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Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain

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ClinicalTrials.gov Identifier: NCT01044121
Recruitment Status : Terminated
First Posted : January 7, 2010
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Sleep To Live Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Sleep Disruption Other: Mattress Firmness Not Applicable

Detailed Description:

Few treatments are effective for chronic low-back pain, a disorder that causes marked social costs in developed countries. A "comfortable" mattress is commonly assumed to play an essential role, both on a preventive and on a therapeutic basis on chronic low-back pain. However, evidence supporting the beneficial effects of different levels of mattress support on pain is lacking.

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 effects on LBP 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 and
  2. whether the optimal mattress for reducing pain varies in the observed population.

The secondary objectives are:

  1. to determine whether there is a relationship between mattress firmness and sleep in this population;
  2. to determine whether there is a relationship between pain and sleep in this population;
  3. to determine whether key sleep variables (subjective or objective) are mediating or moderating factors of the relationship between mattress and level of low-back pain (LBP) and disability;
  4. to determine if different sleep surfaces have differential effects on measures of daily function among patients with chronic LBP;
  5. to evaluate if Kingsdown's proprietary algorithm for selecting optimal mattress "fits" with the subject's best mattress for reducing pain and improving sleep and measures of daytime functioning;
  6. to conduct exploratory regression analyses using variables included in the proprietary algorithm and other demographics and measures of physical characteristics to predict the optimal "fit" mattress (i.e., the mattress associated with lowest morning pain ratings, best sleep measures and optimal levels of daytime function);
  7. to determine if different sleep surfaces have differential effects on measures of partner sleep disturbance;
  8. to determine if there is a relationship between partner pain level and partner sleep disturbances.

Please see "Eligibility Criteria" for inclusion and exclusion information.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Latin-Square Crossover Study of the Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
Study Start Date : January 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mattress Firmness Other: Mattress Firmness
Current mattress and 6 experimental firmnesses of mattress as defined by a Comfort Support Analysis device.
Other Names:
  • Kingsdown
  • Sleep to Live


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of Pain [ Time Frame: Daily and every 3 weeks ]

Secondary Outcome Measures :
  1. Improved Sleep Quality [ Time Frame: Daily ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044121


Sponsors and Collaborators
Sleep To Live Institute
Duke University
Investigators
Principal Investigator: Robert Oexman, DC Sleep To Live Institute
More Information
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Responsible Party: Sleep To Live Institute
ClinicalTrials.gov Identifier: NCT01044121     History of Changes
Other Study ID Numbers: Duke-Pain-1113291
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Sleep To Live Institute:
mattress
pain
sleep
low back pain
back
neck
arousal
pillow
kingsdown
 sleep to live
duke university
sleep to live institute
missouri
springfield
joplin
body diagnostic
dormo diagnostic
morning pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms