenot related to the subgroups under investigation
Spinal injections within the last 6 weeks, as we wish to study treatment effectsindependent of the effects of injections
Any history of lumbar spine surgery, as there is already considerable researchevaluating the efficacy of post-surgical rehabilitation programs
A pain intensity score of less than 2/10 on the numerical pain rating scale due tolow severity.
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 wewish to exclude people with low severity.
Inability to walk safely, such as severe foot drop causing regular tripping, as theinterventions in the trial include walking for most participants.
Planned absence of more than one week during the treatment period (such asholidays).
Study Design
Study Description
Connect with a study center
Uttara Adhunik Medical College Hospital
Dhaka, Uttara 1230
BangladeshActive - Recruiting
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