Chronic Low-back PainSTOPS-BanglaNCT05880212
Implementation of the Specific Treatment Of Problems of the Spine Approach in Bangladesh
A study testing Usual physiotherapy care and Individualized (STOPS) physiotherapy in people with Chronic Low-back Pain, run by Mohammad Ali at 1 site in Bangladesh.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Usual physiotherapy care and Individualized (STOPS) physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Aug 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Uttara Adhunik Medical College Hospital
Dhaka, Uttara, 1230
Mohammad Ali, MPhil, 8801715043533, mohammad.ali@latrobe.edu.au
About this study
Official title: Implementation of the Specific Treatment Of Problems of the Spine (STOPS) Approach in Bangladesh: A Prospective Sequential Comparison
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?
Read the 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).
- Conditions
- Chronic Low-back Pain
- Being tested
- Usual physiotherapy care, Individualized (STOPS) physiotherapy
- Keywords
- Chronic low back pain, Physiotherapy, Usual care, STOPS, Implementation trial, Bangladesh, Physiotherapist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual physiotherapy careOther
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) physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Usual physiotherapy care |
| 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. Receives: Other: Individualized (STOPS) physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity limitation
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Measured: 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.
Measured: 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.
Measured: Primary endpoint will be 26 weeks post-enrolment.
Secondary outcomes (22)
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)
Measured: 5, 10, and 26-weeks post enrolment
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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".
Measured: 5, 10, and 26-weeks post enrolment
Adverse events
Adverse effects events (harmful or unpleasant) will be recorded descriptively in the therapists clinical notes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5, 10 and 52-weeks post enrolment
Activity limitation
Oswestry Disability Questionnaire (ODI). Measured from 0-100% with lower scores meaning less disability.
Measured: 5, 10 and 52-weeks post enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Aug 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC), La Trobe University
- Responsible party
- Sponsor-investigator, Mohammad Ali, Uttara Adhunik Medical College
- Investigators
- Mohammad Ali, MPhil, Principal investigator, Uttara Adhunik Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880212
- Sponsor's protocol ID
- HEC22334
- Acronym
- STOPS-Bangla
- Status last verified
- Apr 2026
- First submitted
- 4 May 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data collected during the trial will be available upon specific request t the researchers.
Publications
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.
PubMed 40409680
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Specific Treatment Of Problems of the Spine (STOPS) Approach in Bangladesh: A Prospective Sequential Comparison
- ClinicalTrials.gov ID
- NCT05880212
- Acronym / sponsor ID
- STOPS-Bangla / HEC22334
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic low back pain, Physiotherapy, Usual care, STOPS, Implementation trial, Bangladesh, Physiotherapist
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Mohammad AliUniversity, hospital or other
- Collaborators
- Hasna Hena Pain, Physiotherapy and Public Health Research Center (HPRC), La Trobe University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual physiotherapy care | Active comparator | Other: Usual physiotherapy careOne 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 | Other: Individualized (STOPS) physiotherapyOne 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- A primary complaint of either:
- or
- 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)
Key exclusion criteria (12 listed)
- Not willing to participate in the study for all 3 phases.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual physiotherapy careIn 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. | Other | Usual physiotherapy care |
| Individualized (STOPS) physiotherapyIn 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. | Other | Individualized (STOPS) physiotherapy |
Primary outcome
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.
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.
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.
22 secondary outcomes
Work hours missed
Time frame: 5, 10, and 26-weeks post enrolment
Work productivity
Time frame: 5, 10, and 26-weeks post enrolment
Short-Form Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-SF)
Time frame: 5, 10, and 26-weeks post enrolment
Health-related quality of life (EQ-5D-5L)
Time frame: 5, 10, and 26-weeks post enrolment
Depression, Anxiety and Stress Scales - DASS-21
Time frame: 5, 10, and 26-weeks post enrolment
Pain Self Efficacy
Time frame: 5, 10, and 26-weeks post enrolment
Pain Catastrophizing
Time frame: 5, 10, and 26-weeks post enrolment
Sleep quality
Time frame: 5, 10, and 26-weeks post enrolment
Central Sensitisation symptoms
Time frame: 5, 10, and 26-weeks post enrolment
Inflammatory symptoms
Time frame: 5, 10, and 26-weeks post enrolment
Treatment Credibility
Time frame: 5, 10, and 26-weeks post enrolment
Healthcare utilization
Time frame: 5, 10, and 26-weeks post enrolment
Participant adherence with treatment
Time frame: 5, 10, and 26-weeks post enrolment
Global rating of change
Time frame: 5, 10, and 26-weeks post enrolment
Satisfaction with treatment
Time frame: 5, 10, and 26-weeks post enrolment
Adverse events
Time frame: 5, 10, and 26-weeks post enrolment
Qualitative interviews
Time frame: 10 weeks post-enrolment
Pain severity
Time frame: 5, 10, and 26-weeks post enrolment
Pain interference
Time frame: 5, 10, and 26-weeks post enrolment
Back Pain Intensity
Time frame: 5, 10 and 52-weeks post enrolment
Leg Pain Intensity
Time frame: 5, 10 and 52-weeks post enrolment
Activity limitation
Time frame: 5, 10 and 52-weeks post enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 40409680Ali 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.
- Individual participant dataSharing planned: Yes. De-identified participant data collected during the trial will be available upon specific request t the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Ali, MPhil principal investigator
Uttara Adhunik Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual physiotherapy care and Individualized (STOPS) physiotherapy in people with Chronic Low-back Pain, run by Mohammad Ali at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Ali, MPhil ((88) 01715043533, mohammad.ali@latrobe.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity limitation (time frame: Primary endpoint will be 26 weeks post-enrolment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.