- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06546124
Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome
January 26, 2026 updated by: Serdar Kilinc, Abant Izzet Baysal University
Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome: Comparison of Ultrasound- Guided Dry Needling Techniques
The aim of this study is to compare the effects of superficial and deep dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Myofascial Pain Syndrome (MAS) is a common condition encountered in the daily practice of musculoskeletal medicine.
Dry needling is a commonly used technique by clinicians in the treatment of myofascial trigger points.
Dry needling can be classified into two main categories based on the depth of needle insertion: superficial and deep dry needling.
Dry needling can be performed using either manual palpation techniques or ultrasonographic imaging.
Ultrasound allows for more precise needle placement.
It must be recognized that the depth of needling (superficial insertion vs. deep insertion) varies for every structure and that without ultrasound guidance, differentiation between needling into the superficial fascia and beyond the deep fascia maybe difficult.
In clinical settings, using ultrasound can help visualize the different layers and guide the needle to the appropriate depth.
The aim of this study is to compare the effectiveness of deep fascia and intramuscular trigger point dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.
Study Type
Interventional
Enrollment (Actual)
80
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
-
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Bolu, Turkey (Türkiye), 14100
- Abant Izzet Baysal University
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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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of MPS in the upper trapezius muscle in accordance with criteria defined by Travell and Simons
- Ages between 20 and 50 years
- No treatment, including injections, dry needling, and physical methods, applied to the cervical region in the last three months
Exclusion Criteria:
- Bleeding Tendency
- History of Neck and Shoulder Trauma
- Other Conditions Affecting Neck and Shoulder Pain: including malignancy, infection, rheumatic diseases, degenerative joint disease, fibromyalgia, cervical radiculopathy, neuropathy, myelopathy, myopathy, adhesive capsulitis, etc.
- Cases Where Evaluation Could Not Be Completed for Any Reason
- Patients Who Refuse to Complete the Evaluations
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Deep fascia dry needling technique
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"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally.
All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides.
A myofascial trigger point on the upper trapezius muscle will be marked.
A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used.
Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating subcutaneously to the deep fascia.
After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes.
The needles will be removed after a total of 10 minutes.
Participants will be advised to perform upper trapezius stretching exercises."
|
|
Active Comparator: İntramuscular trigger point dry needling technique
|
"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally.
All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides.
A myofascial trigger point on the upper trapezius muscle will be marked.
A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used.
Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating through the deep fascia into the upper trapezius muscle.
After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes.
The needles will be removed after a total of 10 minutes.
Participants will be advised to perform upper trapezius stretching exercises."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Numerical Pain Rating Scale
Time Frame: Before treatment
|
It is used to measure pain.
The numerical scale for perceived pain intensity usually includes 11 numbers.
The participant selects the number that best reflects their pain.
In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
|
Before treatment
|
|
The Numerical Pain Rating Scale
Time Frame: 1 week after treatment
|
It is used to measure pain.
The numerical scale for perceived pain intensity usually includes 11 numbers.
The participant selects the number that best reflects their pain.
In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.
|
1 week after treatment
|
|
Pressure Pain Threshold
Time Frame: Before treatment
|
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.
It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity.
The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf).
In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used.
The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation.
The average of these three measurements will be included in the evaluation.
|
Before treatment
|
|
Pressure Pain Threshold
Time Frame: 1 week after treatment
|
A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception.
It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity.
The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf).
In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used.
The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation.
The average of these three measurements will be included in the evaluation.
|
1 week after treatment
|
|
Neck disability index
Time Frame: Before treatment
|
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability.
This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities.
The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities.
Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter.
Each item is scored from 0 (no disability) to 5 (complete disability).
The total score ranges from 0 (no disability) to 50 (total disability).
After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment.
As the score increases, disability increases; as the score decreases, disability decreases.
|
Before treatment
|
|
Neck disability index
Time Frame: 1 week after treatment
|
The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability.
This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities.
The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities.
Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter.
Each item is scored from 0 (no disability) to 5 (complete disability).
The total score ranges from 0 (no disability) to 50 (total disability).
After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment.
As the score increases, disability increases; as the score decreases, disability decreases.
|
1 week after treatment
|
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Neck bournemouth questionnaire
Time Frame: Before treatment
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Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain.
The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies.
Each of the 7 questions is scored from 0 to 10.
The highest possible score is 70, with a higher score indicating a higher level of disability.
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Before treatment
|
|
Neck bournemouth questionnaire
Time Frame: 1 week after treatment
|
Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain.
The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies.
Each of the 7 questions is scored from 0 to 10.
The highest possible score is 70, with a higher score indicating a higher level of disability.
|
1 week after treatment
|
|
Joint range of Motion Measurement
Time Frame: Before treatment
|
Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method.
While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.
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Before treatment
|
|
Joint range of Motion Measurement
Time Frame: 1 week after treatment
|
Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method.
While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.
|
1 week after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Advers event
Time Frame: 1 week after treatment
|
Follow-up will include assessment of pain-burning sensation, nausea, dizziness, and pain experienced during the procedure.
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1 week after treatment
|
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Cutaneous and subcutaneous thickness
Time Frame: Before treatment
|
Cutaneous and subcutaneous tissue thickness will be measured with ultrasound at the site of the trigger point in the upper trapezius muscle.
|
Before treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 11, 2024
Primary Completion (Actual)
March 1, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
August 7, 2024
First Submitted That Met QC Criteria
August 7, 2024
First Posted (Actual)
August 9, 2024
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-SK-07
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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