We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 5, 2010
First Posted Date  ICMJE January 7, 2010
Last Update Posted Date January 10, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2010)
Reduction of Pain [ Time Frame: Daily and every 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2010)
Improved Sleep Quality [ Time Frame: Daily ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
Official Title  ICMJE A Latin-Square Crossover Study of the Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Low Back Pain
  • Sleep Disruption
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Mattress Firmness
Intervention: Other: Mattress Firmness
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 6, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01044121
Other Study ID Numbers  ICMJE Duke-Pain-1113291
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sleep To Live Institute
Original Responsible Party Dr. Robert Oexman, Sleep to live Institute
Current Study Sponsor  ICMJE Sleep To Live Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Duke University
Investigators  ICMJE
Principal Investigator: Robert Oexman, DC Sleep To Live Institute
PRS Account Sleep To Live Institute
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP