COMPARISON OF THREE TREATMENT MODALITIES IN MYOFASCIAL PAIN SYNDROME (MPS-TREAT)

May 1, 2026 updated by: ALİEMAN

COMPARATIVE EFFECTIVENESS OFF DRY NEEDLING, EXTRACORPOREAL SHOCK WAVE THERAPY, AND TRANSCUTANEOUS PULSED RADIOFREQUENCY IN PATIENTS WITH MYOFASCIAL PAIN SYNDROME: A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL

This study aims to compare the effectiveness of dry needling, extracorporeal shock wave therapy (ESWT), and pulsed radiofrequency (PRF) in patients with chronic musculoskeletal pain. The primary outcomes include pain intensity and functional status. Patients will be randomly assigned to different treatment groups, and outcomes will be evaluated before and after the interventions. The results of this study are expected to contribute to determining the most effective treatment method for pain management.

Study Overview

Status

Status

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

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.

Detailed Description

Myofascial pain syndrome is a common musculoskeletal disorder characterized by trigger points and chronic pain. Various treatment modalities such as dry needling, extracorporeal shock wave therapy (ESWT), and pulsed radiofrequency (PRF) are used in clinical practice; however, there is no clear consensus on the most effective approach.

This randomized, parallel-group study aims to compare the effectiveness of these three treatment methods in patients diagnosed with myofascial pain syndrome. Eligible patients aged between 18 and 65 years with chronic back pain lasting at least 3 months will be included in the study. Participants will be randomly assigned to receive dry needling, ESWT, or PRF treatment.

Pain intensity will be assessed using the Numeric Rating Scale (NRS), and functional outcomes will also be evaluated. The study is expected to contribute to the current literature by providing comparative data on these commonly used treatment modalities and guiding clinical decision-making.

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 (Estimated)

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

  • Turkey (Türkiye)
    • Sakarya
      • Adapazarı, Sakarya, Turkey (Türkiye)
        • Recruiting
        • Sakarya Training and Research Hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Clinically diagnosed myofascial pain syndrome
  • Back pain lasting at least 3 months
  • Failure to respond to conservative treatments

Exclusion Criteria:

  • History of cervical surgery or cervical disc pathology
  • Fibromyalgia
  • Shoulder pathologies
  • Coagulation disorders or use of anticoagulant therapy
  • Infection, malignancy, or inflammatory spinal diseases

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: None (Open Label)

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: Dry Needling Group
Patients receiving dry needling treatment.
Procedure: Dry Needling
Dry needling applied to myofascial trigger points
Experimental: ESWT Group
Patients receiving extracorporeal shock wave therapy (ESWT)
Procedure: Extracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy applied to the painful area
Experimental: PRF Group
Patients receiving pulsed radiofrequency (PRF) treatment.
Procedure: Pulsed radiofrequency(PRF)
Pulsed radiofrequency applied to the target area for the treatment of myofascial pain syndrome

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: Baseline, 1 month, and 3 months after treatment
Pain intensity will be assessed using the Numeric Rating Scale(NRS). Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Baseline, 1 month, and 3 months after treatment

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
Time Frame: Baseline, 1 month, and 3 months after treatment
Pressure pain threshold will be measured using algometry. Pressure pain threshold will be measured using an algometer (kg/cm²). Higher values indicate lower pain sensitivity and improved clinical condition.
Baseline, 1 month, and 3 months after treatment
Neck Disability Index (NDI)
Time Frame: Baseline, 1 month, and 3 months after treatment
Functional status will be evaluated using the Neck Disability Index (NDI). Functional status will be assessed using the Neck Disability Index (NDI), with scores ranging from 0 to 50. Higher scores indicate greater functional impairment.
Baseline, 1 month, and 3 months after treatment
Quality of Life (SF-12
Time Frame: Baseline, 1 month, and 3 months after treatment
Quality of life will be assessed using the Short Form-12 (SF-12) questionnaire. The SF-12 includes physical and mental component summary scores, with higher scores indicating better health-related quality of life.
Baseline, 1 month, and 3 months after treatment

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.
ALİEMAN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KEMAL NAS, MD, Professor, Sakarya University Training and Research Hospital, Department of Algology
  • Study Chair: RIDVAN ISIK, MD, Sakarya University Training and Research Hospital, Department of Algology

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.
March 10, 2026

Primary Completion (Estimated)

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.
March 10, 2027

Study Completion (Estimated)

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.
March 10, 2027

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).
March 30, 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.
March 30, 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.
April 6, 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 7, 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 1, 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.
May 1, 2026

More Information

Terms related to this study

Keywords

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.
  • MAS-TEZ--2026

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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