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CTRI Number  CTRI/2025/10/096407 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
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   Impact OF virtual reality Relaxation Exercise Versus Relaxation Exercises In Desk Job Workers With Non-Specific Low Back Pain 
Scientific Title of Study   Impact OF Guided Imagery Relaxation Exercise Versus Relaxation Exercises In Desk Job Workers With Non-Specific Low Back Pain: Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhaval Chivate 
Designation  Associate Professor  
Affiliation  KLE Institude of Physiotherapy 
Address  Advanced Physiotherapy center,department of pediatric physiotherapy, room no 39, sagar floor, Belgaum KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  8494869771  
Fax    
Email  dhavalchivate@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Jenessa Pereira 
Designation  BPT intern  
Affiliation  KLE Institude of Physiotherapy 
Address  Advanced Physiotherapy center,department of sports physiotherapy, room no 39, sagar floor, Belgaum KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  9689233507  
Fax    
Email  pereirajenessa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Juveria Desai 
Designation  Undergraduate student( Intern) 
Affiliation  KLE Institude of Physiotherapy 
Address  Advanced Physiotherapy center,department of pediatric physiotherapy, room no 39, sagar floor, Belgaum KARNATAKA

Belgaum
KARNATAKA
590010
India 
Phone  9689233507  
Fax    
Email  juveriadesai@gmail.com   
 
Source of Monetary or Material Support  
KLE Dr Prabhakar Kore hospital and research centre, Nehru Nagar, Belgaum, Karnataka, India, 590010 
 
Primary Sponsor  
Name  KAHER Institute of Physiotherapy 
Address  KLE Dr Prabhakar Kore hospital and research centre, Nehru Nagar, Belgaum, Karnataka, India, 590010 
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 Dhaval Chivate  KAHER Institute of Physiotherapy  Advanced Physiotherapy centre OPD NO.39 department of pediatric physiotherapy room no.21 sagar floor Belgaum KARNATAKA
Belgaum
KARNATAKA 		 8494869771

dhavalchivate@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER institute of physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  hospital desktop workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  JACOBSON PROGRESSIVE MUSCLE RELAXATION EXERCISE   The 3-week Jacobson Progressive Muscle Relaxation program was performed three times per week for individuals with nonspecific low back pain. It involved tensing and relaxing different muscle groups from head to toe to reduce muscle tension and promote relaxation. In week 2, the hold and relaxation times were increased, and in week 3, deep breathing was added to enhance relaxation and pain relief. 
Comparator Agent  VR based guided imagery  The 3-week VR-guided imagery program aimed to reduce pain and improve movement confidence in individuals with chronic low back pain. Week 1 focused on relaxation and pain relief using calming VR scenes, deep breathing, and guided imagery. Week 2 emphasized motor imagery and confidence through visualization of pain-free movements and daily tasks. Week 3 promoted functional integration and self-efficacy by imagining safe physical activities and an active, pain-free lifestyle. 
Intervention  VR based guided imagery exercise versus relaxation exercises   VR-based guided imagery immerses patients in a virtual environment with guided relaxation, enhancing focus and distraction from pain, making it effective for chronic pain and stress but requiring equipment. Traditional relaxation exercises like deep breathing or progressive muscle relaxation are simple, cost-effective, and promote long-term stress relief, though less immersive. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All genders between 25–60 years of age

Participants willing to participate in the study

Desk job workers in healthcare aged 25–60 years

Minimum 4–5 years of work experience

Workers with 20%–40% functional disability according to the Modified Oswestry Disability Index (MODI) 
 
ExclusionCriteria 
Details  Workers with disc prolapse, spinal stenosis, spondylolisthesis, fracture, infection, tumours, lumbar spine surgery within the last 6 months
- Inability to use guided imagery due to vision/hearing impairment uncorrected by aids
-Workers who regularly workout in the gym
- Patients unwilling to participate
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified Oswestry Disability Index  The Modified Oswestry Disability Index (MODI) was assessed at two key timepoints: baseline (pre-intervention) to record initial functional disability, and post-intervention after 3 weeks to evaluate improvement in functional ability. 
 
Secondary Outcome  
Outcome  TimePoints 
visual analogue scale  The Visual Analogue Scale (VAS) was measured at baseline (pre-intervention) to record initial pain levels and post-intervention after 3 weeks to evaluate changes in pain intensity 
PERCIEVED STRESS SCALE (PSS-10)  The Perceived Stress Scale (PSS-10) was assessed at baseline (pre-intervention) to record initial stress levels and post-intervention after 3 weeks to evaluate changes in perceived stress. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 2 
Date of First Enrollment (India)   04/11/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Chronic low back pain (LBP), defined as pain persisting for more than 12 weeks, is a major cause of functional impairment, reduced work productivity, and long-term disability. It typically involves muscle tightness or stiffness in the lumbar region, sometimes radiating to the legs, and is influenced by multiple factors. Physical risk factors include age, body mass, height, and BMI, while psychological factors such as depression, anxiety, and mental fatigue also play a significant role. Chronic LBP can lead to additional complications, including sleep disturbances, increased stress, and reduced quality of life. Non-pharmacological interventions, particularly relaxation techniques, have gained recognition for their effectiveness in managing chronic pain. Evidence from randomized controlled trials suggests that relaxation practices can significantly reduce pain and improve secondary outcomes, such as stress and functional ability. These techniques appear most beneficial when practiced regularly and consistently. However, variations in pain conditions and intervention types necessitate further research to evaluate the long-term effects, optimal duration, and comparative efficacy of different relaxation methods. Overall, relaxation techniques represent a promising approach for managing chronic LBP and enhancing patient well-being. 
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