Implementation of the Specific Treatment Of Problems of the Spine Approach in Bangladesh (STOPS-Bangla)

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

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?

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Usual physiotherapy care; Other: Individualized (STOPS) physiotherapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Ali, MPhil; Phone Number: (88) 01715043533; Email: mohammad.ali@latrobe.edu.au
• Study Contact Backup: Name: Andrew Hahne, PhD; Phone Number: 61394793392; Email: A.Hahne@latrobe.edu.au

Study Locations

• Bangladesh
  • Uttara
    • Dhaka, Uttara, Bangladesh, 1230
      • Recruiting
      • Uttara Adhunik Medical College Hospital
      • Contact: Mohammad Ali, MPhil; Phone Number: 8801715043533; Email: mohammad.ali@latrobe.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual physiotherapy care; 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; 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.
Experimental: Individualized (STOPS) physiotherapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work hours missed	Number of work/housework hours missed during the past 7 days (continuous scale from 0 to 50). Lower score indicated less hours missed (better outcome)	5, 10, and 26-weeks post enrolment
Work productivity	0-10 numerical rating scale of how much pain affected work productivity in the last 7 days. Score 0-10, with lower scores indicating less interference with work productivity.	5, 10, and 26-weeks post enrolment
Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)	The total score ranges between 1 and 100, with higher scores indicating a worse outcome.	5, 10, and 26-weeks post enrolment
Health-related quality of life (EQ-5D-5L)	Utility scores will be calculated from the EuroQOL-5D-5L, with scores ranging from -0.148 to 0.949 (higher scores indicate better quality of life)	5, 10, and 26-weeks post enrolment
Depression, Anxiety and Stress Scales - DASS-21	The DASS-21 measures symptoms of stress, anxiety and depression, with a total composite score ranging from 0-63 with higher scores indicating more severe symptoms of distress.	5, 10, and 26-weeks post enrolment
Pain Self Efficacy	Pain Self Efficacy Questionnaire (PSEQ). A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain (better outcome).	5, 10, and 26-weeks post enrolment
Pain Catastrophizing	Pain Catastrophizing Scale (PCS). The score ranges from 0 to 52. A higher score denotes more catastrophizing (worse outcome)	5, 10, and 26-weeks post enrolment
Sleep quality	Insomnia Severity Index (ISI-7). Score ranges from 0 to 28, with higher scores indicating worse sleep quality (worse outcome)	5, 10, and 26-weeks post enrolment
Central Sensitisation symptoms	Central Sensitisation Inventory (CSI-9). Score ranges from 0 to 36, with higher scores indicating more symptoms indicative of potential central sensitisation	5, 10, and 26-weeks post enrolment
Inflammatory symptoms	The 4-item clinical inflammation score will measure low back-related inflammatory symptoms. Scores range from 0 to 4, with higher scores indicating more inflammatory symptoms (worse outcome)	5, 10, and 26-weeks post enrolment
Treatment Credibility	Treatment credibility questionnaire. Scored 0-10. A higher score indicates greater confidence in the treatment (better outcome).	5, 10, and 26-weeks post enrolment
Healthcare utilization	A patient diary will be used to track healthcare service utilization, imaging, and medication. These are recorded descriptively.	5, 10, and 26-weeks post enrolment
Participant adherence with treatment	Participant adherence with treatment will be determined via a self-administered 0-10 rating scale, with higher scores indicating greater adherence with treatment (better outcome).	5, 10, and 26-weeks post enrolment
Global rating of change	Global change will be measured on a 7-point scale ranging from "very much worse" to "very much better". Scores range from 1-7, with a higher score indicating greater improvement.	5, 10, and 26-weeks post enrolment
Satisfaction with treatment	Participants will rate their satisfaction with physiotherapy treatment on a 5-point Likert scale, with ratings from "very satisfied" to "very dissatisfied".	5, 10, and 26-weeks post enrolment
Adverse events	Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.	5, 10, and 26-weeks post enrolment
Qualitative interviews	Semi-structured interviews relating to the patient's experiences with the Usual care and STOPS physiotherapy will be conducted.	10 weeks post-enrolment
Pain severity	Brief Pain Inventory. Average of the four pain severity items, scores range from 0-10, lower scores indicate less pain severity.	5, 10, and 26-weeks post enrolment
Pain interference	Brief Pain Inventory. Average of the seven pain interference items, scores range from 0-10, lower scores indicate less pain interference.	5, 10, and 26-weeks post enrolment
Back Pain Intensity	0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.	5, 10 and 52-weeks post enrolment
Leg Pain Intensity	0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.	5, 10 and 52-weeks post enrolment
Activity limitation	Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.	5, 10 and 52-weeks post enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiotherapists' self-confidence in low back pain management	Practitioner Self-Confidence Scale. Scored 4-20 where higher scores indicate worse self-confidence towards clinical management of low back pain (worse outcome).	After 26 weeks of phases 1 and 3. After the completion of phase 2 training
Physiotherapists' implementation behaviour	Implementation behaviour questionnaire (DIBQ-t) will be used. The questionnaire includes 26 items, with each item rated on a 5-point Likert scale. A total score from 0-100 is derived, with higher scores indicate stronger implementation behaviours. (better outcome)	At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.
Physiotherapists' experiences	Physiotherapists' experiences with implementing usual care and STOPS physiotherapy will be assessed via qualitative semi-structured interviews.	At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.
Treatment effect modifier: Pain type	Pain type (categorised as nociceptive, neuropathic, or nociplastic dominant pain) is being pre-specified as a potential treatment effect modifier on the primary outcome measures. It is hypothesised that patients with neuropathic pain will derive additional benefit of STOPS physiotherapy over usual care.	Effect modifiers are measured at baseline, and their potential impact determined on outcomes at week 5, 10, and 26
Treatment effect modifier: Disability	Disability (measured using the Oswestry Disability Questionnaire - score from 0-100%) is being pre-specified as a potential treatment effect modifier on the primary outcome measures. It is hypothesised that patients with higher disability scores will derive additional benefit from STOPS physiotherapy over usual care.	Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
Treatment effect modifier: Prognosis (Orebro short-form screening questionnaire)	Prognosis (measured on the 0-100 Orebro short-form) is being pre-specified as a potential treatment effect modifier on the primary outcome measures. It is hypothesised that patients with higher Orebro scores will derive additional benefit from STOPS physiotherapy over usual care.	Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
Treatment effect modifier: Duration of symptoms	Duration of symptoms (measured on a continuous scale in weeks) is being pre-specified as a potential treatment effect modifier on the primary outcome measures. It is hypothesised that patients with higher duration of symptoms will derive additional benefit from STOPS physiotherapy over usual care.	Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
Mediator analysis: pain self-efficacy	Mediator analyses will determine the potential mechanisms of action for the individualised (STOPS) physiotherapy, with the following potential mediator identified a-priori: Does pain self-efficacy (measured on the 0-60 pain self-efficacy scale) mediate the effect of individualised physiotherapy on primary outcomes	Change in pain self-efficacy from baseline to 10 weeks and 26 weeks
Mediator analysis: inflammatory symptoms	Mediator analyses will determine the potential mechanisms of action for the individualised (STOPS) physiotherapy, with the following potential mediator identified a-priori: Does inflammation (measure on the 0-4 clinical inflammation scale) mediate the effect of individualised physiotherapy on primary outcomes	Change in clinical inflammation score from baseline to 10 weeks and 26 weeks

Collaborators and Investigators

• Sponsor: Mohammad Ali
• Collaborators: La Trobe University; Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC)
• Investigators: Principal Investigator: Mohammad Ali, MPhil, Uttara Adhunik Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Physiotherapy; Chronic low back pain; Bangladesh; Physiotherapist; Usual care; STOPS; Implementation trial
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HEC22334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data collected during the trial will be available upon specific request t the researchers.
• IPD Sharing Time Frame: Within 12 months of the study completion date
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No