The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo nightly over duration of double blind study phase
Duke University Medical Center
Durham, North Carolina, United States
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
Nightly total sleep time was averaged from diary entries.
Time frame: Postnaprosyn baseline, Week 1, week 2, week 4
Visual Analog Scale Pain Ratings (VAS)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Time frame: Postnaprosyn baseline, Week 1, Week 2, Week 4
Mean Sleep Onset Latency (SOL)
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Wake Time After Sleep Onset
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Number of Awakenings
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Sleep Quality Ratings
Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep
Time frame: Postnaprosyn Baseline, Week 1, Week 2 week 4
Insomnia Severity Index (ISI)
The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia).
Time frame: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4
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Patient Global Impression of Pain Ratings
Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)
Time frame: postnaprosyn Baseline, Week 1, Week 2 week 4
Roland Morris Low Back Pain Inventory (RMLBPI)
The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 "yes-no" items assessing potential disabilities. Scores range from 0 (no disability) to 24 (severe disability).
Time frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Hamilton Depression Rating Scale (HAM-D-24)
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Time frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Short Form 36 Health Survey Questionnaire (SF-36)
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Time frame: Baseline, week 1, week 2, week 4
State-Trait Anxiety Inventory (STAI)
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)
Time frame: Baseline, week 1, week 2, week 4