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NCT Number: NCT05880212

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

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?

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uttara Adhunik Medical College Hospital

Dhaka, Uttara, 1230, Bangladesh

Location status: Recruiting

Location contact

Mohammad Ali, MPhil

CONTACT

[email protected]

8801715043533

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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 criteria

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Activity limitation

    Time frame: Primary endpoint will be 26 weeks post-enrolment.

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

  2. Back Pain Intensity

    Time frame: Primary endpoint will be 26 weeks post-enrolment.

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

  3. Leg Pain Intensity

    Time frame: Primary endpoint will be 26 weeks post-enrolment.

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

Secondary outcomes

  1. Work hours missed

    Time frame: 5, 10, and 26-weeks post enrolment

    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)

  2. Work productivity

    Time frame: 5, 10, and 26-weeks post enrolment

    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.

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

    Time frame: 5, 10, and 26-weeks post enrolment

    The total score ranges between 1 and 100, with higher scores indicating a worse outcome.

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

    Time frame: 5, 10, and 26-weeks post enrolment

    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. Depression, Anxiety and Stress Scales - DASS-21

    Time frame: 5, 10, and 26-weeks post enrolment

    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.

  6. Pain Self Efficacy

    Time frame: 5, 10, and 26-weeks post enrolment

    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).

  7. Pain Catastrophizing

    Time frame: 5, 10, and 26-weeks post enrolment

    Pain Catastrophizing Scale (PCS). The score ranges from 0 to 52. A higher score denotes more catastrophizing (worse outcome)

  8. Sleep quality

    Time frame: 5, 10, and 26-weeks post enrolment

    Insomnia Severity Index (ISI-7). Score ranges from 0 to 28, with higher scores indicating worse sleep quality (worse outcome)

  9. Central Sensitisation symptoms

    Time frame: 5, 10, and 26-weeks post enrolment

    Central Sensitisation Inventory (CSI-9). Score ranges from 0 to 36, with higher scores indicating more symptoms indicative of potential central sensitisation

  10. Inflammatory symptoms

    Time frame: 5, 10, and 26-weeks post enrolment

    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)

  11. Treatment Credibility

    Time frame: 5, 10, and 26-weeks post enrolment

    Treatment credibility questionnaire. Scored 0-10. A higher score indicates greater confidence in the treatment (better outcome).

  12. Healthcare utilization

    Time frame: 5, 10, and 26-weeks post enrolment

    A patient diary will be used to track healthcare service utilization, imaging, and medication. These are recorded descriptively.

  13. Participant adherence with treatment

    Time frame: 5, 10, and 26-weeks post enrolment

    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).

  14. Global rating of change

    Time frame: 5, 10, and 26-weeks post enrolment

    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.

  15. Satisfaction with treatment

    Time frame: 5, 10, and 26-weeks post enrolment

    Participants will rate their satisfaction with physiotherapy treatment on a 5-point Likert scale, with ratings from "very satisfied" to "very dissatisfied".

  16. Adverse events

    Time frame: 5, 10, and 26-weeks post enrolment

    Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.

  17. Qualitative interviews

    Time frame: 10 weeks post-enrolment

    Semi-structured interviews relating to the patient's experiences with the Usual care and STOPS physiotherapy will be conducted.

  18. Pain severity

    Time frame: 5, 10, and 26-weeks post enrolment

    Brief Pain Inventory. Average of the four pain severity items, scores range from 0-10, lower scores indicate less pain severity.

  19. Pain interference

    Time frame: 5, 10, and 26-weeks post enrolment

    Brief Pain Inventory. Average of the seven pain interference items, scores range from 0-10, lower scores indicate less pain interference.

  20. Back Pain Intensity

    Time frame: 5, 10 and 52-weeks post enrolment

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

  21. Leg Pain Intensity

    Time frame: 5, 10 and 52-weeks post enrolment

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

  22. Activity limitation

    Time frame: 5, 10 and 52-weeks post enrolment

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

Other outcomes

  1. Physiotherapists' self-confidence in low back pain management

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

    Practitioner Self-Confidence Scale. Scored 4-20 where higher scores indicate worse self-confidence towards clinical management of low back pain (worse outcome).

  2. Physiotherapists' implementation behaviour

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

    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)

  3. Physiotherapists' experiences

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

    Physiotherapists' experiences with implementing usual care and STOPS physiotherapy will be assessed via qualitative semi-structured interviews.

  4. Treatment effect modifier: Pain type

    Time frame: Effect modifiers are measured at baseline, and their potential impact determined on outcomes at week 5, 10, and 26

    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.

  5. Treatment effect modifier: Disability

    Time frame: Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26

    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.

  6. Treatment effect modifier: Prognosis (Orebro short-form screening questionnaire)

    Time frame: Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26

    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.

  7. Treatment effect modifier: Duration of symptoms

    Time frame: Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26

    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.

  8. Mediator analysis: pain self-efficacy

    Time frame: Change in pain self-efficacy from baseline to 10 weeks and 26 weeks

    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

  9. Mediator analysis: inflammatory symptoms

    Time frame: Change in clinical inflammation score from baseline to 10 weeks and 26 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Hahne, PhD

CONTACT

[email protected]

61394793392

Mohammad Ali, MPhil

CONTACT

[email protected]

(88) 01715043533

Sponsors and collaborators

Lead sponsor

Mohammad Ali

Other

Collaborators

  • Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC)
  • La Trobe University

Registry information

Official study title

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

Acronym: STOPS-Bangla

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 30, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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