NCT05066529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

August 28, 2021

Last Update Submit

October 29, 2021

Conditions

Keywords

trigger pointdry-needlingultrasonographypain intensityneck disability

Outcome Measures

Primary Outcomes (5)

  • diameter of trigger point

    an ultrasonographic evaluation

    3 month follow-ups

  • circumference of trigger point

    an ultrasonographic evaluation

    3 month follow-ups

  • area of trigger point

    an ultrasonographic evaluation

    3 month follow-ups

  • Numerical Rating Scale

    a questionnaire to evaluate pain intensity

    3 month follow-ups

  • Neck Disability index

    a questionnaire to evaluate neck disability

    3 month follow-ups

Secondary Outcomes (1)

  • active servical range of motion

    3 month follow-ups

Study Arms (2)

dry-needling group

EXPERIMENTAL

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.

Procedure: dry-needling

exercise group

OTHER

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.

Procedure: dry-needling

Interventions

dry-needlingPROCEDURE

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.

Also known as: exercise
dry-needling groupexercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • trigger points in the upper trapezius muscle
  • years old
  • no treatment in three months for myofascial pain syndrome (MPS)
  • accept to participate treatment program

You may not qualify if:

  • already treated in 3 months for MPS
  • below 18 years and above 45 years old
  • no acceptance to participate the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Myofascial Pain SyndromesPain

Interventions

Dry NeedlingExercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Merve Damla Korkmaz

    Kanuni Sultan Suleyman Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All treatments will be applied by an investigator and a different blinded investigator will evaluate all participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 28, 2021

First Posted

October 4, 2021

Study Start

April 1, 2021

Primary Completion

September 30, 2021

Study Completion

October 30, 2021

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Locations