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

NCT05880212 | Recruiting DMC

• 1 other identifier: HEC22334
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Low-back Pain

Keywords

Chronic low back pain; Physiotherapy; Usual care; STOPS; Implementation trial; Bangladesh; Physiotherapist

Outcome Measures

Primary Outcomes (3)

• Activity limitation

  Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.

  Primary endpoint will be 26 weeks post-enrolment.

• Back Pain Intensity

  0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.

  Primary endpoint will be 26 weeks post-enrolment.

• Leg Pain Intensity

  0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.

  Primary endpoint will be 26 weeks post-enrolment.

Secondary Outcomes (22)

• Work hours missed

  5, 10, and 26-weeks post enrolment

• Work productivity

  5, 10, and 26-weeks post enrolment

• Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)

  5, 10, and 26-weeks post enrolment

• Health-related quality of life (EQ-5D-5L)

  5, 10, and 26-weeks post enrolment

• Depression, Anxiety and Stress Scales - DASS-21

  5, 10, and 26-weeks post enrolment

Other Outcomes (9)

• Physiotherapists' self-confidence in low back pain management

  After 26 weeks of phases 1 and 3. After the completion of phase 2 training

• Physiotherapists' implementation behaviour

  At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.

• Physiotherapists' experiences

  At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.

Study Arms (2)

Usual physiotherapy care

ACTIVE COMPARATOR

One physiotherapy assessment, 10 x 45-minute sessions of usual care physiotherapy (over a 10-week period), plus 1 x 45-minute followup session of usual care physiotherapy after 6 months.

Other: Usual physiotherapy care

Individualized (STOPS) physiotherapy

EXPERIMENTAL

One physiotherapy assessment, 10 x 45-minute sessions of individualised (STOPS) physiotherapy (weekly for 10 weeks), plus 1 x 45-minute followup session of individualised (STOPS) physiotherapy after 6 months.

Other: Individualized (STOPS) physiotherapy

Interventions

Usual physiotherapy care OTHER

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.

Usual physiotherapy care

Individualized (STOPS) physiotherapy OTHER

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.

Individualized (STOPS) physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC): collaborator
• Mohammad Ali: lead
• La Trobe University: collaborator

Study Sites (1)

Uttara Adhunik Medical College Hospital

Dhaka, Uttara, 1230, Bangladesh

RECRUITING

Related Publications (1)

• Ali M, Ford JJ, Hossain A, Danazumi MS, Hahne AJ. Implementing individualised physiotherapy using the Specific Treatment of Problems of the Spine (STOPS) approach for chronic low back pain in Bangladesh: Protocol for a prospective sequential comparison clinical trial. Contemp Clin Trials. 2025 Jul;154:107960. doi: 10.1016/j.cct.2025.107960. Epub 2025 May 21.

  PMID: 40409680 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mohammad Ali, MPhil

  Uttara Adhunik Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Ali, MPhil

CONTACT

(88) 01715043533; mohammad.ali@latrobe.edu.au

Andrew Hahne, PhD

CONTACT

61394793392; A.Hahne@latrobe.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the trial hypothesis and knowledge of the fact that two treatment options are being compared.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD researcher

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 30, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 12 months of the study completion date
• Access Criteria: Other researchers can request access to the data they require for a specific purpose. A data sharing agreement will need to be signed outlining the nature and restrictions on the use of the data for a specific purpose. Requests can be sent to the Investigators, or the La Trobe University Human Ethics Committee.

Locations

BA (1)