Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Insomnia Sleep Studies |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | June 2009 |
| End Date: | June 2011 |
| Contact: | Annabel K Wang, MD |
| Email: | akwang@uci.edu |
| Phone: | 714-456-2332 |
Double Blind, Placebo Controlled, Crossover Pilot Trial on the Effect of Optically Modified Polyethylene Terephthalate Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain
This is a research study because it is commonly observed that sleep in its quantity and
quality is influenced by the type of mattress used at night. A recent study in patients with
back pain showed that Waterbeds and Foam mattress did influence back symptoms, function and
sleep more positively than did a hard mattress. Pain improves with airbeds compared to
regular innerspring mattresses. This study will analyze the effect of optically active
particles mattress covers on sleep. The researcher is interested in learning if regular
mattress or the study mattress cover is more useful in helping back pain and sleep quality.
quality is influenced by the type of mattress used at night. A recent study in patients with
back pain showed that Waterbeds and Foam mattress did influence back symptoms, function and
sleep more positively than did a hard mattress. Pain improves with airbeds compared to
regular innerspring mattresses. This study will analyze the effect of optically active
particles mattress covers on sleep. The researcher is interested in learning if regular
mattress or the study mattress cover is more useful in helping back pain and sleep quality.
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 PM and 12 AM
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 PM 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
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