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CTRI Number  CTRI/2025/12/100002 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 17/12/2025
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   Effect of Audio-Visual Biofeedback Training on Back Muscle Strength and Daily Activities in College Students with Low Back Pain. 
Scientific Title of Study   To evaluate the effectiveness of an audio-visual biofeedback device on back extensor muscle strength and functional performance in college-going students with non-specific 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  Vruti Dhameliya 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK University  
Address  Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturba Dham, Rajkot-Bhavnagar Highway, Rajkot Rajkot Gujarat 360020 India

Rajkot
GUJARAT
360020
India 
Phone  9712524899  
Fax    
Email  vdhameliya446@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Komal Doshi 
Designation  Assistant Professor, School of Physiotherapy, RK University  
Affiliation  School of Physiotherapy, RK University  
Address  Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturba Dham, Rajkot-Bhavnagar Highway, Rajkot Rajkot Gujarat 360020 India

Rajkot
GUJARAT
360020
India 
Phone  7405346112  
Fax    
Email  komal.doshi@rku.ac.in   
 
Details of Contact Person
Public Query  
Name  Vruti Dhameliya 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK University  
Address  Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturba Dham, Rajkot-Bhavnagar Highway, Rajkot Rajkot Gujarat 360020 India

Rajkot
GUJARAT
360020
India 
Phone  9712524899  
Fax    
Email  vdhameliya446@rku.ac.in  
 
Source of Monetary or Material Support  
School of Physiotherapy, RK University 
 
Primary Sponsor  
Name  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot Rajkot Gujarat 360020 India  
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 
Vruti Dhameliya  School of Physiotherapy, RK University  Research Department, Room no. 207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot Rajkot Gujarat 360020 India
Rajkot
GUJARAT 		 9712524899

vdhameliya446@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, School of Physiotherapy, RK University.  Approved 
 
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 
Intervention  Audio-visual Biofeedback Device  The interventional group will be asked to bridge normally on command & assess the back extensor muscle strength, height of bridge hold & duration of hold. A core & lumbar strengthening exercise protocol will be given.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Have non specific low back pain (no clear cause).
2. Mild to moderate pain (pain score 2 to 7 on the NPRS scale).
3. Can perform basic movements like bridging, sitting, and standing.

 
 
ExclusionCriteria 
Details  1. Severe back pain (pain score of 8 or more).
2. Neurological disorders related to the spine.
3. Serious bone or joint disorders (like fractures or arthritis).
4. Major mental health problems (like severe anxiety or depression).
5. Had surgery of the spine before.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Audio-visual Biofeedback Device  1st day and end of 4th week
 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Performance ( using Oswestry Disability Index ).
 		 1st day and end of 4th week 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/01/2026 
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="6"
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 - NO
Brief Summary  

This study aims to evaluate the effectiveness of an audio-visual biofeedback device in improving back extensor muscle strength and functional performance among college-going students with non-specific low back pain (NSLBP). The device provides real-time visual and audio feedback during bridging and core-strengthening exercises, helping participants enhance movement control, posture, and muscular activation. Its effectiveness will be determined by comparing pre- and post-intervention outcomes following a structured 4-week training program.Outcome measures include back extensor muscle strength (measured using the biofeedback device), pain intensity (NPRS), and functional performance (Oswestry Disability Index). The null hypothesis states that there is no significant improvement in muscle strength or functional performance after using the audio-visual biofeedback device, while the alternate hypothesis states that the device leads to significant improvement. The study will include 150 participants, conducted over 6 months in a physiotherapy department and rehabilitation center.

 
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