Study of the Insomnia in Patients With Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00365976
First received: August 16, 2006
Last updated: July 11, 2014
Last verified: March 2013

August 16, 2006
July 11, 2014
August 2006
September 2010   (final data collection date for primary outcome measure)
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 ]
Mean subjective sleep diary derived TST averaged over the entire month of the double blind phase.
Complete list of historical versions of study NCT00365976 on ClinicalTrials.gov Archive Site
  • 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)
  • Sleep – Mean subjective SOL, WASO, Sleep Quality and Awakenings, and ISI over the month of double-blind treatment
  • Pain – Mean change from baseline in VAS and PGI pain ratings over the month of double blind treatment.
  • 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.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Insomnia
  • Drug: Eszopiclone
    Eszopiclone 3 mg po nightly for duration of study blind phase.
    Other Name: Lunesta
  • Drug: Placebo
    Placebo nightly over duration of double blind study phase
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Eszopiclone
    Intervention: Drug: Eszopiclone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • • Diagnosis of insomnia based on DSM-IV criteria for insomnia due to a general medical condition (low-back pain);

    • The insomnia must not predate the onset of low-back pain by more than 1 month;
    • Usual nightly TST (Total Sleep Time) < 6.5 hours and/or usual SOL (Sleep Onset Latency) > 30 minutes for the last month prior to screening;
    • ISI (Insomnia Severity Index) > 14 (at least moderate insomnia);
    • Age 21-64 years;
    • Greater than 40 on VAS (Visual Analog Scale) for pain (scale is 0-no pain to 100-worst imaginable pain);
    • Patient Global Impression of Pain of at least 3 (on a 1-5 scale, indicating at least moderate severity);
    • reported Back pain must be greater than reported leg pain, and there must be no signs of spinal nerve root compression;
    • presence of normal motor strength on exam;
    • duration of chronic low back pain of greater than three months;
    • low back pain location must be inferior to T12 and superior to the gluteal fold.

Exclusion Criteria:

  • • Significant medical or neurological illness in excess of that which is directly responsible for the chronic low back pain;

    • the presence of an active and significant psychiatric disease with a substantive impact on sleep;
    • meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
    • current pregnancy; history of hypersensitivity, intolerance, or contraindication to Naproxen/Lansoprazole or Eszopiclone;
    • baseline creatinine of 2.0 or greater; patient taking other medications having significant renal effects (e.g. lithium, ACE inhibitor, angiotensin receptor antagonist, or thiazide/loop diuretics);
    • patients taking other anticoagulants; patients having an allergy to aspirin; history of diagnosed gastric or duodenal ulcer;
    • history of bleeding or clotting diathesis; lifetime history of myocardial infarction or cerebrovascular accident;
    • Elevated PT/PTT/INR (Prothrombin Time, Partial Thromboplastin Time, International Normalized Ratio)at screening;
    • Abnormal kidney function detected in screening labs;
    • history of back related surgery within the past 3 months; history of corticosteroid use in the past 30 days;
    • presence of currently pending litigation or worker's compensation claim related to the chronic low back pain;
    • inability to follow study procedures or complete the study; or the use of any medications that could affect sleep within 5 half-lives of screening;
    • history of back surgery within the past 2 years with the exception of a discectomy;
    • pregnant or lactating females;
    • women of child-bearing potential who will not agree to use approved means of birth control during the trial;
    • history of any surgery within the past one month; history of any major physical trauma within the last 6 months;
    • history of corticosteroid use within the last 90 days; diagnosis of rheumatoid or psoriatic arthritis;
    • history of fibromyalgia;
    • presence of spondyloarthropathy;
    • presence of sciatica;
    • spinal stenosis;
    • presence of any vertebral fractures, spondylolisthesis; or radicular back pain.
Both
21 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365976
Pro00011697, ESRC 032
No
Duke University
Duke University
Sunovion
Principal Investigator: Andrew D Krystal, MD Duke University
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP