| CTRI Number |
CTRI/2026/03/105466 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| 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
|
Study Comparing Two Physiotherapy Methods for Relief of Neck Pain and Muscle Spasm in Students |
|
Scientific Title of Study
|
Effectiveness of Integrated neuromuscular inhibition technique
with Ruddys Reciprocal Antagonist Facilitation and Positional
Release Technique in undergraduate students with trigger points in
Trapezius: A 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 Aditi Dattatraya Lokhande |
| Designation |
Post Graduate Student |
| Affiliation |
Rashtrasant Jananrdhan College of Physiotherapy |
| Address |
Rashtrasant Jananrdhan Swami College Of Physitherapy 1st floor MPT classroom no.2 Kokamthan Tal Kopargaon Dist Ahmadnagar 423601 Maharshtra Ur Sciences Nashik
Ahmadnagar MAHARASHTRA 423601 India |
| Phone |
7058950949 |
| Fax |
|
| Email |
laditi0207@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manikandan P |
| Designation |
Professor and HOD |
| Affiliation |
Rashtrasant Janardhan Swami College Of Physiotherapy Kopargaon |
| Address |
Rashtrasant Jananrdhan Swami College Of Physitherapy 2nd floor MSK Department HOD cabin Kokamthan Tal Kopargaon,Dist-Ahmadnagar 423601 Maharshtra Ur Sciences Nashik
Ahmadnagar MAHARASHTRA 423601 India |
| Phone |
6374653504 |
| Fax |
|
| Email |
mani2bpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aditi Dattatraya Lokhande |
| Designation |
Post Graduate Student |
| Affiliation |
Rashtrasant Janardhan Swami College Of Physiotherapy Kopargaon |
| Address |
Rashtrasant Jananrdhan Swami College Of Physitherapy 1st floor MPT Classroom no.2 Kokamthan Tal Kopargaon Dist Ahmadnagar 423601 Maharshtra Ur Sciences Nashik
Ahmadnagar MAHARASHTRA 423601 India |
| Phone |
7058950949 |
| Fax |
|
| Email |
laditi0207@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rashtrasant Jananrdhan Swami College Of Physitherapy,Kokamthan ,Tal Kopargaon,Dist-Ahmadnagar,423601 Maharshtra Ur Sciences ,Nashik
|
|
|
Primary Sponsor
|
| Name |
Dr Aditi Dattatraya Lokhande |
| Address |
Rashtrasant Jananrdhan Swami College Of Physitherapy,Kokamthan ,Tal Kopargaon,Dist-Ahmadnagar,423601 Maharshtra Ur Sciences ,Nashik
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aditi Dattatraya Lokhande |
RJS group of Medical Institutes |
Rashtrasant Janardhan Swami Hospital Basement1 Physiotherapy OPD Musculoskeletal Department Kopargaon Ahmadnagar 423601 Maharashtra University Of Health Sciences Nashik Ahmadnagar MAHARASHTRA |
7058950949
laditi0207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RJS College of Physiotherapy[MUHS] Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
upper trapezitis
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Neuromuscular Inhibition Technique (INIT) with Ruddys reciprocal antagonist facilitation |
Identification of Trigger Point
The most tender point in the upper trapezius will be identified by palpation.
Ischemic Compression
Sustained digital pressure will be applied over the trigger point for approximately 30–60 seconds or until pain reduces.
Strain-Counterstrain (Position of Ease)
The muscle will be positioned in a shortened, comfortable position and held for 90 seconds, followed by slow return to neutral.
Muscle Energy Technique (Post-Isometric Relaxation)
The patient will perform a gentle isometric contraction (20–30% effort) of the upper trapezius for 7–10 seconds against therapist resistance, followed by relaxation and passive stretch.
RRAF Component
The antagonist muscles (lower trapezius and deep neck flexors) will be facilitated using gentle resisted contractions to promote reciprocal inhibition and improve neuromuscular balance.
Intervention will be given for 2 weeks 5days a week |
| Comparator Agent |
positional release technique |
Tender/trigger point will be identified in the upper trapezius.
The muscle will be positioned in a shortened position that reduces tenderness by at least 70%.
This position will be maintained for approximately 90 seconds.
The muscle will then be slowly and passively returned to neutral position.
A gentle stretch may be applied following release.
The intervention will be given for 2 weeks 5 days a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
• Undergraduate students
• Upper trapezius spasm since 7days to 7 weeks
• Tenderness grade 2 and 3 over upper trapezius fibers
• Willing to participate
|
|
| ExclusionCriteria |
| Details |
• Recent history of trauma or fracture in cervical spine
• Tenderness grade 4 over the upper trapezius
• Recent cervical spine surgery
• Skin disease around part to be treated
• Signs of Cervical radiculopathy or myopathy
• Neck deformities like scoliosis or torticollis
• Sensory disturbance near treating part
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale[0 to 10] for measuring pain outcome
|
at baseline and 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cervical range of motion
|
at baseline and 2 weeks of intervention |
| Neck Disability Index Scale |
at baseline and 2 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
20/03/2026 |
| 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)
|
Open to Recruitment |
| 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
|
Musculoskeletal neck pain due to upper trapezius spasm is highly prevalent among graduating students, primarily due to prolonged sitting, poor posture, and excessive use of electronic devices. Persistent muscle spasm and latent trigger points may result in pain, restricted cervical range of motion, and functional disability. This randomized comparative study aims to evaluate the effectiveness of Integrated Neuromuscular Inhibition Technique (INIT) combined with Ruddy’s Reciprocal Antagonist Facilitation (RRAF) versus Positional Release Technique (PRT) in reducing pain and improving functional outcomes in students with upper trapezius spasm. Participants fulfilling the inclusion criteria will be randomly allocated into two groups. Group A will receive INIT combined with RRAF, and Group B will receive PRT. Interventions will be administered over a specified treatment duration. Outcome measures including pain intensity, cervical range of motion, and neck-related functional disability will be assessed at baseline and post-intervention using standardized assessment tools. The study aims to determine the comparative effectiveness of these manual therapy techniques in improving pain, muscle function, and quality of life among graduating students. |