The Impact of Dry Needling on Electrophysiological and Ultrasound-based Biomarkers for Myofascial Pain
Recruiting · NCT07270276 · Interventional (participants receive a specific treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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:
- 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)
- 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
Where it is running
2 locations listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States