NCT07270276 · Beth Israel Deaconess Medical Center
The Impact of Dry Needling on Electrophysiological and Ultrasound-based Biomarkers for Myofascial Pain
(ENCOMPASS-2)
What this study is about
The goal of this interventional study is to determine how well dry-needling can treat pain in people with Myofascial Pain Syndrome.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations