NCT00365976

Study of the Insomnia in Patients With Low Back Pain

Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.

Detailed description

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.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3 mg po nightly for duration of study blind phase.
DRUG	Placebo	Placebo nightly over duration of double blind study phase

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2006-08-18
• Last updated: 2015-07-24
• Results posted: 2013-06-07

Locations

1 site across 1 country: United States