Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome

October 29, 2021 updated by: Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: dry-needling
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:
  • exercise
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.
Procedure: dry-needling
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:
  • exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
an ultrasonographic evaluation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAEK/2021.03.88

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

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

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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