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

January 8, 2013 updated by: Sleep To Live Institute

A Latin-Square Crossover Study of the Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of Pain
Time Frame: Daily and every 3 weeks
Daily and every 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved Sleep Quality
Time Frame: Daily
Daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sleep To Live Institute

Collaborators

Duke University

Investigators

  • Principal Investigator: Robert Oexman, DC, Sleep To Live Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Duke-Pain-1113291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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