- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413770
Comparison of Treatment Modalities in Myofascial Pain Syndrome
May 16, 2026 updated by: Begum Kara Kaya, Biruni University
Effects of Classical Massage in Individuals With Myofascial Pain Syndrome: A Randomized Controlled Trial
The aim of this study is to evaluate the effects of classical massage on pain, muscle sensitivity, muscle activity, functional status, and quality of life in individuals with myofascial pain syndrome, and to compare the effectiveness of classical massage applied alone versus in combination with a conventional physiotherapy program.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Istanbul, Turkey (Türkiye)
- Biruni University
-
-
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:
- Diagnosis of myofascial pain syndrome confirmed by a physical medicine and rehabilitation physician, according to the criteria of Travell and Simons (1992)
- Male or female participants aged 30-50 years
- Presence of at least one active trigger point in the upper trapezius muscle confirmed by palpation
- Pain radiating to the neck and upper extremity persisting for at least 3 months
- Pain intensity of ≥4/10 on the Visual Analog Scale (VAS)
- Functional impairment indicated by a Neck Disability Index (NDI) score ≥10/50 (≥20%)
- Written informed consent
Exclusion Criteria:
- Presence of diagnosed systemic musculoskeletal or rheumatologic disorders (e.g., fibromyalgia, rheumatoid arthritis)
- Signs or symptoms of neuropathic pain or cervical radiculopathy
- Conditions contraindicating massage therapy (e.g., skin infection, open wounds, bleeding disorders, active inflammation)
- Receipt of manual therapy, massage, dry needling, injections, or similar treatments targeting the affected region within the preceding 1 month
- Pregnancy or breastfeeding
- History of acute trauma, fracture, or surgical intervention involving the neck or shoulder region
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Combined treatment
|
Participants in this group will receive a combined intervention consisting of a conventional physiotherapy program together with a 20-minute therapeutic massage applied to the neck and upper back muscles (erector spinae, upper and middle trapezius, and levator scapulae), delivered according to Swedish massage principles, including effleurage, kneading, and deep friction techniques targeting active trigger points.
|
|
Experimental: Conventional Physiotherapy
|
Participants inthis group will receive a conventional physiotherapy program consisting of moist heat application for 15 minutes, pain-limited static stretching of the upper trapezius muscle (30-second stretch with 10-second rest, repeated five times), electrotherapy modalities (TENS, ultrasound, and infrared therapy), and postural education with a home exercise program for approximately 10 minutes.
|
|
Experimental: Therapeutic massage
|
Participants in this group will receive a 20-minute therapeutic massage intervention identical in technique and sequence to the massage component applied in combined group, targeting the neck and upper back muscles using Swedish massage techniques, without additional conventional physiotherapy modalities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 6 weeks
|
The primary outcome of this study is pain intensity, will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold-Algometer
Time Frame: 6 weeks
|
Muscle sensitivity will be evaluated using a pressure algometer applied over the upper trapezius trigger point, where higher values indicate reduced tenderness.
Results will be recorded in kg/cm².
|
6 weeks
|
|
Muscle Activity
Time Frame: 6 weeks
|
Muscle activity will be evaluated using surface electromyography (EMG) through root mean square (RMS) values recorded at rest and during 90 degrees of shoulder abduction.
Higher RMS values indicate greater muscle activation.
Results will ve recorded in µV.
|
6 weeks
|
|
Functional Status (Neck Disability Index)
Time Frame: 6 weeks
|
Functional disability related to neck pain will be evaluated using the Neck Disability Index (NDI).
Total score ranges from 0 to 50; higher scores indicate greater disability.
Lower scores reflect improved functional status.
|
6 weeks
|
|
Quality of Life (SF-12)
Time Frame: 6 weeks
|
Health-related quality of life will be assessed using the Short Form-12 questionnaire.
Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Higher scores indicate better quality of life.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 29, 2025
Primary Completion (Actual)
February 20, 2026
Study Completion (Actual)
February 20, 2026
Study Registration Dates
First Submitted
February 8, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 16, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Rheumatic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Fibromyalgia
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Combined Modality Therapy
- Massage
Other Study ID Numbers
- YL_MAS
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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