Myofascial PainENCOMPASSNCT05793086
Evaluation of a Novel Class of Objective Myofascial Pain Assessments
An observational study of Myofascial Pain and Trigger Point Pain, Myofascial, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain, Trigger Point Pain, Myofascial
- What is being tested?
- Ultrasound, Electrical impedance myography and Excitability testing
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with myofascial pain syndrome with active and/or latent TrPs, as diagnosed by a pain specialist, with involvement of the trapezius meeting
Who may be able to join
- Ages: 18-80
- Myofascial Pain Syndrome with active and/or latent TrPs, as diagnosed by a pain specialist, with involvement of the trapezius meeting criteria (detailed in "Methods"))
- Capacity to manage breakthrough pain medications during the study with only acetaminophen
- 1. Ages: 18-80
Who cannot join
- Presence of radicular pain, superimposed neuromuscular disease, or condition
- Fibromyalgia or other generalized pain condition
- Opioid use
- Active mood or substance use disorder
- Taking or unable to wean off pain medications that directly affect neuronal or muscle excitability at least 2 weeks prior to study enrollment and remain off for the duration of the study: gabapentin, pregabalin, topiramate, carbamazepine, oxcarbazepine, valproic acid, tricyclic antidepressants (such as nortriptyline and amitriptyline), tizanidine, cyclobenzaprine, carisoprodol, methocarbamol, benzodiazepines
- Skin allergy or sensitivity that would preclude the use of adhesive electrodes
Show all 17Show fewer
- 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).
- Healthy volunteers
- Presence of radicular, myofascial, or generalized pain, superimposed neuromuscular disease or condition
- History of MPS, examination demonstrating trigger points
- Fibromyalgia or other generalized pain condition
- Opioid use
- Active mood or substance use disorder
- Taking or unable to wean off pain medications that directly affect neuronal or muscle excitability at least 2 weeks prior to study enrollment and remain off for the duration of the study: gabapentin, pregabalin, topiramate, carbamazepine, oxcarbazepine, valproic acid, tricyclic antidepressants (such as nortriptyline and amitriptyline), tizanidine, cyclobenzaprine, carisoprodol, methocarbamol, benzodiazepines
- Skin allergy or sensitivity that would preclude85 the use of adhesive electrodes
- Systemic or psychiatric illness that in the opinion of the Site Investigator would interfere with the individual's ability to participate in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Electrophysiological and Ultrasound Quantitative Biomarkers for Myofascial Pain
This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.
Read the detailed description
Study Visit One:
- Overview
- History and examination (All participants). After reviewing the purpose and procedures of the study, the subject, or a legally authorized representative (LAR), will be asked to sign the internal review board-approved informed consent form. Basic medical, social, and family histories will then be obtained and recorded. Previous medical records will be reviewed. Medications, including drug doses, history of recent medication changes, and duration of treatment) will be reviewed. A brief physical exam will be performed. If the subject has MPS, the study doctor will identify the trigger points and will mark those with a permanent marker.
- 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.
- Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain, mood, and sleep. Overall, this visit will take approximately 1 - 1.5 hours.
Home Period Subjects will be asked to re-inforce/re-apply the permanent marker spots made at their first visit. This is so investigators can use the same spots for testing at the next visit.
Study Visit 2 (2-14 days after Study Visit #1) The second study visit is identical to the first one. A study team member will test the subject's trigger points again at the beginning of the visit. This visit will also last approximately 1-1.5 hours.
- Conditions
- Myofascial Pain, Trigger Point Pain, Myofascial
- Being tested
- Ultrasound, Electrical impedance myography, Excitability testing
- Keywords
- Myofascial Pain, Trigger point
- 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.
UltrasoundDiagnostic test
Using shear wave elastography and gray scale analysis of ultrasound.
Electrical impedance myographyDiagnostic test
Measurement of localized bioimpedance of muscle
Excitability testingDiagnostic test
Electrical studies of myofiber excitability
| Study group | Role | What they receive |
|---|---|---|
| active trigger point group | Individuals with active trigger points in trapezius Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Electrical impedance myography; Diagnostic Test: Excitability testing | |
| latent trigger point group | Individuals with trigger points in trapezius without spontaneous pain Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Electrical impedance myography; Diagnostic Test: Excitability testing | |
| healthy trapezius muscle | Individuals without trigger points. Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Electrical impedance myography; Diagnostic Test: Excitability testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Electrical Impedance Myography (EIM)
The primary outcome will be 100 kHz phase angle in EIM
Measured: 2.5 years
Secondary outcomes (2)
Secondary outcome: Ultrasound with shear wave elastography (SWE)
echointensity and elastic modulus
Measured: 2.5 years
Secondary outcome: Excitability threshold tracking (TT)
The secondary outcome will be maximum latency change with a conditioning stimulus
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start27 Jan 2023
- Primary completion1 May 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Seward Rutkove, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793086
- Sponsor's protocol ID
- 2022P000543
- Acronym
- ENCOMPASS
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: When the project is finished and all primary analyses are complete, a final, complete, cleaned, and de-identified data set will be provided for public access including the appropriate data dictionaries and case report forms. In addition to the sharing of resources during the trial, the investigators of this study are fully committed to participate in data sharing as per NIH policies. Following completion of all planned analyses and manuscripts, investigators will make the data and associated documentation available to qualified users though repositories like the Biomedical Informatics Research Network (BIRN), which is capable of supporting large volumes of data (e.g. neuroimaging), and NIH HEAL Initiative Central Data Repository.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological and Ultrasound Quantitative Biomarkers for Myofascial Pain
- ClinicalTrials.gov ID
- NCT05793086
- Acronym / sponsor ID
- ENCOMPASS / 2022P000543
- Conditions
- Myofascial Pain, Trigger Point Pain, Myofascial
- Keywords
- Myofascial Pain, Trigger point
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.
Detailed description
Study Visit One:
- Overview
- History and examination (All participants). After reviewing the purpose and procedures of the study, the subject, or a legally authorized representative (LAR), will be asked to sign the internal review board-approved informed consent form. Basic medical, social, and family histories will then be obtained and recorded. Previous medical records will be reviewed. Medications, including drug doses, history of recent medication changes, and duration of treatment) will be reviewed. A brief physical exam will be performed. If the subject has MPS, the study doctor will identify the trigger points and will mark those with a permanent marker.
- 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.
- Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain, mood, and sleep. Overall, this visit will take approximately 1 - 1.5 hours.
Home Period Subjects will be asked to re-inforce/re-apply the permanent marker spots made at their first visit. This is so investigators can use the same spots for testing at the next visit.
Study Visit 2 (2-14 days after Study Visit #1) The second study visit is identical to the first one. A study team member will test the subject's trigger points again at the beginning of the visit. This visit will also last approximately 1-1.5 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active trigger point group | – | Diagnostic Test: Ultrasound, Diagnostic Test: Electrical impedance myography, Diagnostic Test: Excitability testingIndividuals with active trigger points in trapezius |
| latent trigger point group | – | Diagnostic Test: Ultrasound, Diagnostic Test: Electrical impedance myography, Diagnostic Test: Excitability testingIndividuals with trigger points in trapezius without spontaneous pain |
| healthy trapezius muscle | – | Diagnostic Test: Ultrasound, Diagnostic Test: Electrical impedance myography, Diagnostic Test: Excitability testingIndividuals without trigger points. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myofascial pain syndrome with active and/or latent TrPs, as diagnosed by a pain specialist, with involvement of the trapezius meeting
Key inclusion criteria (4 listed)
- Ages: 18-80
- Myofascial Pain Syndrome with active and/or latent TrPs, as diagnosed by a pain specialist, with involvement of the trapezius meeting criteria (detailed in "Methods"))
- Capacity to manage breakthrough pain medications during the study with only acetaminophen
- 1. Ages: 18-80
Key exclusion criteria (17 listed)
- Presence of radicular pain, superimposed neuromuscular disease, or condition
- Fibromyalgia or other generalized pain condition
- Opioid use
- Active mood or substance use disorder
- Taking or unable to wean off pain medications that directly affect neuronal or muscle excitability at least 2 weeks prior to study enrollment and remain off for the duration of the study: gabapentin, pregabalin, topiramate, carbamazepine, oxcarbazepine, valproic acid, tricyclic antidepressants (such as nortriptyline and amitriptyline), tizanidine, cyclobenzaprine, carisoprodol, methocarbamol, benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUsing shear wave elastography and gray scale analysis of ultrasound. | Diagnostic test | active trigger point group, healthy trapezius muscle, latent trigger point group |
| Electrical impedance myographyMeasurement of localized bioimpedance of muscle | Diagnostic test | active trigger point group, healthy trapezius muscle, latent trigger point group |
| Excitability testingElectrical studies of myofiber excitability | Diagnostic test | active trigger point group, healthy trapezius muscle, latent trigger point group |
Primary outcome
Primary outcome: Electrical Impedance Myography (EIM)
Time frame: 2.5 years
The primary outcome will be 100 kHz phase angle in EIM
2 secondary outcomes
Secondary outcome: Ultrasound with shear wave elastography (SWE)
Time frame: 2.5 years
Secondary outcome: Excitability threshold tracking (TT)
Time frame: 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. When the project is finished and all primary analyses are complete, a final, complete, cleaned, and de-identified data set will be provided for public access including the appropriate data dictionaries and case report forms. In addition to the sharing of resources during the trial, the investigators of this study are fully committed to participate in data sharing as per NIH policies. Following completion of all planned analyses and manuscripts, investigators will make the data and associated documentation available to qualified users though repositories like the Biomedical Informatics Research Network (BIRN), which is capable of supporting large volumes of data (e.g. neuroimaging), and NIH HEAL Initiative Central Data Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain and Trigger Point Pain, Myofascial, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Electrical Impedance Myography (EIM) (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.