Sleep changes from exercise in chronic pain patients

Not Applicable

Completed

• Conditions: Chronic temporomandibular pain disorder; Nervous System Diseases

• Registration Number: ISRCTN16093248
• Lead Sponsor: ational Institute of Nursing Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-15
• Study Start: 2023-08-07
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged 18 - 65 years
2. Can speak and write in English
3. Myogenous chronic non-neuropathic pain equal to at least 2 on a scale of 1-10 for orofacial pain
4. Pain duration longer than 3 months
5. Type of pain is in the jaw, temple, in ear, or in front of the ears
6. Pain is modified with jaw movement, function, or parafunction
7. Exam positive for confirmation of pain location(s) in the temporalis or masseter muscle(s) and reports familiar pain in the temporalis or masseter muscle(s) with at least one of the following provocation tests: Palpation of the temporalis or masseter muscle(s) or maximum unassisted or assisted opening movement(s).

Exclusion Criteria

1. Aged over 65 years
2. History of local or general trauma, degenerative neuromuscular diseases, cervical pain (ie. stenosis, radiculopathy)
3. Removable full dental prostheses
4. Neuropathic temporomandibular pain
5. Major neurological or psychiatric disorders (ie. schizophrenia, bipolar disorders, autism).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Sleep quality is measured using Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbances, and an actigraph watch continuously for the 4 weeks of the study. PROMIS-sleep disturbance is measured at baseline, week 1 to week 4. Actigraphy is obtained continuously over the 4 weeks. <br>2. Chronic pain related outcomes including chronic pain interference, pain behavior, depression and anxiety were assessed weekly using PROMIS pain interference, pain behavior, depression and anxiety scales. Pain related outcomes are measured at baseline, week 1 to week 4.

Secondary Outcome Measures

Name	Time	Method
Peripheral blood mononuclear cells RNA changes. Peripheral blood is withdrawn at the baseline enrollment visit and at the end of the intervention period for both exercise and no exercise groups.