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

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Usual physiotherapy care
Individualized (STOPS) physiotherapy
Sponsored by
Mohammad Ali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic low back pain, Physiotherapy, Usual care, STOPS, Implementation trial, Bangladesh, Physiotherapist

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Uttara Adhunik Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual physiotherapy care

Individualized (STOPS) physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Activity limitation
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Back Pain Intensity
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Leg Pain Intensity
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.

Secondary Outcome Measures

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)
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.
Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)
The total score ranges between 1 and 100, with higher scores indicating a worse outcome.
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)
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.
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).
Pain Catastrophizing
Pain Catastrophizing Scale (PCS). The score ranges from 0 to 52. A higher score denotes more catastrophizing (worse outcome)
Sleep quality
Insomnia Severity Index (ISI-7). Score ranges from 0 to 28, with higher scores indicating worse sleep quality (worse outcome)
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
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)
Treatment Credibility
Treatment credibility questionnaire. Scored 0-10. A higher score indicates greater confidence in the treatment (better outcome).
Healthcare utilization
A patient diary will be used to track healthcare service utilization, imaging, and medication. These are recorded descriptively.
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).
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.
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".
Adverse events
Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.
Qualitative interviews
Semi-structured interviews relating to the patient's experiences with the Usual care and STOPS physiotherapy will be conducted.
Pain severity
Brief Pain Inventory. Average of the four pain severity items, scores range from 0-10, lower scores indicate less pain severity.
Pain interference
Brief Pain Inventory. Average of the seven pain interference items, scores range from 0-10, lower scores indicate less pain interference.
Back Pain Intensity
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Leg Pain Intensity
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Activity limitation
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.

Full Information

First Posted
May 4, 2023
Last Updated
May 18, 2023
Sponsor
Mohammad Ali
Collaborators
Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC), La Trobe University
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1. Study Identification

Unique Protocol Identification Number
NCT05880212
Brief Title
Implementation of the Specific Treatment Of Problems of the Spine Approach in Bangladesh
Acronym
STOPS-Bangla
Official Title
Implementation of the Specific Treatment Of Problems of the Spine (STOPS) Approach in Bangladesh: A Prospective Sequential Comparison
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammad Ali
Collaborators
Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC), La Trobe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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?
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic low back pain, Physiotherapy, Usual care, STOPS, Implementation trial, Bangladesh, Physiotherapist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will be blinded to the trial hypothesis and knowledge of the fact that two treatment options are being compared.
Allocation
Non-Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual physiotherapy care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Individualized (STOPS) physiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual physiotherapy care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individualized (STOPS) physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Activity limitation
Description
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Time Frame
Primary endpoint will be 26 weeks post-enrolment.
Title
Back Pain Intensity
Description
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Time Frame
Primary endpoint will be 26 weeks post-enrolment.
Title
Leg Pain Intensity
Description
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Time Frame
Primary endpoint will be 26 weeks post-enrolment.
Secondary Outcome Measure Information:
Title
Work hours missed
Description
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)
Time Frame
5, 10, and 26-weeks post enrolment
Title
Work productivity
Description
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.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)
Description
The total score ranges between 1 and 100, with higher scores indicating a worse outcome.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Health-related quality of life (EQ-5D-5L)
Description
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)
Time Frame
5, 10, and 26-weeks post enrolment
Title
Depression, Anxiety and Stress Scales - DASS-21
Description
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.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Pain Self Efficacy
Description
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).
Time Frame
5, 10, and 26-weeks post enrolment
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale (PCS). The score ranges from 0 to 52. A higher score denotes more catastrophizing (worse outcome)
Time Frame
5, 10, and 26-weeks post enrolment
Title
Sleep quality
Description
Insomnia Severity Index (ISI-7). Score ranges from 0 to 28, with higher scores indicating worse sleep quality (worse outcome)
Time Frame
5, 10, and 26-weeks post enrolment
Title
Central Sensitisation symptoms
Description
Central Sensitisation Inventory (CSI-9). Score ranges from 0 to 36, with higher scores indicating more symptoms indicative of potential central sensitisation
Time Frame
5, 10, and 26-weeks post enrolment
Title
Inflammatory symptoms
Description
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)
Time Frame
5, 10, and 26-weeks post enrolment
Title
Treatment Credibility
Description
Treatment credibility questionnaire. Scored 0-10. A higher score indicates greater confidence in the treatment (better outcome).
Time Frame
5, 10, and 26-weeks post enrolment
Title
Healthcare utilization
Description
A patient diary will be used to track healthcare service utilization, imaging, and medication. These are recorded descriptively.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Participant adherence with treatment
Description
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).
Time Frame
5, 10, and 26-weeks post enrolment
Title
Global rating of change
Description
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.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Satisfaction with treatment
Description
Participants will rate their satisfaction with physiotherapy treatment on a 5-point Likert scale, with ratings from "very satisfied" to "very dissatisfied".
Time Frame
5, 10, and 26-weeks post enrolment
Title
Adverse events
Description
Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Qualitative interviews
Description
Semi-structured interviews relating to the patient's experiences with the Usual care and STOPS physiotherapy will be conducted.
Time Frame
10 weeks post-enrolment
Title
Pain severity
Description
Brief Pain Inventory. Average of the four pain severity items, scores range from 0-10, lower scores indicate less pain severity.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Pain interference
Description
Brief Pain Inventory. Average of the seven pain interference items, scores range from 0-10, lower scores indicate less pain interference.
Time Frame
5, 10, and 26-weeks post enrolment
Title
Back Pain Intensity
Description
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Time Frame
5, 10 and 52-weeks post enrolment
Title
Leg Pain Intensity
Description
0-10 numerical pain rating scale, average over the previous week. Lower scores indicate a better outcome.
Time Frame
5, 10 and 52-weeks post enrolment
Title
Activity limitation
Description
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Time Frame
5, 10 and 52-weeks post enrolment
Other Pre-specified Outcome Measures:
Title
Physiotherapists' self-confidence in low back pain management
Description
Practitioner Self-Confidence Scale. Scored 4-20 where higher scores indicate worse self-confidence towards clinical management of low back pain (worse outcome).
Time Frame
After 26 weeks of phases 1 and 3. After the completion of phase 2 training
Title
Physiotherapists' implementation behaviour
Description
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)
Time Frame
At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.
Title
Physiotherapists' experiences
Description
Physiotherapists' experiences with implementing usual care and STOPS physiotherapy will be assessed via qualitative semi-structured interviews.
Time Frame
At the end treating the usual care group, and again at the end of treating the individualised (STOPS) physiotherapy group.
Title
Treatment effect modifier: Pain type
Description
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.
Time Frame
Effect modifiers are measured at baseline, and their potential impact determined on outcomes at week 5, 10, and 26
Title
Treatment effect modifier: Disability
Description
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.
Time Frame
Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
Title
Treatment effect modifier: Prognosis (Orebro short-form screening questionnaire)
Description
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.
Time Frame
Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
Title
Treatment effect modifier: Duration of symptoms
Description
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.
Time Frame
Effect modifiers are measured at baseline, and their potential impact determined on primary outcomes at week 5, 10, and 26
Title
Mediator analysis: pain self-efficacy
Description
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
Time Frame
Change in pain self-efficacy from baseline to 10 weeks and 26 weeks
Title
Mediator analysis: inflammatory symptoms
Description
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
Time Frame
Change in clinical inflammation score from baseline to 10 weeks and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Ali, MPhil
Phone
(88) 01715043533
Email
mohammad.ali@latrobe.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Hahne, PhD
Phone
61394793392
Email
A.Hahne@latrobe.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Ali, MPhil
Organizational Affiliation
Uttara Adhunik Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uttara Adhunik Medical College Hospital
City
Dhaka
State/Province
Uttara
ZIP/Postal Code
1230
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Ali, MPhil
Phone
8801715043533
Email
mohammad.ali@latrobe.edu.au

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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