Study of the Insomnia in Patients With Low Back Pain

• Sleep - Mean subjective SOL, WASO, 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 ]
• 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 ]

• 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.

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.

• 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

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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 < 6.5 hours and/or usual SOL > 30 minutes for the last month prior to screening;
  • ISI > 14 (at least moderate insomnia);
  • Age 21-64 years;
  • Greater than 40 on VAS 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 NAP/LAN or ESZ;
  • 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 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.