Social & Behavioral Rhythms in Chronic Pain

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

Behavioral and biological rhythms are essential for health. No study evaluated behavioral rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective of this study is to gather preliminary data, focusing on the role of behavioral rhythms in the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood). Additionally, this study will provide preliminary data for the feasibility and acceptability of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic pain.

Key facts

Study ID

NCT03022643

Run by

University of Utah

People needed

62

Starts

2016-11-01

Expected to finish

2017-06-01

Last updated by the study team

2019-03-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All participants (patients and controls):
• 18-65 years of age with
• reading/writing proficiency in English.
• Aim 1:
• Patients must:
• have had persistent pain for more than 1-year at a consistent body part or diffuse body pain (e.g., fibromyalgia) that is stable rather than progressive in nature
• report experiencing pain for more than 70% of the waking hours in any given week
• under current medical care by a physician for a pain diagnosis
• able remain stable on any of their medication (as prescribed) for the duration of the 8-day evaluation involved in Aim 1
• Control subjects must:
• be pain-free for the past 1-year
• no prior treatment for a chronic pain condition
• in overall good health
• Aim 2:
• Patients must:
• have current symptoms of insomnia (Insomnia Severity Index (ISI), ISI>8)
• have depression (Patient Health Questionnaire-9, PHQ-9>10)
• exhibit significant circadian activity rhythm dysregulation during the 8-day evaluation (defined as Amplitude<0.9)
• Control subjects must:
• be pain-free for the past 1-year
• no prior treatment for a chronic pain condition
• in overall good health

You may not qualify if…

• Aim 1:
• patients/controls who underwent surgery in the last 6-months
• shift workers
• dementia
• current drug abuse/dependence
• receiving treatment in methadone clinic
• current cardiac conditions
• untreated sleep apnea
• untreated restless legs syndrome
• neurodegenerative disease
• bipolar disorder
• psychosis
• suicidal ideation
• have changed time-zones in the last 7 days
• experienced a significant life change in the last month (e.g., death in the family, loss of job, traumatic event)
• Aim 2:
• patients/controls who underwent surgery in the last 6-months
• shift workers
• dementia
• current drug abuse/dependence
• receiving treatment in methadone clinic
• current cardiac conditions
• untreated sleep apnea
• untreated restless legs syndrome
• neurodegenerative disease

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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