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Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome

Primary Purpose

Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
dry-needling
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring trigger point, dry-needling, ultrasonography, pain intensity, neck disability

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kanuni Sultan Suleyman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

dry-needling group

exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

diameter of trigger point
an ultrasonographic evaluation
circumference of trigger point
an ultrasonographic evaluation
area of trigger point
an ultrasonographic evaluation
Numerical Rating Scale
a questionnaire to evaluate pain intensity
Neck Disability index
a questionnaire to evaluate neck disability

Secondary Outcome Measures

active servical range of motion
active servical range of motion

Full Information

First Posted
August 28, 2021
Last Updated
October 29, 2021
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05066529
Brief Title
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome
Official Title
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome-single Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial
Keywords
trigger point, dry-needling, ultrasonography, pain intensity, neck disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
All treatments will be applied by an investigator and a different blinded investigator will evaluate all participants
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dry-needling group
Arm Type
Experimental
Arm Description
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.
Arm Title
exercise group
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
dry-needling
Other Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
diameter of trigger point
Description
an ultrasonographic evaluation
Time Frame
3 month follow-ups
Title
circumference of trigger point
Description
an ultrasonographic evaluation
Time Frame
3 month follow-ups
Title
area of trigger point
Description
an ultrasonographic evaluation
Time Frame
3 month follow-ups
Title
Numerical Rating Scale
Description
a questionnaire to evaluate pain intensity
Time Frame
3 month follow-ups
Title
Neck Disability index
Description
a questionnaire to evaluate neck disability
Time Frame
3 month follow-ups
Secondary Outcome Measure Information:
Title
active servical range of motion
Description
active servical range of motion
Time Frame
3 month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Damla Korkmaz
Organizational Affiliation
Kanuni Sultan Suleyman Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28158962
Citation
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.
Results Reference
result
PubMed Identifier
25661462
Citation
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.
Results Reference
result
PubMed Identifier
29167092
Citation
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.
Results Reference
result

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Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome

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