Insomnia, Knee Pain, Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis, Insomnia, Chronic pain, Cognitive Behavioral Therapy for Insomnia, Inflammation, Inflammatory cytokines
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
6-week behavioral treatment for insomnia
Sponsors
National Institute on Aging (NIA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 nociception flexion reflex threshold | baseline and 10 weeks |
| Change from baseline in electrocutaneous pain threshold | 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 |
Countries
United States
Outcome results
None listed