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| Name | Class |
|---|---|
| Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC) | UNKNOWN |
| La Trobe University | OTHER |
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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Ali, MPhil | Contact | (88) 01715043533 | mohammad.ali@latrobe.edu.au | |
| Andrew Hahne, PhD | Contact | 61394793392 | A.Hahne@latrobe.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Mohammad Ali, MPhil | Uttara Adhunik Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uttara Adhunik Medical College Hospital | Recruiting | Dhaka | Uttara | 1230 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409680 | Derived | 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. |
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De-identified participant data collected during the trial will be available upon specific request t the researchers.
Within 12 months of the study completion date
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.
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Participants will be blinded to the trial hypothesis and knowledge of the fact that two treatment options are being compared.
| 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. |
|
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 |
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 |