Fibromyalgia
Conditions
Keywords
Mattress, Tempur-Pedic, Fibromyalgia, Sleep patterns
Brief summary
The purpose of this research study is to determine if a new mattress relieves the symptoms of fibromyalgia and improves sleep, and if this is the case, whether one type of mattress is better than the other in doing so.
Detailed description
The various stages of sleep will be monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Changes in the severity of fibromyalgia symptoms will be assessed by tender point exam and study questionnaires administered at 2 month intervals.
Interventions
OTHERTempur-Pedic Mattress (2 months)
Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
OTHERControl Mattress (2 months)
Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic Mattress.
Sponsors
Beth Israel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia -- that is they have both wide spread pain and more than 10 of the 18 tender points * 18 years of age or older * Has to be on stable medications and followed by one physician
Exclusion criteria
* Subjects with the existence of an undiagnosed sleep disorder - namely obstructive sleep apnea or periodic leg movement syndrome * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mattress Preference of Fibromyalgia Patients | 6 months | Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test. |
Countries
United States
Participant flow
Recruitment details
Patients from Principal Investigator's clinical practice at Beth Israel Medical Center in New York who fulfilled the 1990 case definition for fibromyalgia.
Pre-assignment details
Subjects who displayed the existence of a previously undiagnosed sleep disorder were excluded from study participation.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Who Receive Tempur-Pedic Mattress First(2 Months) Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first. | 5 |
| Subjects Who Receive the Control Mattress First(2 Months) Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first. | 7 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Received Second Intervention (2 Months) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Subjects Who Receive Tempur-Pedic Mattress First(2 Months) | Subjects Who Receive the Control Mattress First(2 Months) | 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 | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 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 | 1 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 |
Outcome results
Primary
Mattress Preference of Fibromyalgia Patients
Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.
Time frame: 6 months
Population: Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Mattress Preference of Fibromyalgia Patients | Tempur-Pedic Mattress | 45 percentage of study participants |
| All Participants | Mattress Preference of Fibromyalgia Patients | Control Mattress | 55 percentage of study participants |
| All Participants | Mattress Preference of Fibromyalgia Patients | No Preference | 0 percentage of study participants |
Comparison: h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattressp-value: >0.195% CI: [0.43, 0.47]McNemar