RecruitingNot ApplicableNCT05880212

Implementation of the Specific Treatment of Problems of the Spine Approach in Bangladesh

Implementation of the Specific Treatment of Problems of the Spine (STOPS) Approach in Bangladesh: a Prospective Sequential Comparison

Sponsor

Mohammad Ali

Enrollment

154 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Low-back Pain

Summary

The goal of this implementation trial is to evaluate the clinical outcomes associated with usual physiotherapy care compared to individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach in patients with chronic low back pain (CLBP). The main questions it aims to answer are: * Is the STOPS approach more effective than usual care physiotherapy among patients with CLBP? * Is STOPS physiotherapy cost-effective compared to usual physiotherapy care for patients with CLBP. * Does STOPS training improve the quality of care among Bangladeshi physiotherapists?

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria11

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 the inferior gluteal fold with or without referral into the leg(s)
or
referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain
Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)
Aged between 18 and 65 (inclusive)
Fluency in English or Bengali sufficient to complete questionnaires and to enable understanding of the intervention
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 Criteria12

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 spinal fracture, 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 the ability to undertake exercises, and could also cause back and leg symptoms that are not related to the subgroups under investigation
Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections
Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs
A pain intensity score of less than 2/10 on the numerical pain rating scale due to low 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 we wish to exclude people with low severity.
Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants.
Planned absence of more than one week during the treatment period (such as holidays).

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Interventions

OTHERUsual physiotherapy care

In Phase 1, physiotherapists will provide treatment for participants with chronic low back pain in accordance with their current standard physiotherapy practice. Physiotherapists will be free to choose the treatment approach they wish to.

OTHERIndividualized (STOPS) physiotherapy

In Phase 3, participants will receive individualized physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach modified for chronic low back pain. Treatment will be individualized on the basis of biopsychosocial assessment findings including dominant pain type (nociceptive, neuropathic or nociplastic), pathoanatomical subgroups (if any), and other barriers to recovery (eg. inflammation, depression, anxiety, stress, catastrophising, pain self-efficacy, and unhelpful motor control strategies). Available treatment strategies will include individualized education/advice, exercise, manual therapy, activity modification/facilitation, goal setting, motor control optimisation, cognitive-behavioural strategies, inflammation management, pain management strategies, sleep management, work management, and relaxation approaches.