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 2, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Primary Insomnia
Drug: Eszopiclone
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 58
Study Start Date: August 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo nightly over duration of double blind study phase
Active Comparator: 2
Eszopiclone
Drug: Eszopiclone
Eszopiclone 3 mg po nightly for duration of study blind phase.
Other Name: Lunesta

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.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365976

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Sunovion
Investigators
Principal Investigator: Andrew D Krystal, MD Duke University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00365976     History of Changes
Other Study ID Numbers: Pro00011697, ESRC 032
Study First Received: August 16, 2006
Results First Received: March 19, 2013
Last Updated: July 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Insomnia
Low Back Pain
Hypnotics
Eszopiclone
Pain
Disability

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Eszopiclone
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015