Study of the Insomnia in Patients With Low Back Pain
|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) [ Time Frame: Postnaprosyn baseline, Week 1, week 2, week 4 ] [ Designated as safety issue: No ]Nightly total sleep time was averaged from diary entries.
- Visual Analog Scale Pain Ratings (VAS) [ Time Frame: Postnaprosyn baseline, Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]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
- Mean Sleep Onset Latency (SOL) [ Time Frame: Postnaprosyn Baseline, Week 1, Week 2 week 4 ] [ Designated as safety issue: No ]
- Wake Time After Sleep Onset [ Time Frame: Postnaprosyn Baseline, Week 1, Week 2 week 4 ] [ Designated as safety issue: No ]
- Number of Awakenings [ Time Frame: Postnaprosyn Baseline, Week 1, Week 2 week 4 ] [ Designated as safety issue: No ]
- Sleep Quality Ratings [ Time Frame: Postnaprosyn Baseline, Week 1, Week 2 week 4 ] [ Designated as safety issue: No ]Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep
- Insomnia Severity Index (ISI) [ Time Frame: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4 ] [ Designated as safety issue: No ]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).
- Patient Global Impression of Pain Ratings [ Time Frame: postnaprosyn Baseline, Week 1, Week 2 week 4 ] [ Designated as safety issue: No ]Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)
- Roland Morris Low Back Pain Inventory (RMLBPI) [ Time Frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4 ] [ Designated as safety issue: No ]
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).
- Hamilton Depression Rating Scale (HAM-D-24) [ Time Frame: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4 ] [ Designated as safety issue: No ]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.
- Short Form 36 Health Survey Questionnaire (SF-36) [ Time Frame: Baseline, week 1, week 2, week 4 ] [ Designated as safety issue: No ]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).
- State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, week 1, week 2, week 4 ] [ Designated as safety issue: No ]Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365976
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew D Krystal, MD||Duke University|