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

Chronic Low-back Pain Clinical Trial

— STOPS-Bangla  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880212
• Other study ID #: HEC22334
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: Uttara Adhunik Medical College
• Contact: Mohammad Ali, MPhil
• Phone: (88) 01715043533
• Email: mohammad.ali[@]latrobe.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: June 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Bangladesh	Uttara Adhunik Medical College Hospital	Dhaka	Uttara

Sponsors (3)

Lead Sponsor	Collaborator
Mohammad Ali	Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC), La Trobe University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.
Other	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.
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Activity limitation	Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.	Primary endpoint will be 26 weeks post-enrolment.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.	5, 10, and 26-weeks post enrolment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Activity limitation	Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.	5, 10 and 52-weeks post enrolment