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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combined treatment
Other: 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
Other: Conventional treatment
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
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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