Myofascial Pain and Central Sensitization

September 10, 2025 updated by: David Kohns, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Physical therapy for chronic upper quarter myofascial pain syndrome, as prescribed by the patients' physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PEG Score
Time Frame: Baseline to 3 months
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.
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: David J Kohnsd, DO, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Actual)

November 23, 2019

Study Completion (Actual)

November 23, 2019

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00093722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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