| CTRI Number |
CTRI/2025/11/096812 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| 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 positional release and virtual reality on pain and function in neck pain individuals. |
|
Scientific Title of Study
|
Effect Of Positional Release Therapy v/s Virtual Reality Based Intervention On Pain And Functional Outcome In Young Adults With Trapezitis A Randomized Clinical Trial |
| 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 Santosh Metgud |
| Designation |
Professor and Vice Principal |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance Physiotherapy Room no 39 Department Of Orthopaedic Manual Therapy Room no 13 Sagar Floor KLE Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi Karnataka 590010 India Advance Physiotherapy Room no 39 Department Of Orthopaedic Manual Therapy Room no 13 Sagar Floor KLE Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi Karnataka 590010 India Belgaum KARNATAKA 590010 India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Professor and Vice Principal |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance Physiotherapy Room no. 39 Department Of Orthopaedic Manual Therapy Room no 13 Sagar Floor KLE Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi Karnataka 590010 India Advance Physiotherapy Room no 39 Department Of Orthopaedic Manual Therapy Room no 13 Sagar Floor KLE Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi Karnataka 590010 India Belgaum KARNATAKA 590010 India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Arya Jinralkar |
| Designation |
Intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advance Physiotherapy Room no 39 Department Of Orthopaedic Manual Therapy Room no 13 Sagar Floor KLE Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi Karnataka 590010 India Advance Physiotherapy Room no 39 Department Of Orthopaedic Manual Therapy Room no 13 Sagar Floor KLE Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi Karnataka 590010 India Belgaum KARNATAKA 590010 India |
| Phone |
8296440797 |
| Fax |
|
| Email |
aryajinralkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital Nehru Nagar Belagavi Karnataka 590010 India |
|
|
Primary Sponsor
|
| Name |
Self sponsored |
| Address |
KLES Dr prabhakar kore hospital and MRC Advanced physiotherapy centre OPD No 39 Belgavi 590010 karnataka |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arya Jinralkar |
KAHER Institute Of Physiotherapy |
Advanced Physiotherapy room no 39 sagar floor KLE Dr Prabhakar Kore Hospital and MRC Nehru nagar Belagavi karnataka 590010 India Belgaum KARNATAKA |
8296440797
aryajinralkar@gmail.com |
| Dr Santosh Metgud |
KAHER Institute Of Physiotherapy |
Advanced Physiotherapy room no 39 sagar floor KLE Dr Prabhakar Kore Hospital and MRC Nehru nagar Belagavi karnataka 590010 India Belgaum KARNATAKA |
9880088400
santoshmetgud@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
trapezitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
positional release therapy and conventional therapy |
IFT for 15 minutes
stretching for 15 minutes with 30 seconds hold
HMP for 10 minutes |
| Comparator Agent |
virtual reality and conventional therapy |
IFT for 15 minutes
stretching for 15 minutes with 30 seconds hold
HMP for 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Participants willing to participate.
All genders between the age group of 18 to 26 years.
Participants with palpable active myofascial trigger point in trapezius muscle.
Pain intensity of more than 4 and less than 7 on VAS and presence of at least one trigger point in a taut band in upper trapezius.
Individuals with grade 2 and 3 trapezius muscle tenderness based on the tenderness grading scale. |
|
| ExclusionCriteria |
| Details |
Individuals with history of surgery to neck or upper back during one last year.
Diagnosed cases of cervical spine.
Individuals with history of whiplash injury.
Individuals with history of trauma or fractures in the neck or upper back or shoulder region.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Visual Analog Scale (VAS)
2 Range of Motion
3 Neck Disability Index
|
1 First week and second week
2 First week and second week
3 First week and second week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
11/11/2025 |
| 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 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
|
Title: EFFECT OF POSITIONAL RELEASE THERAPY V/S VIRTUAL REALITY BASED INTERVENTION ON PAIN AND FUNCTIONAL OUTCOME IN YOUNG ADULTS WITH TRAPEZITIS: A RANDOMIZED CLINICAL TRIAL.
Trapezitis is a common musculoskeletal condition caused by inflammation of the trapezius muscle, presenting with pain, stiffness, and functional limitations in the neck and upper back. It is increasingly prevalent in young adults due to prolonged computer use, sedentary lifestyle, and poor posture. Conventional treatments often provide only temporary relief. Positional Release Therapy (PRT) and Virtual Reality (VR) therapy are emerging non-invasive approaches with potential benefits in pain modulation and muscle relaxation, but their comparative effectiveness in trapezitis remains unexplored. Objective To compare the effect of PRT and VR in individuals with trapezitis on pain, function and Range of motion in terms of Visual Analogue Scale, Neck Disability Index and Goniometer respectively. Methodology A Randomized Clinical trial will be conducted involving young adults diagnosed with trapezitis. Participants will be randomly allocated into two groups: one receiving PRT and the other undergoing VR-based therapy. Outcomes will be assessed pre- and post-intervention using the Visual Analogue Scale (VAS) for pain, Neck Disability Index (NDI) for functional limitation, and goniometric measurement for cervical range of motion. |