NCT04929171

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3.6 years

First QC Date

June 10, 2021

Last Update Submit

September 10, 2025

Conditions

Outcome Measures

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.

    Baseline to 3 months

Secondary Outcomes (1)

  • Change in PEG Score

    Baseline to 3 months

Study Arms (1)

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

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

Patients with myofascial pain having centralized pain features

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • David J Kohnsd, DO

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

May 2, 2016

Primary Completion

November 23, 2019

Study Completion

November 23, 2019

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations