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Study of Mattress Type in Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01108718
First received: March 23, 2010
Last updated: January 11, 2012
Last verified: January 2012
History of Changes
  Purpose

Patients with Fibromyalgia using a brand mattress will show greater improvement sleeping than when using a comparison mattress.


Condition Intervention Phase
Fibromyalgia
 Device: Brand name mattress
Device: Comparison mattress
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Mattress Type in Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Sleep indices as determined by polysomnography and improvement in a number of tender points. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    The study is 6 months in duration and is anticipated to be completed within 15 months. Study participants are being reimbursed for their time.


Estimated Enrollment: 12
Study Start Date: July 2009
Study Completion Date: January 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with Fibromyalgia
Half of the patients with Fibromyalgia will receive the brand mattress followed by the control mattress while half will get the control followed by the Brand mattress.
 Device: Brand name mattress
Used for a two month duration
Device: Comparison mattress
Used for two month duration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108718

Locations
United States, New York
Pain and Fatigue Study Center - Beth Israel Medical Center
New York, New York, United States, 10014
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Benjamin Natelson, MD Beth Israel Medical Center
  More Information

Additional Information:
The Pain and Fatigue Study Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01108718     History of Changes
Other Study ID Numbers: BIMC 015-09
Study First Received: March 23, 2010
Last Updated: January 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
Mattress

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013