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| Sponsor: | Sleep To Live Institute |
|---|---|
| Collaborator: |
Duke University |
| Information provided by: | Sleep To Live Institute |
| ClinicalTrials.gov Identifier: | NCT01044121 |
Purpose
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:
| Condition | Intervention |
|---|---|
|
Low Back Pain Sleep Disruption |
Other: Mattress Firmness |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Mattress Firmness |
Other: Mattress Firmness
Current mattress and 6 experimental firmnesses of mattress as defined by a Comfort Support Analysis device.
Other Names:
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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:
The secondary objectives are:
Please see "Eligibility Criteria" for inclusion and exclusion information.
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jason Ensor, BS, R. PSG/EEG T., CNIM | 417-619-4086 | jensor@sleeptolive.com |
| Contact: Robert Oexman, DC | 417-624-4422 | roexman@sleeptolive.com |
| United States, Missouri | |
| Sleep to Live Institute | Recruiting |
| Joplin, Missouri, United States, 64804 | |
| Contact: Jason Ensor, BS, R.PSG/EEG T., CNIM 417-619-4086 jensor@sleeptolive.com | |
| Contact: Robert Oexman, DC 417-624-4422 roexman@sleeptolive.com | |
| Principal Investigator: Robert Oexman, DC | |
| Sleep to Live Institute | Recruiting |
| Springfield, Missouri, United States, 65810 | |
| Contact: Jason Ensor, BS, R. PSG/EEG T., CNIM 417-619-4086 jensor@sleeptolive.com | |
| Contact: Robert Oexman, DC 417-624-4422 roexman@sleeptolive.com | |
| Principal Investigator: Robert Oexman, DC | |
| Principal Investigator: | Robert Oexman, DC | Sleep To Live Institute |
More Information
| Responsible Party: | Dr. Robert Oexman, Sleep to live Institute |
| ClinicalTrials.gov Identifier: | NCT01044121 History of Changes |
| Other Study ID Numbers: | Duke-Pain-1113291 |
| Study First Received: | January 5, 2010 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Back Pain Low Back Pain Pain |
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