Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome

March 18, 2026 updated by: Eren Başıbüyük
This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Another objective of this study was to evaluate and compare the short-term and long-term effectiveness of interfascial block, dry needling, and exercise therapies on pain, disability, and quality of life in patients with myofascial pain syndrome. In this respect, our study is important in terms of its contribution to the literature.

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

The study will include patients who present to the Physical Medicine and Rehabilitation outpatient clinic between July 2025 and May 2026 with clinical symptoms consistent with myofascial pain syndrome in the trapezius muscle. Patients referred to our injection clinic (treatment room) for routine myofascial stretching exercises, dry needling, and interfascial block treatments will be included if they meet the inclusion and exclusion criteria specified below. Demographic data such as age, gender, height, and weight will be recorded. At the initial assessment, patients' VAS (Visual Analog Scale), range of motion in the neck, neck disability scale, pressure pain threshold (PPT) measurements with an algometer, central sensitization scale, and Short Form 12 (SF-12) results will be noted. A total of 78 patients will be included in the study and randomly divided into three groups: Group 1 (Exercise group), Group 2 (Exercise + dry needling group), and Group 3 (Exercise + interfascial block group). Randomization will be done using a sealed envelope method. Group 1 will perform cervical ROM and trapezius facial stretching exercises. Group 2 will perform cervical ROM, trapezius facial stretching exercises, and dry needling of the relevant fascia using Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance. Group 3 will perform cervical ROM and trapezius facial stretching exercises, and interfascial application of a mixture of 1 cc of 2% lidocaine and 4 cc of 0.9% saline under ultrasound guidance. Patients will receive a total of 3 treatment sessions, once a week for 3 weeks. All evaluation parameters will be performed before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment. Within-group and between-group differences will be examined statistically.

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.
78

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 Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34668
        • Recruiting
        • Haydarpaşa Training and Research Hospital
        • Contact:

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:

  • Myofascial pain in the upper trapezius muscle that has lasted for at least 3 months
  • VAS score of 4 or higher for the current pain
  • Clinically diagnosed with myofascial pain in the trapezius muscle
  • Ages 18 to 55
  • Patients who can follow verbal instructions and have no cognitive deficits

Exclusion Criteria:

  • Having received interventional injections in the neck and shoulder area within the last 3 months
  • Having received physical therapy within the last 3 months
  • Having received regular nonsteroidal anti-inflammatory and myorelaxant treatment within the last month
  • History of surgery on the affected side (neck or shoulder)
  • Chronic inflammatory disease
  • Acute infection
  • History of malignancy
  • Coagulation disorders
  • Pregnancy
  • Liver and kidney pathologies
  • Drug allergy

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: Exercise group
Other: Exercise
Cervical range of motion and trapezius fascial stretching exercises
Experimental: Exercise + Dry Needling Group
Other: Dry Needling + Exercise
Cervical ROM, fascial stretching exercises for the trapezius muscles, and dry needling of the relevant fascia with Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance.
Experimental: Exercise + interfascial block group
Other: Exercise + interfascial block
Cervical range of motion (ROM) and trapezius muscles are treated with fascial stretching exercises and ultrasound-guided interfascial injection of 1 cc of 2% lidocaine + 4 cc of 0.9% saline solution.

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
Visual Analog Scale
Time Frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
0-10 scale. Higher scores represent more severe pain.
before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Cervical Range of Motion
Time Frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees.
before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Neck Disability Index (NDI)
Time Frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
The Neck Disability Index (NDI) is a widely used self-report questionnaire that measures functional disability associated with neck pain. It consists of 10 items scored from 0 to 5, covering pain intensity and daily activities. Higher scores indicate greater disability. The NDI is commonly used in clinical practice and research to assess baseline status and monitor treatment outcomes.
before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Pressure Pain Threshold (PPT)
Time Frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Pressure Pain Threshold (PPT) is a quantitative measure of pain sensitivity assessed using a pressure algometer. It represents the minimum amount of pressure that evokes pain. PPT is widely used in clinical and research settings to evaluate mechanical pain sensitivity, detect hyperalgesia, and monitor treatment effects. Lower PPT values indicate increased pain sensitivity, while higher values reflect reduced sensitivity.
before treatment, 30 minutes after the last session, and 12 weeks after the start of 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
12-Item Short Form Survey (SF-12)
Time Frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
The 12-Item Short Form Survey (SF-12) is a brief, validated questionnaire used to assess overall health-related quality of life. It measures physical and mental health through 12 questions derived from the SF-36. The survey generates two main scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better health status. The SF-12 is widely used in clinical practice and research due to its brevity, reliability, and ability to capture general functional health.
before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
Central Sensitisation Inventory
Time Frame: before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.
A self-report inventory, the Central Sensitization Inventory (CSI), will be used to assess the overlapping symptom dimensions of Central Sensitivity Syndromes. This measure is intended as a screening instrument to help identify the presence of a Central Sensitivity Syndrome, and to alert clinicians that presenting symptoms may be related to central sensitisation. Part A of the Central Sensitisation Inventory assesses 25 health-related symptoms that are common to Central Sensitivity Syndrome, with total scores ranging from 0-100. Part B (which is not scored) asks if one has previously been diagnosed with one or more specific disorders, including seven separate Central Sensitivity Syndromes
before treatment, 30 minutes after the last session, and 12 weeks after the start of 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.
Eren Başıbüyük

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.
  • Study Director: Sibel Süzen Özbayrak, Haydarpasa Numune Training and Research Hospital

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.
August 1, 2025

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.
August 1, 2026

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.
October 1, 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).
March 18, 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 18, 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.
March 24, 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.
March 24, 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.
March 18, 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

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.
  • 2024KAEK18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Safety concerns

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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