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

NCT07270276 | Recruiting DMC FDA Device

• 2 other identifiers: 2025P000944R33AT012284
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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

Conditions

Trigger Point in Trapezius Muscle

Keywords

Myofascial Pain; Trigger Point; Myofascial Pain Syndrome; Trapezius Muscle Pain

Outcome Measures

Primary Outcomes (1)

• Excitability threshold tracking (TT)

  The secondary outcome will be maximum latency change with a conditioning stimulus

  From enrollment to end of treatment follow up (2 weeks)

Secondary Outcomes (3)

• Muscle ultrasound

  From enrollment to end of treatment follow up (approximately 2 weeks)

• Electrical Impedance Myography (EIM)

  From enrollment to end of treatment follow up (2 weeks)

• Algometer Measurement Device Output

  From enrollment to end of treatment follow up (2 weeks)

Study Arms (2)

Dry Needling Treatment Group

EXPERIMENTAL

Procedure: Dry Needling

Sham/Placebo Treatment Group

PLACEBO COMPARATOR

Procedure: Sham Treatment

Interventions

Dry Needling 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.

Dry Needling Treatment Group

Sham Treatment 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.

Sham/Placebo Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• SSRIs, such as citalopram, escitalopram, fluoxetine, sertraline,
• SNRIs, such as duloxetine, milnacipran, and venlafaxine
• Tricyclic antidepressants, such as notritptyline, amitriptyline, and desipramine
• Alpha 2 delta ligands: pregabalin, gabapentin
• Specific anti-epileptics: topiramate, lamotrigine, oxcarbazepine, and phenytoin
• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts General Hospital: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology Chair

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 8, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be available following completion of all planned analyses and manuscripts.
• Access Criteria: We will make the data and associated documentation available to a NIH HEAL Initiative approved Central Data Repository, such as Vivli.

Locations

US (2)