The Impact of Dry Needling on Electrophysiological and Ultrasound-based Biomarkers for Myofascial Pain

NCT ID: NCT07270276

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2028-08-31

Brief Summary

The goal of this interventional study is to determine how well dry-needling can treat pain in people with Myofascial Pain Syndrome. The main questions it aims to answer are:

• Does dry needling improve pain for people with a trigger point (a tender, tight spot in the muscle)?
• How well can Electrical Impedence Myography (EIM), Myofiber Threshold Tracking (TT), and Ultrasound (US) detect changes in the muscle related to dry needling treatment?

Researchers will compare dry needling to a placebo (a treatment that does not enter the trigger point) to see if dry needling works to treat Myofascial Pain Syndrome with trigger points in the trapezius muscle (the muscle that extends over the back of the neck and shoulders), as measured by these three outcome measures (EIM, US, TT).

Participants will:

• Visit the clinic twice: once to receive dry needling treatment, and once for a follow-up
• Have muscle measurements taken before treatment and at follow-up
• Have a daily survey to record the intensity of their pain

Detailed Description

Pre-Screening:

Participants will be pre-screened to assess eligibility. The questionnaire can be completed on the phone, online in a survey, or in person. Medical records will also be reviewed. Eligible participants will schedule an on-site visit.

Study Visit #1:

In most cases the following sessions will occur on one day, unless due to scheduling conflicts separate sessions must be scheduled.

1. Eligibility & Screening: Baseline review of medical history and medication will be done to ensure eligibility. Informed consent will be taken from participants. Demographic data will be taken. This will take approximately one hour.

The following baseline procedures will occur:

2. Trigger point will be identified in the trapezius muscle, and marked with a marker by a physician.

3. Electrical Impedance Myography (EIM) - a trained technician will apply several small sticky pads (electrodes) to different parts of the subject's muscle and a very tiny electrical current will be applied that they will not feel. Several measurements will be done their muscle. This will take approximately 10 minutes

4. Ultrasound (US) - a trained technician will apply a small amount of gel to the skin. They will hold a small hand-held device on the skin and will measure the muscle. The gel is easily cleaned off of the skin when the testing is complete. This will take approximately 20 minutes.

5. Threshold Tracking (TT) - TT tests how quickly muscle responds to stimulation. The muscle is stimulated using a small needle which is placed superficially in their trapezius muscle. The subject will feel a small needle prick which should be less uncomfortable than having blood drawn. Electrodes (small sticky pads) are placed a short distance from the needle over the muscle. When their muscle is stimulated with the needle, the time it takes for the muscle to react is measured by the electrodes. This procedure will last 30 minutes and creates a tingling feeling.

6. Algometry - a controlled pressure will be applied to the trigger point to measure pain response. This will take 5 minutes.

7. Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain, mood, and sleep.

8. Dry needling treatment or sham procedure will be administered by a physician. This will take 5-10 minutes.

Home Period:

1. Subjects will be asked to re-apply the marker spot made at their first visit as it fades. This is so investigators can use the same spot for testing at the next visit.

2. A pain survey will be taken daily either online, by phone, or on paper.

Study Visit #2:

This visit will occur approximately two weeks after the intervention. It will take around 2 hours.

1. Imaging and testing measures including EIM, TT, US, and algometry will be performed.

2. Questionnaires taken at baseline, and two additional ones, will be administered.

3. Adverse events and pain medication regimens will be reviewed.

Conditions

Trigger Point in Trapezius Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dry Needling Treatment Group

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: PROCEDURE

A physical therapy and pain management technique where a small is inserted into a trigger point (tight, tender spots in the muscle that cause pain) and maneuvered to provide pain relief.

Sham/Placebo Treatment Group

Group Type: PLACEBO_COMPARATOR

Sham Treatment

Intervention Type: PROCEDURE

Treatment where a sham treatment will be administered which does not directly target the trigger point. Subjects will not be able to tell the difference between dry needling and sham treatment.

Interventions

Dry Needling

A physical therapy and pain management technique where a small is inserted into a trigger point (tight, tender spots in the muscle that cause pain) and maneuvered to provide pain relief.

Intervention Type: PROCEDURE

Sham Treatment

Treatment where a sham treatment will be administered which does not directly target the trigger point. Subjects will not be able to tell the difference between dry needling and sham treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ages 18-80
• Presence of active trigger points with involvement of upper trapezius
• Able to manage breakthrough pain with acetaminophen only, excluding stable doses of pain medications at time of enrollment, which can be continued

Exclusion Criteria

• Multiple active trigger points in the trapezius muscle if physician assessment concludes that this may interfere with subject's ability to detect changes in pain improvement from trigger point therapy
• Presence of cervical radicular pain, superimposed neuromuscular disease or condition that, in the opinion of the investigator, could confound interpretation of the data acquired from trapezius.
• Fibromyalgia or other generalized pain condition
• Opioid usage in the past 3 months
• Active substance use disorder
• Not on a stable dose for at least two weeks prior to study enrollment or unwilling to maintain a stable dose for duration of the study of the following drugs:

1. SSRIs, such as citalopram, escitalopram, fluoxetine, sertraline,

2. SNRIs, such as duloxetine, milnacipran, and venlafaxine

3. Tricyclic antidepressants, such as notritptyline, amitriptyline, and desipramine

4. Alpha 2 delta ligands: pregabalin, gabapentin

5. Specific anti-epileptics: topiramate, lamotrigine, oxcarbazepine, and phenytoin

6. Other: quinidine, mexiletine, and dalfampridine

• Skin allergy or sensitivity that would preclude the use of adhesive electrodes
• Significant systemic or psychiatric illness that in the opinion of the site Investigator would interfere with the individual's ability to participate in the trial
• Anticoagulation (with coumadin, clopidogrel, or direct oral anticoagulants; aspirin acceptable)
• TrP needle-based therapy in the past six weeks of the TrP to be studied
• Body mass index > 35 kg/m2
• Other factor that in the opinion of the site investigator would interfere with the ability to perform the study procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seward Rutkove

Department of Neurology Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Facility Contacts

Brian Wainger, MD, PhD.

Role: primary

lsams1@mgh.harvard.edu

617-643-0399

Clinical Research Coordinator

Role: primary

tokanlom@bidmc.harvard.edu

617-667-3083

Other Identifiers

R33AT012284

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P000944

Identifier Type: -

Identifier Source: org_study_id