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

Primary Purpose

Back Pain, Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Mattress Cover

Placebo Mattress Cover

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Back Pain, Sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UC Irvine-MDA ALS and Neuromuscular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Mattress Cover

Placebo Mattress Cover

Arm Description

Subjects in this arm will be given the placebo mattress cover followed active mattress cover .

Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover.

Outcomes

Primary Outcome Measures

Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).

The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention). The daily scores range from 1 (very much improved) to 7 (very much worse).

Secondary Outcome Measures

Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.

Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.

Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.

Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.

Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.

Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.

Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.

Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.

Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.

Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.

Full Information

NCT ID

NCT00969540

First Posted

August 31, 2009

Last Updated

December 2, 2014

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT00969540

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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 mattresses 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 (containing optically modified polyethylene terephthalate fiber mattress cover) is more useful in helping back pain and sleep quality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain, Insomnia

Keywords

Back Pain, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Mattress Cover

Arm Type

Active Comparator

Arm Description

Subjects in this arm will be given the placebo mattress cover followed active mattress cover .

Arm Title

Placebo Mattress Cover

Arm Type

Placebo Comparator

Arm Description

Subjects in this arm will be given the active mattress cover followed by the placebo mattress cover.

Intervention Type

Device

Intervention Name(s)

Active Mattress Cover

Intervention Description

Active Mattress Cover

Intervention Type

Device

Intervention Name(s)

Placebo Mattress Cover

Intervention Description

Placebo Mattress Cover

Primary Outcome Measure Information:

Title

Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).

Description

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.

Description

Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.

Time Frame