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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05880212
Other study ID # HEC22334
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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