- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05066529
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome-single Blind Randomized Controlled Trial
The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.
64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.
Methods: 64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.
All treatments will be applied by an investigator and a different blinded investigator will evaluated all participants. Numerical Rating Scale will be used for evaluating pain intensity and Neck Disability Index will be used for evaluating neck disability.
Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.)
All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34303
- Kanuni Sultan Suleyman Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- trigger points in the upper trapezius muscle
- 18-45 years old
- no treatment in three months for myofascial pain syndrome (MPS)
- accept to participate treatment program
Exclusion Criteria:
- already treated in 3 months for MPS
- below 18 years and above 45 years old
- no acceptance to participate the trial
Study Plan
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 |
|---|---|
|
Experimental: dry-needling group
32 participants in this group Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.) All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups. |
Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia.
Treatment is often used to treat myofascial trigger points.
Other Names:
|
|
Other: exercise group
32 participants in this group Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.) All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups. |
Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia.
Treatment is often used to treat myofascial trigger points.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
diameter of trigger point
Time Frame: 3 month follow-ups
|
an ultrasonographic evaluation
|
3 month follow-ups
|
|
circumference of trigger point
Time Frame: 3 month follow-ups
|
an ultrasonographic evaluation
|
3 month follow-ups
|
|
area of trigger point
Time Frame: 3 month follow-ups
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an ultrasonographic evaluation
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3 month follow-ups
|
|
Numerical Rating Scale
Time Frame: 3 month follow-ups
|
a questionnaire to evaluate pain intensity
|
3 month follow-ups
|
|
Neck Disability index
Time Frame: 3 month follow-ups
|
a questionnaire to evaluate neck disability
|
3 month follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
active servical range of motion
Time Frame: 3 month follow-ups
|
active servical range of motion
|
3 month follow-ups
|
Collaborators and Investigators
Investigators
- Study Director: Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
Publications and helpful links
General Publications
- Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.
- Gerber LH, Shah J, Rosenberger W, Armstrong K, Turo D, Otto P, Heimur J, Thaker N, Sikdar S. Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain. PM R. 2015 Jul;7(7):711-718. doi: 10.1016/j.pmrj.2015.01.020. Epub 2015 Feb 4.
- Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK/2021.03.88
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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