Study of the Insomnia in Patients With Low Back Pain
The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain|
- Mean Subjective Sleep Diary Derived Total Sleep Time (TST) Averaged Over the Entire Month of the Double Blind Phase. [ Time Frame: Average of nightly values over the month-long double blind phase ] [ Designated as safety issue: No ]
- Sleep - Mean Subjective SOL, WASO (Wake After Sleep Onset), Sleep Quality and Awakenings, and ISI Over the Month of Double-blind Treatment [ Time Frame: Averaged over the month of double-blind treatment ] [ Designated as safety issue: No ]
- Pain - Mean Change From Baseline in VAS and PGI Pain Ratings Over the Month of Double Blind Treatment. [ Time Frame: Averaged over the month of double-blind treatment ] [ Designated as safety issue: No ]PGI (Patient Global Impression)
- Function - Mean Change From Baseline in: RMLBPDQ, HAM-D24 Rating, ISI Function Items, STAI Ratings Averaged for Weeks 1,2, and 4 of Double Blind Treatment. Change From Baseline in Each of the SF-36 Subscales. [ Time Frame: Averaged for weeks 1,2, and 4 of double blind treatment ] [ Designated as safety issue: No ]RMLBPDQ (Rolande-Morris Low Back Pain Disability Questionnaire) HAM-D24 (Hamilton Depression Rating Scale, 24 item) SF-36 (Short Form Health Survey) STAI (State-Trait Anxiety Inventory)
|Study Start Date:||August 2006|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Placebo nightly over duration of double blind study phase
Active Comparator: 2
Eszopiclone 3 mg po nightly for duration of study blind phase.
Other Name: Lunesta
There is a great need to develop effective treatments for insomnia in patients with chronic low-back pain. Chronic low-back pain is among the most prevalent of all health complaints, is associated with enormous health-care and productivity costs, reduced quality of life, and limitation of function and is almost universally associated with insomnia (Rives and Douglas, 2004). While it had long been believed that insomnia was a symptom of pain conditions and of little consequence in its' own right, a growing literature suggests that insomnia has important effects on the clinical course of pain syndromes (Smith and Haythornthwaite, 2004). While pain may disrupt sleep, it appears that problems with sleep increase pain and are associated with impairments in daytime function. The emerging point of view is that specific treatment for both pain and insomnia is needed for optimal clinical management (Smith and Haythornthwaite, 2004). Surprisingly, despite the fact that chronic low-back pain is the most common pain condition, the treatment of insomnia in this disease has never been studied. As a result, we propose to carry out the first double-blind placebo-controlled study of the treatment insomnia in patients with chronic low back pain.
Comparison(s): We will test the hypothesis that treating the insomnia with eszopiclone 3 mg (ESZ) along with management of pain with naproxen 500 mg bid (NAP) will result in statistically significantly improved sleep compared with placebo. We also propose to test as a secondary hypothesis that treatment with ESZ will lead to significant improvement in pain and daytime function vs. placebo.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew D Krystal, MD||Duke University|