Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
A Latin-Square Crossover Study of the Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The primary study objective is to determine whether mattress firmness affects pain in patients with chronic low-back pain. We hypothesize that mattresses that differ in their firmness and support should have a varying effect on low-back pain patients' level of pain and pain-related disability. We also seek to test the hypothesis that the optimal mattress might vary from person to person. In this regard, we will test:
- 1.Whether there is a single mattress that is superior to the others in terms of reducing low-back pain and pain related disability.
- 2.Whether the optimal mattress for reducing pain varies in the observed population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Jan 2010
Typical duration for not_applicable low-back-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJanuary 10, 2013
January 1, 2013
2.5 years
January 5, 2010
January 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of Pain
Daily and every 3 weeks
Secondary Outcomes (1)
Improved Sleep Quality
Daily
Study Arms (1)
Mattress Firmness
EXPERIMENTALInterventions
Current mattress and 6 experimental firmnesses of mattress as defined by a Comfort Support Analysis device.
Eligibility Criteria
You may qualify if:
- Low back pain location must be inferior to T12 and superior to the gluteal fold and chronic (greater than 3 months)
- Patient Global Impression for Pain of at least 3 on a 1-5 scale (moderate severity)
- Visual Analog Scale for Pain of at least 40 on a 100 point scale (0 = no pain; 100 = worst pain)
- Presence of normal motor strength on exam
- English speaking and reading man/woman between the ages of 21-64
You may not qualify if:
- Neurologic or medical illness that is directly responsible for back pain
- Psychiatric disease
- Back related surgery
- Substance abuse
- Pregnancy (self or partner)
- Sleep-affecting medications
- Recent surgery
- Recent physical trauma
- Fibromyalgia
- Spinal Stenosis
- Sciatica
- Spondylolisthesis
- Spondyloarthropathy
- Sciatica
- Spinal Stenosis
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sleep To Live Institutelead
- Duke Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Oexman, DC
Sleep To Live Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 7, 2010
Study Start
January 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
January 10, 2013
Record last verified: 2013-01