N/A N=8 Randomized Triple-blind Treatment

Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain

Back Pain · Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT00969540 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). — 4.07; 3.86; 3.93; 3.86 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active Mattress Cover (Device); Placebo Mattress Cover (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).	4.07; 3.86; 3.93; 3.86; 3.86; 3.86	—
SECONDARY Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.	53.38; 71.31; 59.15; 107.38; 113.83; 128.38	—
SECONDARY Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.	433.15; 435.92; 406.54; 384.00; 447.83; 435.46	—
SECONDARY Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.	19.85; 23.46; 10.62; 12.31; 19.08; 22.23	—
SECONDARY Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.	88.17; 85.65; 87.28; 76.72; 79.35; 75.95	—
SECONDARY Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.	2.92; 1.46; 1.15; 0; 9.75; 7.54	—

Summary

Sleep quantity and quality can be influenced by the type of mattress used. This study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep quality.

Eligibility Criteria

Inclusion Criteria

You are eligible to participate in this study if you:

have a clinical diagnosis of chronic lower back pain
have pain measured on the Visual Analogue scale
have sleep disturbances at night associated with chronic lower back pain
are 18 years or older
sign the written, informed consent form prior to the initiation of any study procedures
have an habitual bedtime between 8 P.M. and 12 A.M.
are on a stable pain management regime

Exclusion Criteria

You are not eligible to participate in this study if you:

are unwilling or unable to comply with the protocol or scheduled appointments
are unable to understand the language in which the approved informed consent is written
have no pain measured on the Visual Analogue scale
are unable to walk, wheel chair bound or confined to bed
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
lack a mobile arm to which to attach an actigraphy.
are currently participate or participated in another clinical study within the past 30 days
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
use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00969540). 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.