Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
August 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJanuary 27, 2026
September 1, 2025
7 months
August 7, 2024
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (10)
The Numerical Pain Rating Scale
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
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
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
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
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
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
Neck bournemouth questionnaire
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.
Before treatment
Neck bournemouth questionnaire
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
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.
Before treatment
Joint range of Motion Measurement
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 Outcomes (2)
Advers event
1 week after treatment
Cutaneous and subcutaneous thickness
Before treatment
Study Arms (2)
Deep fascia dry needling technique
ACTIVE COMPARATORDeep fascia dry needling technique
İntramuscular trigger point dry needling technique
ACTIVE COMPARATORİntramuscular trigger point dry needling technique
Interventions
"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."
"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."
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abant Izzet Baysal University
Bolu, 14100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
August 7, 2024
First Posted
August 9, 2024
Study Start
August 11, 2024
Primary Completion
March 1, 2025
Study Completion
April 1, 2025
Last Updated
January 27, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share