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CTRI Number  CTRI/2021/09/036675 [Registered on: 21/09/2021] Trial Registered Prospectively
Last Modified On: 04/10/2023
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   Studies on understanding the role of physiotherapy interventions on chronic low back pain in university athletic population. 
Scientific Title of Study   Studies on Understanding the Role of Physiotherapeutic Interventions in University Athletes with Chronic Low Back Pain. 
Trial Acronym  CLBP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saurabh Sharma 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia University 
Address  Room no.-104, First Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University, New Delhi, India

New Delhi
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Saurabh Sharma 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia University 
Address  Room no.-104, First Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University, New Delhi, India

New Delhi
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  Sumbul Ansari 
Designation  Ph.D. Scholar 
Affiliation  Jamia Millia Islamia University 
Address  Room no.-102, First Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University, New Delhi, India

New Delhi
DELHI
110025
India 
Phone  8285234492  
Fax    
Email  sumbulansari3@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia University, New Delhi, India 110025 
 
Primary Sponsor  
Name  Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia University 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University, Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, New Delhi 110025 
Type of Sponsor  Other [Central University] 
 
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 
Saurabh Sharma  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University, Maulana Mohammed Ali Jauhar Marg, Jamia Nagar, New Delhi, India 110025
New Delhi
DELHI 		 9899214134

ssharma@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jamia Millia Islamia University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M998||Other biomechanical lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise (Extensor exercise plus motor control/stabilization exercise )  motor control/stabilization exercise divided into four phases (progression added to each phase) plus extensor training divided into four phases (progression added to each phase). The program will consist of 5 minutes of warm up and cool down. The duration of the exercise program will be 8 weeks. 
Comparator Agent  Exercise (Extensor exercise)  Extensor exercise divided into four phases (progression added to each phase). The program will consist of 5 minutes of warm up and cool down. he duration of the exercise program will be 8 weeks. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  Prevalence Study:

University level athletes who have a sporting experience at the university level of at least 1 year.

Age: 18-30 years

Gender: Male/ Female

Able to comprehend instructions in English.


Interventional Study:

University level athletes

LBP for ≥3 months

Age: 18-30 years

Gender: Male

Athlete Disability Index (ADI) score: mild to moderate

NPRS score: 2-6

Sorensen’s test hold time <60 seconds.

Able to comprehend instructions in English.

Subject agrees to participate in the study protocol. 
 
ExclusionCriteria 
Details  Interventional Study:

Body mass index >35kg/m2, as this affects the electrical conductivity of the multifidus muscle due to fatty infiltration.

Other orthopaedic or medical condition present, apart from low back pain.

Signs and symptoms of inflammatory disorder(s).

Subjects currently on medication like NSAIDs or received steroid injection in past 12 months.

Subjects with prior spine surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Balance/Postural control
Muscle activity and performance 		 baseline, 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Pain
Disability
Global perceived outcome
Physical performance
Health related quality of life
Sleep 		 baseline, 8th week 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
This study will help to provide the rate of prevalence of chronic low back pain (CLBP) in Indian university level athletes across different sports and also help to find  several associated factors in this population which will further help to design a clinically useful intervention for this population. The sample size for the prevalence (cross-sectional observational study) is n=323, the athletes diagnosed with CLBP and fulfilling the eligibility criteria will be subject to the assessment of muscle fatigability, an additional number of healthy athletes will be randomly selected for the same, whereas the sample size for that of the interventional part is n=48.

The present study will elucidate the effect motor control stabilization exercises and extensor training in the treatment of varsity athletes suffering from chronic low back pain. If came out with positive findings, the present study protocol may be used for the treatment of athletes suffering from chronic low back pain, which is a major reason for pain related shift in the athlete’s focus from competition to rehabilitation.
 
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