Clinical trial NCT05880212: Implementation of the Specific Treatment of Problems of the Spine Approach in Bangladesh
Official title: Implementation of the Specific Treatment of Problems of the Spine (STOPS) Approach in Bangladesh: a Prospective Sequential Comparison
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic low back pain
Physiotherapy
Usual care
STOPS
Implementation trial
Bangladesh
Physiotherapist
Lead sponsor: Uttara Adhunik Medical College
Sponsor class: OTHER
Collaborators: name: Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC)
name: La Trobe University
First posted: 2023-05-30
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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?

Detailed description: 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?

In phase I, patients with CLBP will be treated with usual physiotherapy care. In phase II, Bangladeshi physiotherapists will be provided with a STOPS training program by the Australian developers of STOPS. In phase III, the trained Bangladeshi physiotherapists will treat patients using the STOPS approach.

Clinical patient outcomes will be evaluated in Phase 1 and Phase 3 (pre and post implementation).

Physiotherapists' self-confidence and implementation behaviour will be evaluated before and after STOPS training.

A qualitative study of physiotherapists' and patients' experiences will be conducted after the completion of the usual care (Phase I) and STOPS treatment programs (Phase III).

Eligibility 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).

Primary outcomes:
measure: Activity limitation
timeFrame: Primary endpoint will be 26 weeks post-enrolment.
measure: Back Pain Intensity
timeFrame: Primary endpoint will be 26 weeks post-enrolment.
measure: Leg Pain Intensity
timeFrame: Primary endpoint will be 26 weeks post-enrolment.
Secondary outcomes:
measure: Work hours missed
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Work productivity
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Health-related quality of life (EQ-5D-5L)
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Depression, Anxiety and Stress Scales - DASS-21
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Pain Self Efficacy
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Pain Catastrophizing
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Sleep quality
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Central Sensitisation symptoms
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Inflammatory symptoms
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Treatment Credibility
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Healthcare utilization
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Participant adherence with treatment
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Global rating of change
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Satisfaction with treatment
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Adverse events
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Qualitative interviews
timeFrame: 10 weeks post-enrolment
measure: Pain severity
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Pain interference
timeFrame: 5, 10, and 26-weeks post enrolment
measure: Back Pain Intensity
timeFrame: 5, 10 and 52-weeks post enrolment
measure: Leg Pain Intensity
timeFrame: 5, 10 and 52-weeks post enrolment
measure: Activity limitation
timeFrame: 5, 10 and 52-weeks post enrolment
Other outcomes:
measure: Physiotherapists' self-confidence in low back pain management
timeFrame: After 26 weeks of phases 1 and 3. After the completion of phase 2 training
measure: Physiotherapists' implementation behaviour
timeFrame: At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.
measure: Physiotherapists' experiences
timeFrame: At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.
measure: Treatment effect modifier: Pain type
timeFrame: Effect modifiers are measured at baseline, and their potential impact determined on outcomes at week 5, 10, and 26
measure: Treatment effect modifier: Disability
timeFrame: Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
measure: Treatment effect modifier: Prognosis (Orebro short-form screening questionnaire)
timeFrame: Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
measure: Treatment effect modifier: Duration of symptoms
timeFrame: Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
measure: Mediator analysis: pain self-efficacy
timeFrame: Change in pain self-efficacy from baseline to 10 weeks and 26 weeks
measure: Mediator analysis: inflammatory symptoms
timeFrame: Change in clinical inflammation score from baseline to 10 weeks and 26 weeks
Locations:
city: Dhaka
country: Bangladesh
facility: Uttara Adhunik Medical College Hospital
state: Uttara
Study officials:
affiliation: Uttara Adhunik Medical College Hospital
name: Mohammad Ali, MPhil
role: PRINCIPAL_INVESTIGATOR
References: