Dry Needling Combined With a Therapeutic Exercise Program in Myofascial Pain Syndrome: Sonographic Evaluation of Cervical Muscles

August 18, 2025 updated by: Muhammed Oğuz, Istanbul Training and Research Hospital

The Effect of Dry Needling of the Upper Trapezius Muscle Added to Therapeutic Exercise Therapy on the Thickness of the Cervical Muscles in Myofascial Pain Syndrome

Patients between the ages of 20-65 years who present to the Physical Medicine and Rehabilitation outpatient clinics of our hospital with complaints of back and neck pain and are diagnosed with myofascial pain syndrome will be referred to the physicians responsible for the study to be included in the study. Exclusion criteria will be reviewed, and patients with chronic pain for more than 3 months and an active trigger point in the unilateral upper trapezius muscle will be included in the study. Patients will be randomly divided into two groups; the first group will receive only exercise therapy (including cervical range of motion and trapezius stretching), and the second group will receive exercise and dry needling therapy (1 time per week, 3 sessions in total). Demographic data (age, gender, body mass index, occupation) of all patients included in the study will be recorded. The relationship between pain and loss of function according to the Visual Analog Scale (VAS), Short Form 36 (SF-36), and Neck Disability Index (NDI) scales will be recorded. Bilateral upper trapezius, sternocleidomastoideus, and total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus) and longus colli muscle thickness measurements will be made with the ultrasonography device in our clinic. The first group will receive only exercise therapy after the measurements. Patients in the second group will receive a total of 3 sessions of dry needling treatment to the trapezius muscle for active trigger points at 0, 1, and 2 weeks in addition to exercise therapy. After the initial examination, control VAS, SF-36, NDI, and control ultrasonographic measurements will be performed in all patients at the 3rd week and 6th week. Using data analysis methods, the effect of dry needling treatment for active trigger points in the trapezius muscle on pain and functionality as well as the thickness of the cervical muscles will be investigated.

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.
73

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
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Istanbul 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:

  • Patients aged 20-65 years with neck pain for more than 12 weeks
  • Active trigger point in the unilateral upper trapezius muscle on physical examination
  • Who agreed not to receive anti-inflammatory and myorelaxant treatment during the study period

Exclusion Criteria:

  • Patients diagnosed with rheumatologic diseases
  • Patients with radiculopathy
  • Patients with a history of previous surgery in the shoulder, back, and neck region
  • Patients with polyneuropathy
  • Patients with severe cervical spondylosis
  • Patients with cerebrovascular events
  • Patients with malignancies
  • Those with cognitive impairment
  • Those with bleeding disorders
  • Patients diagnosed with fibromyalgia
  • Patients with thyroidectomy
  • Anti-inflammatory-analgesic or myorelaxant treatment within the last 1 month
  • Patients with a history of injection into the upper trapezius muscle or cervical region within the last 3 months

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.
Active Comparator: Group 1: Therapeutic Exercise
Behavioral: Therapeutic Exercise Program
Participants in this group will receive a therapeutic exercise program (including cervical range of motion and trapezius stretching) during the study period.
Active Comparator: Group 2: Therapeutic Exercise and Dry Needling
Behavioral: Therapeutic Exercise Program
Participants in this group will receive a therapeutic exercise program (including cervical range of motion and trapezius stretching) during the study period.
Procedure: Dry Needling
Participants in this group will receive dry needling treatment for active trigger points in addition to the therapeutic exercise program. Dry needling treatment will be applied in a total of 3 sessions at 0, 1, and 2. weeks, one week apart.

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
Ultrasonographic evaluation for muscle thickness assessment
Time Frame: It will be evaluated in the baseline, third, and sixth weeks.
Bilateral upper trapezius, sternocleidomastoid, total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus), and longus colli muscle thickness measurements will be made with the ultrasonography device.
It will be evaluated in the baseline, third, and sixth 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
Pain will be assessed with Visual Analog Scale.
Time Frame: It will be evaluated in the baseline, third, and sixth weeks.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
It will be evaluated in the baseline, third, and sixth weeks.
Functional status will be assessed with the Neck Disability Index.
Time Frame: It will be evaluated in the baseline, third, and sixth weeks.
Neck Disability Index (NDI) consists of 10 questions in total. Each question receives a score ranging from 0 to 5. Totals can have a minimum score of 0 and a maximum score of 50. Higher scores indicate more severe disability.
It will be evaluated in the baseline, third, and sixth weeks.
General health status will be assessed with Short Form 36.
Time Frame: It will be evaluated in the baseline, third, and sixth weeks.
Short Form 36 (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
It will be evaluated in the baseline, third, and sixth 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.
Istanbul Training and Research Hospital

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: Muhammed Oğuz, Istanbul 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.
February 9, 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.
July 25, 2025

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.
August 15, 2025

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).
January 26, 2025

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.
January 30, 2025

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 5, 2025

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.
August 19, 2025

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.
August 18, 2025

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.
August 1, 2025

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.
  • 18/09/2024;2024-KAEK-30;114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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