Clinical Research Directory

Inclusion Criteria: You are eligible to participate in this study if you: 1. have a clinical diagnosis of chronic lower back pain 2. have pain measured on the Visual Analogue scale 3. have sleep disturbances at night associated with chronic lower back pain 4. are 18 years or older 5. sign the written, informed consent form prior to the initiation of any study procedures 6. have an habitual bedtime between 8 P.M. and 12 A.M. 7. are on a stable pain management regime Exclusion Criteria: You are not eligible to participate in this study if you: 1. are unwilling or unable to comply with the protocol or scheduled appointments 2. are unable to understand the language in which the approved informed consent is written 3. have no pain measured on the Visual Analogue scale 4. are unable to walk, wheel chair bound or confined to bed 5. are deemed by the investigator to be unreliable to wear the actigraphy, to complete the sleep log, to use the provided mattress covers at the proper time, to come to the scheduled visits or to answer questions regarding the subject's condition or medication use 6. lack a mobile arm to which to attach an actigraphy. 7. are currently participate or participated in another clinical study within the past 30 days 8. demonstrate an unwillingness to comply with the maximum limit of two alcoholic drinks per day and only 1 alcoholic drink after 6:00 P.M. for the duration of the protocol 9. use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle 10. have any unstable medical condition as determined by the investigator, or any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol