Back Pain, Insomnia
Conditions
Keywords
Back Pain, Sleep
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.
Interventions
DEVICEActive Mattress Cover
Active Mattress Cover
DEVICEPlacebo Mattress Cover
Placebo Mattress Cover
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | 14 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Assessed daily for 14 days per intervention. | 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. | Assessed daily for 14 days per intervention. | 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. | Assessed daily for 14 days per intervention. | 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. | Assessed daily for 14 days per intervention. | 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. | Assessed daily for 14 days per intervention. | Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover. |
Countries
United States
Participant flow
Recruitment details
Recruitment was by advertisement.
Pre-assignment details
A total of 8 participants were entered into this crossover study. The total duration of the study was approximately 49 days, including 14 days of screening and 14 days of the first intervention, 7 days of washout, and 14 days of the second intervention.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Mattress Cover First, Then Active Mattress Cover Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days. | 3 |
| Active Mattress Cover First, Then Placebo Mattress Cover Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days. | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Active Mattress Cover First, Then Placebo Mattress Cover | Placebo Mattress Cover First, Then Active Mattress Cover | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 7 | 46 years STANDARD_DEVIATION 13 | 47 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
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).
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).
Time frame: 14 days
Population: The sponsor determined the size of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mean CGI Pain Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 6 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 1 | 4.07 units on a scale | Standard Deviation 1.27 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 2 | 3.86 units on a scale | Standard Deviation 0.53 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 3 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 5 | 3.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 4 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 5 | 3.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 6 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 2 | 3.86 units on a scale | Standard Deviation 0.66 |
| Mean CGI Pain Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 1 | 3.86 units on a scale | Standard Deviation 1.1 |
| Mean CGI Pain Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 3 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Pain Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 4 | 4.07 units on a scale | Standard Deviation 0.27 |
| Mean CGI Sleep Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 1 | 3.93 units on a scale | Standard Deviation 1.27 |
| Mean CGI Sleep Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 5 | 3.14 units on a scale | Standard Deviation 0.53 |
| Mean CGI Sleep Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 4 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Sleep Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 2 | 3.86 units on a scale | Standard Deviation 0.77 |
| Mean CGI Sleep Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 6 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Sleep Scores With Placebo Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 3 | 3.92 units on a scale | Standard Deviation 0.29 |
| Mean CGI Sleep Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 6 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Sleep Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 1 | 3.86 units on a scale | Standard Deviation 1.1 |
| Mean CGI Sleep Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 2 | 3.93 units on a scale | Standard Deviation 0.62 |
| Mean CGI Sleep Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 3 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Sleep Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 4 | 4.00 units on a scale | Standard Deviation 0 |
| Mean CGI Sleep Scores With Active Mattress Cover. | Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI). | Subject 5 | 3.00 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: Assessed daily for 14 days per intervention.
Population: The sponsor determined the number of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 53.38 Minutes | Standard Deviation 26.7 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 59.15 Minutes | Standard Deviation 19.72 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 113.83 Minutes | Standard Deviation 34.37 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 50.23 Minutes | Standard Deviation 35.3 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 44.91 Minutes | Standard Deviation 50.58 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 71.75 Minutes | Standard Deviation 25.11 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 49.92 Minutes | Standard Deviation 38.7 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 71.31 Minutes | Standard Deviation 28.42 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 76.09 Minutes | Standard Deviation 37.27 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 107.38 Minutes | Standard Deviation 50.76 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 80.58 Minutes | Standard Deviation 27.49 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 128.38 Minutes | Standard Deviation 77.08 |
Secondary
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.
Time frame: Assessed daily for 14 days per intervention.
Population: The sponsor determined the number of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 10.73 Awakenings | Standard Deviation 10.14 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 10.62 Awakenings | Standard Deviation 2.4 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 20.38 Awakenings | Standard Deviation 12.59 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 19.08 Awakenings | Standard Deviation 5.32 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 17.17 Awakenings | Standard Deviation 4.84 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 19.85 Awakenings | Standard Deviation 10.53 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 18.25 Awakenings | Standard Deviation 6.33 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 26.27 Awakenings | Standard Deviation 9.88 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 10.54 Awakenings | Standard Deviation 7.49 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 23.46 Awakenings | Standard Deviation 8.36 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 12.31 Awakenings | Standard Deviation 4.13 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 22.23 Awakenings | Standard Deviation 11.06 |
Secondary
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.
Time frame: Assessed daily for 14 days per intervention.
Population: The sponsor determined the number of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 88.17 Percentage of time asleep | Standard Deviation 5.51 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 87.28 Percentage of time asleep | Standard Deviation 2.76 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 79.35 Percentage of time asleep | Standard Deviation 9.3 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 88.37 Percentage of time asleep | Standard Deviation 7.64 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 90.85 Percentage of time asleep | Standard Deviation 10.28 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 83.79 Percentage of time asleep | Standard Deviation 2.53 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 89.58 Percentage of time asleep | Standard Deviation 8.28 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 85.65 Percentage of time asleep | Standard Deviation 5.62 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 84.00 Percentage of time asleep | Standard Deviation 7.68 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 76.72 Percentage of time asleep | Standard Deviation 14.18 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 79.67 Percentage of time asleep | Standard Deviation 6.02 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 75.95 Percentage of time asleep | Standard Deviation 14.84 |
Secondary
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.
Time frame: Assessed daily for 14 days per intervention.
Population: The sponsor determined the number of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 2.92 Minutes | Standard Deviation 5.06 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 1.15 Minutes | Standard Deviation 3.36 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 9.75 Minutes | Standard Deviation 18.86 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 2.69 Minutes | Standard Deviation 9.71 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 0.91 Minutes | Standard Deviation 2.43 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 4.83 Minutes | Standard Deviation 7.03 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 0.15 Minutes | Standard Deviation 0.55 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 1.46 Minutes | Standard Deviation 2.5 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | .27 Minutes | Standard Deviation 0.9 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 0 Minutes | Standard Deviation 0 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 5.17 Minutes | Standard Deviation 10.66 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 7.54 Minutes | Standard Deviation 18.33 |
Secondary
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.
Time frame: Assessed daily for 14 days per intervention.
Population: The sponsor determined the number of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 433.15 Minutes | Standard Deviation 110.8 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 406.54 Minutes | Standard Deviation 46.23 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 447.83 Minutes | Standard Deviation 190.13 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 401.54 Minutes | Standard Deviation 61.69 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 476.45 Minutes | Standard Deviation 87.86 |
| Mean CGI Pain Scores With Placebo Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 394.67 Minutes | Standard Deviation 94.64 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 5 | 451.85 Minutes | Standard Deviation 95.54 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 1 | 435.92 Minutes | Standard Deviation 75.93 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 4 | 400.73 Minutes | Standard Deviation 45.71 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 2 | 384.00 Minutes | Standard Deviation 113.18 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 6 | 341.75 Minutes | Standard Deviation 71.75 |
| Mean CGI Pain Scores With Active Mattress Cover. | Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain. | Subject 3 | 435.46 Minutes | Standard Deviation 103.15 |