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CTRI Number  CTRI/2024/03/064385 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
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   Effect of spinal exercises on balance in football players with long term back pain. 
Scientific Title of Study   The Effect Of Spinal Stabilization Exercises On Dynamic Balance In Football Players With Chronic Low Back Pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chirag Rewariya 
Designation  PG Scholar 
Affiliation  Amity Institute Of Health Allied Sciences, Amity University, NOIDA 
Address  Room no.11, Lower Ground Floor , F1 Block ,Department of Physiotherapy ,Amity Institute of Health Allied Sciences,Amity Rd, Sector 125, Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9717088038  
Fax    
Email  chiragrewariya26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anu Bansal 
Designation  Assistant Professor III 
Affiliation  Amity Institute Of Health Allied Sciences, Amity University, NOIDA 
Address  Room no.107 A, First Floor , F1 Block ,Department of Physiotherapy ,Amity Institute of Health Allied Sciences, Amity Rd, Sector 125, Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9999620738  
Fax    
Email  abansal@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Anu Bansal 
Designation  Assistant Professor III 
Affiliation  Amity Institute Of Health Allied Sciences, Amity University, NOIDA 
Address  Room no.107 A, First Floor , F1 Block ,Department of Physiotherapy ,Amity Institute of Health Allied Sciences, Amity Rd, Sector 125, Noida, Uttar Pradesh


UTTAR PRADESH
201301
India 
Phone  9999620738  
Fax    
Email  abansal@amity.edu  
 
Source of Monetary or Material Support  
Amity Institute Of Health Allied Sciences Amity University NOIDA Uttar PRADESH 
 
Primary Sponsor  
Name  Chirag Rewariya 
Address  Room no.11, Lower Ground Floor , F1 Block ,Department of Physiotherapy ,Amity Institute of Health Allied Sciences, Amity Rd, Sector 125, Noida, Uttar Pradesh  
Type of Sponsor  Other [(self)] 
 
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 
Chirag Rewariya  Motionflex Physio Clinic  F-18, ground floor, shop no-4, block-F, Jaitpur Extension part 2, Badarpur near Balaji Chowk Delhi-44
South
DELHI 		 9717088038

chiragrewariya26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional NTCC Committee Amity Institute of Health Allied Sciences AMITY UNIVERSITY UTTAR PRADESH  Approved 
Motionflex Physio Clinic  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  The Control group protocol will consist of exercises which will be done for 4 times a week for 4 weeks. The Control Group performed a GE program, consisting of ROM and flexibility exercises for the low back and lower extremities. Each participant was instructed to perform four exercises in total, one exercise from each of the following four categories: (a) knee to chest, (b) lower trunk rotation, (c) prone press-ups, and (d) hamstring stretch exercises. Knee to chest exercises consists of a.) Single knee to chest exercise with pain free(10 repetitions per leg with 10 seconds hold) ,b.) Single knee to chest exercise to end range(10 repetitions per leg with 10 seconds hold) , c.)Double knees to chest exercise(20 repetitions with 10 seconds hold). Lower trunk rotation exercises consists of a.)Lower trunk rotation with pain free range(10 repetitions for each side with 10 seconds hold), b.)Lower trunk rotation to end range(10 repetitions for each side with 10 seconds hold), c.)Lower trunk rotation with legs lifts(10 repetitions for each side with 10 seconds hold ). Hamstring stretch exercises consists of a.) Hamstring stretch with pain free range(10 repetitions per leg with 10 seconds hold), b.) Hamstring stretch with pain free to end range(10 repetitions per leg with 10 seconds hold), c.)Seated Hamstring Stretch(10 repetitions per leg with 10 seconds hold ). Prone press-ups exercise consists of a.) Prone on elbow(20 repetitions with 10 seconds hold), b.) Prone press-ups with pain free(20 repetitions with 10 seconds hold), c.)Prone press-ups to end range(20 repetitions with 10 seconds hold). These exercises were progressed by increasing repetitions and pain-free ROM. 
Intervention  Experimental Group  The Intervention protocol will consists of exercises which will be done for 4 times a week for 4 weeks. Each participant was instructed to perform four exercises in total, one exercise from each of the following four categories: (a) abdominal bracing, (b) quadruped, (c) prone plank, and (d) side plank exercises. Abdominal bracing exercises consists of a.) bracing with heel slides (15 repetitions per leg with 4 seconds hold) , b.)bracing with leg lifts (15 repetitions per leg with 4 seconds hold) and c.)bracing with bridging(30 repetitions per leg with 8 seconds hold). Quadruped Exercises consists of a.) quadruped arm lifts with bracing(15 repetitions per arm with 8 seconds hold), b.)Quadruped leg lifts with bracing(15 repetitions per arm with 8 seconds hold), c.)Quadruped alternate arm and leg lifts with bracing(15 repetitions per arm with 8 seconds hold). Prone plank exercises consists of a.) knee plank(30 repetitions with 8 seconds hold) , b.) prone plank(30 repetitions with 8 seconds hold), c.)prone plank with leg lifts(15 repetitions per leg with 8 seconds hold). Side plank Exercises consists of a.)side plank with knees flexed(15 repetitions for each side with 8 seconds hold), b.)side Plank with knees extended(15 repetitions for each side with 8 seconds hold), c.)Side plank with leg lifts(15 repetitions for each side with 8 seconds hold). For the SSEs, the progression of exercises was based on the participants’ performance at each supervised PT session. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  (i) Chronic low Back pain
(ii) Male Amateur Football Players
(iii)Regular practice (three times a week, one and a half hour each)
(iv) willingness to be monitored
(v) a minimum pain intensity score of 2/10 using the nprs. 
 
ExclusionCriteria 
Details  (i) spinal conditions
(ii)nerve root compression
(iii)history of lower extremity or lumbar spinal surgery
(iv)history of knee and ankle pain since last year
(v)systemic diseases
(vi)vestibular or other balance disoders
(vii)concussion within the previous three months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
(i) Dynamic Balance
(ii) Chronic Low Back Pain
(iii) Core stability and Endurance 		 meausred at baseline and after 4 weeks of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/03/2024 
Date of Study Completion (India) 13/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Chronic low back pain (CLBP) is a prevalent issue affecting a significant proportion of athletes, including football players, worldwide. This debilitating condition not only impairs an athlete’s physical performance but also poses long-term challenges to their career and overall quality of life. Amidst the various therapeutic approaches available, spinal stabilization exercises have emerged as a promising intervention to address CLBP in athletes. In the context of football, a sport demanding precise control of dynamic balance, investigating the impact of spinal stabilization exercises on athletes with CLBP becomes paramount. 
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