- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07720544
Instrument-assisted Soft Tissue Mobilization Versus Post - Isometric Relaxation Technique in Trapezius Myalgia. (IASTM)
July 17, 2026 updated by: Riphah International University
Effects of Instrument -Assisted Soft Tissue Mobilization Versus Post - Isometric Relaxation Technique on Pain,Range of Motion, and Function in Patients With Trapezius Myalgia.
effects of Instrument Assisted Soft Tissue Mobilization (IASTM) and Post-Isometric Relaxation (PIR) in reducing pain, improving range of motion, and enhancing function among individuals with trapezius myalgia.
it was a randomized clinical trial with outcome measuring tools as NPRS for pain Goniometer for ROM NDI for function
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized clinical trial was carried out over ten months at Arif Memorial Teaching Hospital in Lahore.
The study included 48 participants aged between 25 and 35 years, selected through non-probability convenience sampling; 44 completed the full treatment.
Participants were randomly divided into two groups of 22 each using a lottery method.
Group A underwent IASTM combined with passive and self-stretching exercises, while Group B received the PIR technique.
Both interventions were administered three times weekly for six weeks.
Outcomes were assessed using the Numeric Pain Rating Scale (NPRS) for pain, a universal goniometer to measure cervical lateral flexion and rotation range of motion, and the Neck Disability Index (NDI) to evaluate functional limitations.
Evaluations were performed before treatment and again at the end of the six-week intervention.
Data analysis was conducted using SPSS-25, involving the Shapiro-Wilk test to assess normality, independent t-tests and Mann-Whitney U tests for intergroup comparisons, and paired t-tests along with Wilcoxon Signed Rank tests for intragroup analysis.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Arif memorial teaching hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals aged 25 to 35 experiencing trapezius myalgia,
- both men and women who report neck pain and stiffness,
- Limited range of motion in lateral neck bending and rotational movement.
- Presence of identifiable tender areas or trigger points within the trapezius muscle, Evidence of muscle tightness observed during mobility assessments, such as when performing lateral head tilt.
- A firm band of muscle tissue containing a hypersensitive point, often with a palpable nodule and potential for radiating discomfort.
Exclusion Criteria:
- Traumatic injury to the neck causing torticollis,
- Tumor affecting the upperportion of the trapezius muscle,
- Cervical nerverootirritation or damage, Break in one or more cervical vertebrae,
- Impairment of nervous system function,
- Swelling and hypersensitivity reactions in the skin,
- Abnormal spinal curvature and birth-related structural defects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GROUP 1 (Intrument assisted soft tissue mobilization)
IASTM (Members of this group received instrument-assisted soft tissue mobilization in addition to a standard intervention aimed at reducing pain and enhancing range of motion and functional ability.)
|
IASTM intervention was administered three times weekly for six weeks.
|
|
Active Comparator: GROUP 2(Post isometric relaxation)
Post isometric relaxation(The members of this group underwent post-isometric relaxation combined with the same standard protocol, with the same goals of alleviating pain and improving mobility and function.)
|
PIR intervention was administered three times weekly for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: Baseline and after 6 weeks
|
The pain intensity was assessed using Numeric Pain Rating Scale (NPRS) an 11-point (0-10) tool used to measure a patient's pain intensity, where 0 means "no pain" and 10 means "the worst pain imaginable
|
Baseline and after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: Baseline and after 6 weeks
|
ROM was measured using goniometer
|
Baseline and after 6 weeks
|
|
Neck Disability Index
Time Frame: baseline and after 6 weeks
|
The functions of neck was assessed using Neck Disability Index (NDI); The NDI is a 10-item patient-reported questionnaire designed to assess how neck pain affects daily activities such as personal care, lifting, reading, concentration, work, driving, sleeping, and recreation.
Each item is scored from 0 (no difficulty) to 5 (maximum difficulty), giving a total raw score ranging from 0 to 50.
The raw score is often converted to a percentage to standardize interpretation: NDI Percentage = (Total Score ÷ 50) × 100
|
baseline and after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saba Rafiq, PhD*, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Actual)
May 30, 2026
Study Completion (Actual)
June 30, 2026
Study Registration Dates
First Submitted
July 17, 2026
First Submitted That Met QC Criteria
July 17, 2026
First Posted (Actual)
July 22, 2026
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- REC/RCR&AHS/25/0144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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