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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeth Israel Deaconess Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dry Needling

    Procedure/Surgery

    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 Treatment

    Procedure/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Dry Needling Treatment GroupExperimental treatment 1 intervention
Group B: Sham/Placebo Treatment GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Excitability threshold tracking (TT)

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

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

Secondary outcomes

1

Muscle ultrasound

Echointensity

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

Electrical Impedance Myography (EIM)

The primary outcome will be 100 kHz phase angle in EIM

Time frame
From enrollment to end of treatment follow up (2 weeks)
3

Algometer Measurement Device Output

The algometer is a simple pressure measurement tool which is placed directly over the trigger point. The examiner pushes down on the algometer, gradually increasing the pressure applied. The participant than verbally tells the examiner when they feel pain; the procedure is then terminated, and the examiner records the algometer pressure (measured in kg/cm\^2) at the instant of pain as the result. A lower value indicates greater pain sensitivity.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Massachusetts General Hospital

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator