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CTRI Number  CTRI/2024/08/072259 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two physiotherapy interventions for Low Back Disorders in India: A Randomized Controlled Trial 
Scientific Title of Study   Individualized physiotherapy versus usual care (STOPS trial) for Low Back Disorders in India: A Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavitha Raja 
Designation  Professor and Principal 
Affiliation  JSS College of Physiotehrapy 
Address  Room number 01, Department of Community Health Sciences, JSS College of Physiotherapy, JSS Hospital campus

Mysore
KARNATAKA
570004
India 
Phone  9048368029  
Fax    
Email  kavitharaja_jsscpt@jssonline.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavitha Raja 
Designation  Professor and Principal 
Affiliation  JSS College of Physiotehrapy 
Address  Room number 01, Department of Community Health Sciences, JSS College of Physiotherapy, JSS Hospital campus

Mysore
KARNATAKA
570004
India 
Phone  9048368029  
Fax    
Email  kavitharaja_jsscpt@jssonline.org  
 
Details of Contact Person
Public Query  
Name  Dr Kavitha Raja 
Designation  Professor and Principal 
Affiliation  JSS College of Physiotehrapy 
Address  Room number 01, Department of Community Health Sciences, JSS College of Physiotherapy, JSS Hospital campus

Mysore
KARNATAKA
570004
India 
Phone  9048368029  
Fax    
Email  kavitharaja_jsscpt@jssonline.org  
 
Source of Monetary or Material Support  
JSS College of Physiotherapy and department of Physiotherapy, JSS Hospital, MG Road, Mysuru, 570004 
 
Primary Sponsor  
Name  Dr Kavitha Raja 
Address  Room number 01, Department of Community Health Sciences, JSS College of Physiotherapy, JSS Hospital campus 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Andrew Hahne  La Trobe University, Plenty Road, Kingsbury Dr, Bundoora VIC 3086, Australia 
Dr Jon Ford  La Trobe University, Plenty Road, Kingsbury Dr, Bundoora VIC 3086, Australia 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavitha Raja  JSS Hospital, Mysuru  Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA 		 9686677220

kavitharaja_jsscpt@jssonline.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Individualised Physiotherapy based on the Specific Treatment Of Problems of the Spine (STOPS) approach  Description: Participants will receive individualised physiotherapy in accordance with the Specific Treatment of Problems of the Spine (STOPS) approach modified for persistent low back pain. Treatment will be individualised 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 individualised education/advice, exercise, manual therapy, activity modification/facilitation , goal setting, motor control optimisation, cognitive-behavioural strategies, inflammation management, painmanagement strategies, sleep management strategies, work management strategies, and relaxation approaches. Dosage and duration: Participants will receive 10 x 45-minute physiotherapy sessions over a 10-week period, plus an 11th session at 26 weeks post-randomisation to review progress. 
Comparator Agent  Usual physiotherapy care  Physiotherapists will provide treatment for participants with low back pain in accordance with their current standard physiotherapy practice. Physiotherapists will be free to choose the treatment approach they wish to. Dosage and duration: Participants will receive 10 x 45-minute physiotherapy sessions over a 10-week period, plus an 11th session at 26 weeks post-randomisation to review progress. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. A primary complaint of either:
a. 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
b. referred leg pain, defined as predominately unilateral posterior leg pain
extending below the knee, or anterior thigh pain, with or without back pain (disc
herniation with associated radiculopathy subgroup only)
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, Kannada or Hindi languages 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. 
 
ExclusionCriteria 
Details  1. Active cancer under current treatment
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
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
6. A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low
severity
7. Minimal activity limitation, evidenced by a baseline ability to 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. Already received more than 5 sessions of physiotherapy with any of the treating
physiotherapists before enrolment, as these therapists are likely to use many
components of the trial treatment protocol on their usual client caseload
9. Inability to walk safely, such as severe foot drop causing regular tripping, as the
interventions in the trial include walking for most participants
10. Planned absence of more than one week during the treatment period (such as
overseas holidays) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Oswestry Disability Index V2.1 with “sex life” question replaced
by a “work/housework” question
 		 0, 5, 10, 26 and 52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Global rating of change scale (7-point Likert scale)
2. Satisfaction with treatment (5-point Likert scale)
3. Treatment Credibility Questionnaire
4. Healthcare utilisation
5. Adverse events 		 5th, 10th and 26th weeks 
6. Interference with work or housework in the past week (5-
point Likert scale) and the number of hours missed at work in
past week.
7. Örebro Musculoskeletal Pain Screening Questionnaire
(ÖMPSQ-SF)
8. Quality of life (EuroQol-5D-5L)
9. Pain Catastrophizing Scale (PCS)
10. Depression Anxiety and Stress Scale (DASS-21)
11. Pain Self-Efficacy questionnaire (PSEQ)
12. Pain Catastrophizing Scale (PCS)
13. Insomnia Severity Index (ISI)
14. Central Sensitisation Inventory (CSI)
15. Clinical inflammation score
16. Brief pain inventory  		 At baseline, 5th, 10th, and 26th week 
17. Compliance with treatment  5th, 10th, 26th and 52nd weeks 
18. Resting state and task based functional MRI (only from a cohort of the sample)  Baseline and 11th week 
19. Qualitative interviews  At the end of treatment trial (10th week)  
20. Treatment effect modifiers and mediators.

The following potential treatment effect modifiers are identified a-priori:
a) Pain type (nociceptive, neuropathic or nociplastic)
b) Disability (Oswestry)
c) Prognosis (Orebro)
d) Duration of pain
The following potential mediators identified a-priori:
1) Does self-efficacy mediate the effect of individualized physiotherapy on disability (Oswestry)?
2) Does inflammation (clinical signs of inflammation scale) mediate the effect of individualized physiotherapy on pain severity (NDI) and disability (Oswestry).
Subsequently, a data-driven approach will be employed to identify other mediators and effect modifiers in an exploratory analysis. 		 10th week and 26th week 
21. Average back pain intensity over the last week, measured on the 0-10 numerical pain rating scale
22. Average leg pain intensity over the last week, measured on the 0-10 numerical pain rating scale 		 0, 5, 10, 26 and 52 weeks 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kavitharaja62@gmail.com].

  6. For how long will this data be available start date provided 26-06-2026 and end date provided 25-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - N/A
Brief Summary   People with low-back pain (LBP) commonly have poor outcomes. This is partly because LBP can be a complex condition where a single treatment approach may not achieve optimal outcomes for all patients. The application of generic treatment may also be a factor in the mixed results of randomised controlled trials (RCTs) that evaluated physiotherapy. The Specific Treatment of Problems of the Spine (STOPS) trial has been previously conducted across multiple primary care physiotherapy practices in Melbourne, Australia, demonstrating clinically important improvements in pain and disability compared to guideline-based treatment. A clinical trial to evaluate the STOPS approach in Asia is planned to commence at JSS College of Physiotherapy Clinic, Mysore India.  
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