| CTRI Number |
CTRI/2025/07/090301 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| 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
|
A Study to Compare the Short Term Effect of Active Release Technique vs Positional Release Technique on Active Upper Trapezius Trigger Points in Individuals with Non-Specific Neck Pain- A Randomized Controlled trial. |
|
Scientific Title of Study
|
A Study to Compare the Short Term Effect of Active Release Technique vs Positional Release Technique on Active Upper Trapezius Trigger Points in Individuals with Non-Specific Neck Pain- A Randomized Controlled 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 Riya Wase |
| Designation |
Physiotherapist |
| Affiliation |
D Y Patil University, School of Physiotherapy, Nerul, Navi Mumbai |
| Address |
Dy Patil University School Of Medicine, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Mumbai, Navi Mumbai, Maharashtra 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9552002586 |
| Fax |
|
| Email |
waseriya31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shellette D Almeida |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil University, School of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D.Y Patil University School of Physiotherapy, Sri Chandrasekarendra saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar , Sector 5, Nerul, Navi Mumbai maharashtra, 400706
Thane MAHARASHTRA 400706 India |
| Phone |
8073899826 |
| Fax |
|
| Email |
shellette.almeida@dypatil.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Riya Wase |
| Designation |
Physiotherapist |
| Affiliation |
D Y Patil University, School of Physiotherapy, Nerul, Navi Mumbai |
| Address |
D Y Patil University School Of Medicine, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Mumbai, Navi Mumbai, Maharashtra
Thane MAHARASHTRA 400706 India |
| Phone |
9552002586 |
| Fax |
|
| Email |
waseriya31@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Riya Wase |
| Address |
Dy Patil University School Of Medicine, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Mumbai, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shellette D Almeida |
D.Y Patil University, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagr, Sector 5, Nerul, Navi Mumbai, Maharashtra, 400706 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Riya Wase |
D Y Patil University |
Dy Patil University School Of Medicine, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Mumbai, Navi Mumbai, Maharashtra Thane MAHARASHTRA |
9552002586
waseriya31@gmail.com |
| Dr Shellette D Almeida |
D Y Patil University |
D.Y Patil University, Sri Chandrasekarendra Saraswati Vidyapuram, Plot 1-E, Dr D Y Patil Vidyanagr, Sector 5, Nerul, Navi Mumbai, Maharashtra, 400706 Thane MAHARASHTRA |
8073899826
shellette.almeida@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D Y Patil Institutional Ethics Committe For Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Trapezitis
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Active Release Technique |
Group A: Active Release Technique will be given to the patients for 8 reps of 1 set. The patient will be asked to sit on a chair and actively flex their neck and rotate first to left side while the therapist applies pressure on the trigger point. The patient will be assessed at baseline and again after 48hr |
| Comparator Agent |
Group B: Positional release Technique |
Group B: Positional release Technique will be given to the patient for 3-5 reps of 1 set. the patient will be taken in supine position, the therapist will palpate the trigger point and then bring the patients shoulder in 0 degrees of abduction till the pain is reduced. Then the therapist will flex the neck on the side palpated by the therapist. the therapist then will instruct the patient to isometrically contract their shoulder while the therapist resists the movement. The patient will be assessed at baseline and again after 48hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Individuals with non specific neck pain more than 3 months.
Individuals with age group above 18 years till 40 years.
Both males and females
Patients who have trigger points in upper trapezius muscle.
Neck pain with mobility deficit
• Unilateral neck pain
• Neck motion limitations
• Onset of symptoms is often linked to a recent unguarded/awkward movement or position
• Associated (referred) upper extremity pain may be present.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Individuals with any history of trauma, fracture or surgery in the neck or upper back or shoulder.
Individuals with any skin diseases in the trapezius area.
Individuals with neck and back deformities.
Individuals with radiculopathy.
Neck pain with headache, neck pain with movement coordination impairments, neck pain with radiating pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Pressure Threshold
Cervical Range of Motion |
they will be assessed pre and post intervention immediately and after 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Neck Disability Index |
They will be assessed pre and post intervention immediately and after 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
15/07/2025 |
| 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="1" Months="0" 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
|
Non-specific neck pain is a common musculoskeletal disorder where about 80% of adult population suffers from neck pain during their lifetime. It is a symptom related to postural or mechanical causes and is associated with disability and reduced quality of life. Neck pain is present with weakness and muscular imbalance and has a close relationship between muscle prone to tightness and those prone to inhibition. In case of neck pain, tightness of upper trapezius is present which leads to weakness of other muscles. Both the techniques ART and PRT use similar principles aimed at localizing and treating specific areas of restriction within the fascial system and are intended to release scar tissue, treat facial adhesions, or to reduce tightness within the musculotendinous unit. |