- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06809790
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1: Therapeutic Exercise
|
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
|
Participants in this group will receive a therapeutic exercise program (including cervical range of motion and trapezius stretching) during the study period.
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
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
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.
Investigators
- 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)
February 9, 2025
Primary Completion (Actual)
July 25, 2025
Study Completion (Actual)
August 15, 2025
Study Registration Dates
First Submitted
January 26, 2025
First Submitted That Met QC Criteria
January 30, 2025
First Posted (Actual)
February 5, 2025
Study Record Updates
Last Update Posted (Actual)
August 19, 2025
Last Update Submitted That Met QC Criteria
August 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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