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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04929171
Other study ID # HUM00093722
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2016
Est. completion date November 23, 2019

Study information

Verified date June 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 amplification.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 23, 2019
Est. primary completion date November 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Baseline to 3 months
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