Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis

Not Applicable

Completed

• Conditions: Insomnia; Osteoarthritis of the Knee; Knee Pain
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT01683799
• Lead Sponsor: University of Rochester

Brief Summary

The purpose if the study is to determine whether improving sleep, especially slow wave or "deep" sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity and inflammatory responses to pain, and improves OA-related pain.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-12
• Study Start: 2013-02
• Primary Completion: 2015-07
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 50-75 years of age (for women, post-menopausal)
• Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees
• knee pain on most days for ≥ 6 months
• self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling, ascending or descending stairs, or performing daily activities
• willing and able to avoid all prescription and non-prescription, non-opiate pain medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks prior to testing
• meets research diagnostic criteria for sleep maintenance insomnia

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Exclusion Criteria

• health conditions with immunological components or undergoing or taking immunosuppressive therapies
• conditions contraindicated for or potentially limiting ability to conduct NFR and/or cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory conditions; leg/hip nerve damage; BMI ≥ 32)
• sleep disorders other than insomnia
• dementia or cognitive impairment
• history of schizophrenia or bipolar I disorder; current or recent history (within 3 months) of major psychiatric disorders
• current depressive symptomatology or current suicidality
• active substance dependence
• untreated hypertension
• use of antidepressants (stable use for 3 months okay), antipsychotics, mood stabilizers, sedative-hypnotics, opiate analgesics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insomnia treatment	Cognitive Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy for Insomnia

Primary Outcome Measures

Name	Time	Method
Change from baseline in nociception flexion reflex threshold	baseline and 10 weeks
Change from baseline in electrocutaneous pain threshold	baseline and 10 weeks
Change from baseline in minutes of time in slow wave sleep	baseline and 10 weeks
Change from baseline in relative power of delta EEG activity to index slow wave sleep activity	baseline and 10 weeks
Change from baseline in inflammatory cytokine responses to pain	baseline and 10 weeks
Change from baseline in Western Ontario and McMaster University OA Index	baseline and 10 weeks
Change from baseline in Knee Pain Scale score	baseline and 10 weeks

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States