CTRI

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CTRI Number

CTRI/2025/03/082677 [Registered on: 18/03/2025] Trial Registered Prospectively

Last Modified On:

17/03/2025

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

Effectiveness of Positional Release Technique in Reducing Muscle Tenderness, Improving Shoulder Posture, and Enhancing Quality of Life in People with Rhomboid Muscle Pain.

Scientific Title of Study

Efficacy of Positional Release Technique on Tenderness, Level of Scapular Protraction and Quality of Life in Patients with Rhomboid Myofascial Pain Syndrome

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Shubham Jain
Designation	Student
Affiliation	SGT University
Address	Department of Faculty of Physiotherapy, SGT University Gurgaon HARYANA 122505 India
Phone	7042437035
Fax
Email	shubham1504jain@gmail.com

Details of Contact Person
Scientific Query

Name	Siddhartha Sen
Designation	Professor and Associate Dean
Affiliation	SGT University
Address	Department of Faculty of Physiotherapy Gurgaon HARYANA 122505 India
Phone	9412985124
Fax
Email	siddhartha_fphy@sgtuniversity.org

Details of Contact Person
Public Query

Name	Anushree Rai
Designation	Assistant Professor
Affiliation	SGT University
Address	Department of Faculty of Physiotherapy Gurgaon HARYANA 122505 India
Phone	8937881164
Fax
Email	anushree.rai@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Shubham Jain
Address	Faculty of Physiotherapy, SGT University, Chandu Budhera Village 122505
Type of Sponsor	Other [Self]

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
Shubham Jain	SGT Medical College taland Hospi	Department of Physiotherapy, Basement Floor Gurgaon HARYANA	7042437035 shubham1504jain@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Departmental Ethical Committee, Faculty of Physiotherapy, SGT University	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M959\|\|Acquired deformity of musculoskeletal system, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Group - 2 : Control Group	The participants will be given Hot pack and TENS modality. The Hot Pack will be given for 10 minutes and the TENS electrode will be placed over the rhomboid muscle for 10 minutes. The treatment will be given thrice a week for 3 weeks.
Intervention	Group 1 - Positional Release Technique along with conventional treatment	Patient will receive Positional release technique over their rhomboid muscles along with hot pack and TENS modality. The PRT will be given 3 repetition and the hot pack will be given for 10 minutes and TENS electrode will be placed over the rhomboid muscle for 10 minutes. The treatment will be given thrice a week for 4 weeks.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	35.00 Year(s)
Gender	Both
Details	The participants should have been diagnosed with Rhomboid Myofascial Pain Syndrome with the following characteristics: a. Taut band palpable. b. Regional pain complaint. c. Tender nodule palpated with taut band of muscle fiber.

ExclusionCriteria

Details

1. Participants having signs of fibromyalgia will excluded to diffuse the tenderness level.
2. Participants taking analgesics need to wash out 48 hours prior.
3. Participants should not receiving any other form of treatment for their condition.
4. Participants of diagnosed medical conditions of the shoulder and neck will be excluded.
5. Participants suffering from diabetes, hypertension will be excluded.

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

Participant Blinded

Primary Outcome

Outcome	TimePoints
Tenderness, Scapular Protraction Range, Scapular Retraction Range, Quality of Life	the outcome measure will be assessed at the baseline and post intervention after 4th week.

Secondary Outcome

Outcome	TimePoints
Pectoralis Major Muscle Length, Pectoralis Minor Muscle Length, Proprioception	The Outcome measure will be assessed at the baseline & post intervention after 4 weeks

Target Sample Size

Total Sample Size="58"
Sample Size from India="58"
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)

28/03/2025

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="0"
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

Musculoskeletal disorders (MSDs) are a major cause of chronic pain and functional disability, affecting millions of individuals worldwide. These conditions involve the muscles, bones, tendons, and ligaments, leading to discomfort, restricted mobility, and impaired quality of life. Among MSDs, Myofascial Pain Syndrome (MPS) is a prevalent condition characterized by localized muscle pain, stiffness, and the presence of trigger points—hyperirritable spots within a muscle that can cause referred pain. MPS commonly affects various muscle groups, with the rhomboid muscles being particularly susceptible due to their role in scapular stabilization and posture maintenance.

Rhomboid Myofascial Pain Syndrome (RMPS) is a specific form of MPS that occurs due to overuse, poor posture, muscle imbalances, or repetitive strain. Individuals suffering from RMPS often experience persistent upper back pain, tenderness, muscle tightness, and postural abnormalities, such as increased scapular protraction. These symptoms can significantly impact daily activities, work performance, and overall well-being. Traditional treatment modalities for RMPS include stretching, strengthening exercises, trigger point therapy, and postural correction. However, these interventions may not always provide long-lasting relief, necessitating the exploration of alternative therapeutic approaches.

Positional Release Technique (PRT) is a gentle, non-invasive manual therapy technique designed to alleviate musculoskeletal pain by placing affected muscles in a position of ease, allowing them to relax and reducing trigger point activity. This method has gained attention as an effective approach for reducing muscle tenderness, improving mobility, and enhancing neuromuscular function. PRT has been successfully utilized in managing various musculoskeletal conditions, but its efficacy in treating RMPS remains under-researched.

This study aims to evaluate the effectiveness of Positional Release Technique in reducing tenderness, correcting scapular protraction, and improving quality of life in patients with Rhomboid Myofascial Pain Syndrome. By investigating PRT as a therapeutic intervention, this research seeks to bridge the existing knowledge gap and provide evidence-based insights into its clinical applicability. The findings of this study may contribute to enhancing physiotherapy practices and developing improved treatment protocols for patients suffering from RMPS.

NULL HYPOTHESIS

H₀¹ : There is no significant difference in reduction of tenderness in rhomboid muscles between patients with rhomboid myofascial pain syndrome who receive positional release technique (PRT) intervention and those who do not.

H₀² : There is no significant improvement in scapular protraction range among patients diagnosed with rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₀³ : There is no significant improvement in scapular retraction range among patients diagnosed with rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₀⁴ : There is no significant improvement in the quality of life of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₀⁵ : There is no significant improvement in the proprioception of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₀⁶ : There is no significant improvement in the pectoralis major muscle length of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₀⁷ : There is no significant improvement in the pectoralis minor muscle length of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

ALTERNATE HYPOTHESIS

H₁¹: There is a significant difference in the reduction of tenderness in rhomboid muscles between patients with rhomboid myofascial pain syndrome who receive positional release technique (PRT) intervention and those who do not.

H₁²: There is significant improvement in scapular protraction range among patients diagnosed with rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₁³: There is significant improvement in scapular retraction range among patients diagnosed with rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₁⁴: There is significant improvement in the quality of life of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₁⁵: There is significant improvement in the proprioception of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₁⁶: There is significant improvement in the pectoralis major muscle length of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.

H₁⁷: There is significant improvement in the pectoralis minor muscle length of individuals suffering from rhomboid myofascial pain syndrome who undergo positional release technique (PRT) intervention.