N/A Completed N=21 Randomized Treatment

Treatment of Insomnia Secondary to Chronic Pain

Insomnia · Postoperative Pain

Source: ClinicalTrials.gov NCT00127790 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcomePrimary: Insomnia Severity — 6.0; 12.8; 4.4; 13.0 units on a scale — p=0.010

Summary

Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.

Outcome Measures

Outcome	Result	p-value
PRIMARY Insomnia Severity	6.0; 12.8; 4.4; 13.0	0.010 sig
PRIMARY Pain Severity	11.0; 6.2; 8.8; 7.5	0.33
PRIMARY IL-6	0.7; 1.6; 1.2; 1.2	0.063
SECONDARY Depression Severity	2.3; 10.2; 4.4; 17.6	0.016 sig

Eligibility Criteria

Inclusion Criteria

Ages 35-75
Chronic non-malignant painful condition of the spine of > 6 months duration
Insomnia (> 30 minutes sleep latency and/or wake after sleep onset time for > 3 days/week for > 6 months)
Insomnia developed after the onset of the painful condition
Preferred sleep phase between 10: 00 p.m. and 8:00 am
On stable medical regimen for medical and pain conditions (no surgery planned)
Willingness to discontinue hypnotic medications

Exclusion Criteria

Unstable medical or psychiatric illness
History of seizures
Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence
Symptoms suggestive of sleep disorders other than insomnia
Polysomnographic data indicating sleep disorders other than insomnia
Inadequate language comprehension
Fibromyalgia
Pregnancy

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Data sourced from ClinicalTrials.gov (NCT00127790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.