Myofascial PainNCT04929171
Myofascial Pain and Central Sensitization
An observational study of Myofascial Pain and Physical Therapy, run by University of Michigan at 1 site in United States.
Trial summary
This prospective, observational cohort pilot study compared pain phenotyping and functional measures in 30 participants with non-acute neck and/or shoulder girdle pain consistent with primary myofascial pain at 3-months following a physical therapy referral to study the impact of their baseline degree of pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain, Physical Therapy
- What is being tested?
- Physical Therapy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2016to 23 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were drawn from new patients evaluated at a tertiary care spine and musculoskeletal clinic.
Who may be able to join
- English-speaking participants
- Diagnosed by their physician with non-acute (more than two weeks) neck and/or shoulder girdle primary myofascial pain
- Referred to a physical therapy treatment.
Who cannot join
- In an effort to reduce the potential that another medical condition could lead to a secondary myofascial pain response, extensive comorbid exclusion criterion.
- Use of chronic high-dose opioid medication greater than 100 mg oral morphine equivalents per day.
- Individuals receiving or applying for compensation or disability.
- The inability to provide informed consent.
- Severe physical impairment (e.g., blindness, deafness)
- Co-morbid medical condition limiting function (e.g., malignant cancer)
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- Reported illicit drug use
- Severe psychiatric condition that would limit judgment.
- Lack of internet access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Nociplastic Pain Features on the Response to Physical Therapy in Patients With Primary Myofascial Pain: A Pilot Study.
This prospective, observational cohort pilot study compared pain phenotyping and functional measures in 30 participants with non-acute neck and/or shoulder girdle pain consistent with primary myofascial pain at 3-months following a physical therapy referral to study the impact of their baseline degree of pain amplification.
- Conditions
- Myofascial Pain, Physical Therapy
- Being tested
- Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Physical therapy for chronic upper quarter myofascial pain syndrome, as prescribed by the patients' physicians
| Study group | Role | What they receive |
|---|---|---|
| Patients with myofascial pain having centralized pain features | Adult patients with myofascial pain having centralized pain features who will be undergoing physical therapy Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Disability Index
Function neck scale with a total possible score of 50 indicating worse function compared to a score of 0.
Measured: Baseline to 3 months
Secondary outcomes (1)
Change in PEG Score
Multidimensional measure for initial assessment and follow-up of chronic pain in a primary care setting. The average of 3 domains with an averaged score of 0 to 10; 0 means lower pain interference and 10 means higher pain interference with life.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start2 May 2016
- Primary completion23 Nov 2019
- Study completion23 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kohns, University of Michigan
- Investigators
- David J Kohnsd, DO, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929171
- Sponsor's protocol ID
- HUM00093722
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2021
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kohns DJ, Scott R, Castellanos J, Scribner D, Hodges R, Clauw DJ. The impact of nociplastic pain features on the response to physical therapy in patients with primary myofascial pain. J Back Musculoskelet Rehabil. 2022;35(5):1143-1151. doi: 10.3233/BMR-210244.
PubMed 35213348
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nociplastic Pain Features on the Response to Physical Therapy in Patients With Primary Myofascial Pain: A Pilot Study.
- ClinicalTrials.gov ID
- NCT04929171
- Acronym / sponsor ID
- HUM00093722
- Conditions
- Myofascial Pain, Physical Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- 23 Nov 2019 (actual)
- First posted
- 18 Jun 2021 (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 prospective, observational cohort pilot study compared pain phenotyping and functional measures in 30 participants with non-acute neck and/or shoulder girdle pain consistent with primary myofascial pain at 3-months following a physical therapy referral to study the impact of their baseline degree of pain amplification.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with myofascial pain having centralized pain features | – | Other: Physical TherapyAdult patients with myofascial pain having centralized pain features who will be undergoing physical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were drawn from new patients evaluated at a tertiary care spine and musculoskeletal clinic.
Key inclusion criteria (3 listed)
- English-speaking participants
- Diagnosed by their physician with non-acute (more than two weeks) neck and/or shoulder girdle primary myofascial pain
- Referred to a physical therapy treatment.
Key exclusion criteria (9 listed)
- In an effort to reduce the potential that another medical condition could lead to a secondary myofascial pain response, extensive comorbid exclusion criterion.
- Use of chronic high-dose opioid medication greater than 100 mg oral morphine equivalents per day.
- Individuals receiving or applying for compensation or disability.
- The inability to provide informed consent.
- Severe physical impairment (e.g., blindness, deafness)
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 |
|---|---|---|
| Physical TherapyPhysical therapy for chronic upper quarter myofascial pain syndrome, as prescribed by the patients' physicians | Other | Patients with myofascial pain having centralized pain features |
Primary outcome
Change in Neck Disability Index
Time frame: Baseline to 3 months
Function neck scale with a total possible score of 50 indicating worse function compared to a score of 0.
1 secondary outcome
Change in PEG Score
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Results publication: PubMed 35213348Kohns DJ, Scott R, Castellanos J, Scribner D, Hodges R, Clauw DJ. The impact of nociplastic pain features on the response to physical therapy in patients with primary myofascial pain. J Back Musculoskelet Rehabil. 2022;35(5):1143-1151. doi: 10.3233/BMR-210244.
- Individual participant dataSharing planned: No
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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.
David J Kohnsd, DO principal investigator
University of Michigan
1 site 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 Physical Therapy, run by University of Michigan at 1 site 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Neck Disability Index (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929171, which also lists 1 linked publication.
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 17 Sep 2025.