Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
TerminatedNot applicableNCT01044121
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Latin-Square Crossover Study of the Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
- Conditions
- Low Back Pain
- Sleep Disruption
- Interventions
- Other: Mattress Firmness
- Sponsor
- Sleep To Live Institute
- Collaborators
- Duke University
- Start date
- 2010-01
- Primary completion
- 2012-07
- Sex
- All
- Age range
- from 21 Years to 64 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Vertebral Fractures * Rheumatoid Arthritis * Inability to comply * Untreated sleep disorders * Night-shift worker * Frequent travel * Parent of child under 2 * Pending litigation for pain issue * Corticosteroid use in the last 90 days
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01044121