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CTRI Number  CTRI/2025/12/099774 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Research Study to Compare Different Conservative Treatment Methods including Physiotherapy, Osteopathy and Manual Therapy Methods for Patients having Lower back pain (Lumbar Canal Stenosis) 
Scientific Title of Study   A Comparative Study Of Modified Manual Therapy Approach, Integrated Osteopathic Approach And Conventional Physiotherapy In Lumbar Canal Stenosis A Randomised Control 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  Madhulika Sethiya 
Designation  PhD Scholar 
Affiliation  Sardar Bhagwan Singh University 
Address  Department Of Physiotherapy, Sardar Bhagwan Singh University New Campus, Near Bangi Pulia, Balawala, Dehradun

Dehradun
UTTARANCHAL
248008
India 
Phone  9926412140  
Fax    
Email  madhulikasethiya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dr. Maneesh Arora 
Designation  Professor and Dean Department of Physiotherapy 
Affiliation  Sardar Bhagwan Singh University 
Address  Dean Office, Department Of Physiotherapy, Sardar Bhagwan Singh University New Campus, Near Bangi Pulia, Balawala, Dehradun

Dehradun
UTTARANCHAL
248008
India 
Phone  9412052921  
Fax    
Email  msharora@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Madhulika Sethiya 
Designation  PhD Scholar 
Affiliation  Sardar Bhagwan Singh University 
Address  Department Of Physiotherapy, Sardar Bhagwan Singh University New Campus, Near Bangi Pulia, Balawala, Dehradun

Dehradun
UTTARANCHAL
248008
India 
Phone  9926412140  
Fax    
Email  madhulikasethiya@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sardar Bhagwan Singh University 
Address  PhD Scholar, Department of Physiotherapy, SBS University, Balawal, Dehradun 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof R Arunmozhi  Sardar Bhagwan Singh University  Department of Physiotherapy, SBS University, Balawala
Dehradun
UTTARANCHAL 		 7895617031

rmozhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (IRB) of Sardar Bhagwan Singh University  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  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy   TENS, Moist Heat pack, Lower back exercises. Duration: 45minutes of session. Frequency: Thrice a Week, Total of 18 sessions in six weeks. 
Intervention  Integrated Osteopathic Approach  Lumbo-sacral release, sacral release and sacral rhythm and Dural mobilization. Duration: 45minutes of session. Frequency: Thrice a Week, Total of 18 sessions in six weeks. 
Intervention  Modified Manual Therapy Approach  MFR of quadtratus lumborum and iliopsoas, MET of lumbar spine and sacrum. Duration: 45minutes of session. Frequency: Thrice a Week, Total of 18 sessions in six weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients having low back pain with or without leg pain.Patients with diagnosed case of stenosis from having MRI findings suggesting lumbar canal stenosis with antero-posterior canal diameter range less than or equal to 12mm. 
 
ExclusionCriteria 
Details  Patients with history of any prior spinal surgery or recent trauma. any present conditions such as pregnancy, carcinoma, diabetes mellitus, Tb spine, renal failure or tumor. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale, Oswestry Disability Questionnaire, Neural Claudication Questionnaire, Straight Leg Raise.  Start of the intervention and end of the intervention, i.e., at the end of 18th session in 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   N/A 
Date of First Enrollment (India)   26/12/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [madhulikasethiya@gmail.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 30-06-2031?
    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 - NIL
Brief Summary   This will be randomized, parallel-group, active-control clinical trial aimed at evaluating the effect of Modified Manual Therapy Approach, Integrated Osteopathic Approach and Conventional Physiotherapy in Lumbar Canal Stenosis.

Participants will be recruited from the accessible population after pre-screening and assessment based on the inclusion and exclusion criteria. Each participant will be informed about the study procedure in a language understandable to them, and a written consent will be obtained before enrollment.

Eligible participants will be randomly allocated into three groups using simple random sampling through online Study Randomizer tool.
The allocation will be on the basis of code provided to the participants with the randomized sequence maintained. 

The study will have three treatment methods conducted in parallel:
1) Group A - Experimental group: Modified Manual Therapy Approach - will recieve MFR of quadratus lumborum and iliopsoas, MET of lumbar and sacrum.
2) Group B- Experimental group: Integrated Osteopathic Approach - will recieve lumbo-sacral release, dural mobilization, sacral release and sacral rhythm.
3) Group C- Control group: Conventional Physiotherapy- will recieve Moist Heating for low back area (using Hydrocollateral Pack), Electrotherapy modality TENS, exercises for lower back.

The three groups will undergo 6 weeks of treatment programme with 18 session in it ( alternate session in a week; 3 sessions in one week)

The pre and post intervention assessments will be carried out using outcome measures mentioned above to see the most benefited group.
 
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