Myofascial Pain and Central Sensitization

Physical Therapy Clinical Trial

Official title:

The Impact of Nociplastic Pain Features on the Response to Physical Therapy in Patients With Primary Myofascial Pain: A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929171
• Other study ID #: HUM00093722
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes
• Physical Therapy

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