Trigger Point in Trapezius MuscleENCOMPASS-2NCT07270276
The Impact of Dry Needling on Electrophysiological and Ultrasound-based Biomarkers for Myofascial Pain
A study testing Dry Needling in people with Trigger Point in Trapezius Muscle, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigger Point in Trapezius Muscle
- What is being tested?
- Dry Needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2026to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brian Wainger, MD, PhD., 617-643-0399, lsams1@mgh.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Tatyana Okanlomo Clinical Research Coordinator, 617-667-3083, tokanlom@bidmc.harvard.edu
About this study
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?
Read more
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
Read the 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.
- 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:
- Trigger point will be identified in the trapezius muscle, and marked with a marker by a physician.
- 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
- 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.
- 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.
- Algometry - a controlled pressure will be applied to the trigger point to measure pain response. This will take 5 minutes.
- Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain, mood, and sleep.
- Dry needling treatment or sham procedure will be administered by a physician. This will take 5-10 minutes.
Home Period:
- 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.
- 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.
- Imaging and testing measures including EIM, TT, US, and algometry will be performed.
- Questionnaires taken at baseline, and two additional ones, will be administered.
- Adverse events and pain medication regimens will be reviewed.
- Conditions
- Trigger Point in Trapezius Muscle
- Being tested
- Dry Needling, Sham Treatment
- Keywords
- Myofascial Pain, Trigger Point, Myofascial Pain Syndrome, Trapezius Muscle Pain
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or 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 TreatmentProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Treatment Group | Experimental | Not described Receives: Procedure: Dry Needling |
| Sham/Placebo Treatment Group | Placebo comparator | Not described Receives: Procedure: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excitability threshold tracking (TT)
The secondary outcome will be maximum latency change with a conditioning stimulus
Measured: From enrollment to end of treatment follow up (2 weeks)
Secondary outcomes (3)
Muscle ultrasound
Echointensity
Measured: From enrollment to end of treatment follow up (approximately 2 weeks)
Electrical Impedance Myography (EIM)
The primary outcome will be 100 kHz phase angle in EIM
Measured: From enrollment to end of treatment follow up (2 weeks)
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.
Measured: From enrollment to end of treatment follow up (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Feb 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point in Trapezius MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Seward Rutkove, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270276
- Sponsor's protocol ID
- 2025P000944
- Other IDs
- R33AT012284
- Acronym
- ENCOMPASS-2
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A final, complete, cleaned, and coded study data set will be provided for public access including the appropriate data dictionaries and case report forms on the Vivli data repository platform.