Dry Needling for Myofascial Pain Syndrome

May 26, 2023 updated by: Emre Ata, Assoc Prof, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

A Comparison for 3 Different Dry Needling Techniques for Myofacial Pain Syndrome Causing Servical Pain

Myofascial pain syndrome (MAS) is defined as a regional painful syndrome characterized by pain and tenderness in a muscle group or a muscle, a taut band within the muscle, pain reflected by pressing, and the presence of trigger points. It causes localized muscle pain in the shoulder and neck. The frequency of mas is around 12% in the normal population, and its frequency increases in those with chronic diseases. It is more common in the 30-60 age range and in the female population. Mechanical causes such as micro-macro trauma, nociceptive disorders, physical fatigue, psychological stress and genetic factors are blamed in its etiopathogenesis. Painful myofascial trigger points may occur by pressing on all muscles in the body, although it is more common in the trazius muscle, especially in those who work at a desk, who are constantly in a certain position, and who are sedentary. Myofascial trigger points are often detected by examination.

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

There is a difference between the pain, neck extension range of motion, neck functional status of 3 different dry needling methods used in routine treatment in patients with myofascial pain syndrome. The investigators set out by thinking which method is more appropriate to choose in our practice. When the investigators examined the literature, the investigators could not find a study comparing these methods. However, at the points where sham needling, lidocaine administration, ozone cost, kinesiotaping methods and dry needling are compared by using these methods separately, regardless of the method of dry needling, there is a significant improvement in functional status, pain score, attachments, improvement expenses in the range of motion. However, the investigators think that it will contribute to a study literature on the protection of these purposes more clearly.

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.
45

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Sultan 2. Abdulhamid Han 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Among the patients who applied to Sultan 2. Abdulhamid Han Hospital Physical Medicine and Rehabilitation Department and were diagnosed with myofascial pain syndrome
  • Decided to receive dry needling treatment
  • Between the ages of 18 and 65
  • At least 1 painful myofascial trigger point in the m.trapezius, m.levator scapula muscles
  • Patients with neck pain lasting less than 6 months

Exclusion Criteria:

  • Those with a history of cervical operation
  • Those who have a history of shoulder operation
  • Patients with radiculopathy as a result of the examination
  • Those who have been injected into the determined area in the last 3 months
  • Those diagnosed with fibromyalgia according to the 2018 fibromyalgia scale
  • Those with cervical disc herniation in the MR imaging taken within the last 1 year
  • Pregnant/pregnant women
  • Those who are allergic to silver
  • Those with a history of malignancy
  • Those with positive red flags
  • Those with known rheumatological disease
  • Those who do not accept dry needling
  • Those with cognitive impairment
  • Those who have local infection in the application area

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: None (Open Label)

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.
Active Comparator: Group 1
Dry needling + standard exercise program with 4 sessions of stick and pull out method at 1 week intervals
Other: Group 1: Peppering
Before injection we will palpate the muscles of trapezius, m. rhomboideus, m. levator scapula for finding painful trigger points, and we will mark the point. the skin will be cleaned with an appropriate antiseptic. Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers. The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x25 mm needles will be used for dry needling. The needle will be inserted and removed until the local twitch response disappears, at least 10 times at each point found. Afterwards, the patient will be given a standard exercise program for the neck muscles. With this method, dry needling will be applied to the patient 4 times a week, once a week.
Active Comparator: Group 2
Dry needling + standard exercise program with 4 sessions of turn-and-wait method at 1-week intervals
Other: group 2: spin and wait
Just before the injection, painful trigger points in the bilateral muscles of trapezius, m. rhomboideus, and m. levator scapula will be identified and marked by palpation, and the skin will be cleaned with an appropriate antiseptic. Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers. The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x25 mm needles will be used for dry needling. After the dry needle is inserted at each point found, it will be spinned counterclockwise and left. Waiting time for each patient will be limited to 15 minutes. Afterwards, the patient will be given a standard exercise program for the neck muscles. With this method, dry needling will be applied to the patient 4 times a week, once a week.
Active Comparator: Group 3
Dry needling + standard exercise program with 4 sessions of stick and turn and wait method 1-week intervals
Other: group 3: Peppering and spin and wait
Just before the injection, painful trigger points in the bilateral muscles of trapezius, m. rhomboideus, and m. levator scapul will be identified and marked with palpation, and the skin will be cleaned with an appropriate antiseptic. Before the needle is inserted, the area to be applied will be palpated once again to detect the painful trigger point between the thumb and index fingers. The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x25 mm needles will be used for dry needling. After the needle is inserted and removed, it will be spinned counterclockwise for 15 minutes in each patient until the local twitch response disappears, at least 10 times at each point found. Afterwards, the patient will be given a standard exercise program. With this method, dry needling will be applied to the patient 4 times a week, once a week.

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
Visuel Analog Scale
Time Frame: one month
It is used to convert some values that cannot be measured numerically into numeric. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
one month

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
Neck Disability Index
Time Frame: one month
It is a questionnaire consisting of 10 questions and questions how neck pain affects the patient's ability to perform daily life activities such as sleep, personal care, driving, reading, and concentration. Each question is answered between 0-5 points. The minimum score can be 0, the maximum score can be 50. 0-4 points: no disability 5-14 points: mild disability 15-24 points: moderate disability 25-34 points: severe disability A score of 35 and above means complete disability
one month
European Quality of Life 5 Dimensions 3 Level Version
Time Frame: One month
It is a scale developed to evaluate health-related quality of life. It consists of two parts; one . The department defines the health profile in 5 dimensions (mobility, self-care, social life, pain, psychological state). Each dimension contains three statements according to the degree of difficulty (1: some problem, 2: moderate, 3: a lot of problems), the second part includes a visual analog scale (VAS) on which respondents rate their current health status from 0 to 100. It is easy to apply and is completed in a short time. 100 describes best functional stiuation, 0 describes worst developed to evaluate health-related quality of life.
One month

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.
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.
  • Principal Investigator: Emre Ata, Ass.Prof., Sultan II. Abdulhamidhan 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.
January 1, 2023

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.
February 15, 2023

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.
April 15, 2023

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).
December 6, 2022

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.
December 19, 2022

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.
December 30, 2022

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.
May 30, 2023

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.
May 26, 2023

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.
May 1, 2023

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.
  • 2270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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