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CTRI Number  CTRI/2024/06/068785 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Specialized Exercises In Back Pain Patients 
Scientific Title of Study   Efficacy Of Augmented Active Control Exercise Programme In Disc Prolapse Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snigdha Tiwari 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  Faculty of Physiotherapy, D Block, SGT University,Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505

Gurgaon
HARYANA
122004
India 
Phone  09893533630  
Fax    
Email  snigsneelaadvi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Siddhartha Sen 
Designation  Professor 
Affiliation  SGT University 
Address  Faculty of Physiotherapy, D Block, SGT University,Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505

Gurgaon
HARYANA
122005
India 
Phone  09893533630  
Fax    
Email  siddhartha_fphy@sgtuniversity.org  
 
Details of Contact Person
Public Query  
Name  Snigdha Tiwari 
Designation  Assistant Professor 
Affiliation  SGT University 
Address  Faculty of Physiotherapy, D Block, SGT University,Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505

Gurgaon
HARYANA
122004
India 
Phone  09893533630  
Fax    
Email  snigsneelaadvi@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  SGT University 
Address  SGT University,Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Snigdha Tiwari  SGT Hospital  Room No. 13, Physiotherapy Department, SGT HOspital.Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA 		 09893533630

snigsneelaadvi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Faculty of Physiotherapy SGT University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M518||Other thoracic, thoracolumbar andlumbosacral intervertebral disc disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Augmented Active Control Exercise Programme  These are the exercises composed of multiple level of exercises under the supervision of Physiotherapist for 35 to 40 minutes once a day and for 6 weeks. 
Comparator Agent  Control Group  They will be doing exercises which they are doing earlier. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  a) Diagnosed by Orthopedician for disc prolapse
b) Low back pain with and without radiculopathy
c) Any lumbar level involvement with disc prolapse with clinical signs and symptoms


 
 
ExclusionCriteria 
Details  a) Tumor, Infection, Tuberculosis
b) Any Traumatic condition to pelvis and lower limb
c) Uncontrolled mood disorder
d) Patients having metallic implants
e) Recurrent disc herniation
f) Use of analgesic drugs in preceding week which will affect the pain
g) Progressive motor neurological deficit- No bladder/bowl symptoms/difficulty in walking
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Proprioception, Range of Motion  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Owestry Disability Index  1 year 
 
Target Sample Size   Total Sample Size="83"
Sample Size from India="83" 
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)   23/06/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 "Exploring the Potential of Augmented Active Control Exercise Program in Managing Disc Prolapse: A Pilot Study". Journal Name: International Journal of Environmental Sciences ISSN: 2229-7359 DOI: https://doi.org/10.64252/d31d7z21 Publication Link: https://theaspd.com/index.php/ijes/article/view/5857  
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 - Informed Consent Form

  3. Who will be able to view these files?
    Response (Others) -  Only the data will be shared under the publication of this work

  4. For what types of analyses will this data be available?
    Response (Others) -  Data will be for shared in the publications and it will be available for performing meta-analysis on authors request

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available for performing meta-analysis on authors request

  6. For how long will this data be available start date provided 16-06-2024 and end date provided 16-09-2025?
    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    Lumbar Disc Herniation  is a common disorder that causes disability and poor quality of life by limiting functional capacity. This study aims to evaluate the effect of Augmented control  exercise programe in disc prolapse patients. 
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