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CompletedNCT04929171Updated Sep 17, 2025

Myofascial Pain and Central Sensitization

An observational study in Myofascial Pain and Physical Therapy, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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 amplification.

02

Conditions studied

  • Myofascial Pain
  • Physical Therapy
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants were drawn from new patients evaluated at a tertiary care spine and musculoskeletal clinic.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Reported illicit drug use
  • Severe psychiatric condition that would limit judgment.
  • Lack of internet access.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with myofascial pain having centralized pain features

    Adult patients with myofascial pain having centralized pain features who will be undergoing physical therapy

    Other: Physical Therapy

Interventions

  • OtherPhysical Therapy

    Physical therapy for chronic upper quarter myofascial pain syndrome, as prescribed by the patients' physicians

06

What researchers measure

Primary outcomes

  1. Change in Neck Disability Index

    Function neck scale with a total possible score of 50 indicating worse function compared to a score of 0.

    Time frame: 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.

    Time frame: Baseline to 3 months

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48108, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04929171
Lead sponsor
University of Michigan
Responsible party
David Kohns (Assistant Professor, University of Michigan) — Principal investigator
First posted
Jun 18, 2021
Start date
May 2, 2016
Primary completion
Nov 23, 2019
Completion
Nov 23, 2019
Last update
Sep 17, 2025

Study contacts

David J Kohnsd, DO
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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