Low Back PainNCT01044121
Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
A study testing Mattress Firmness in people with Low Back Pain and Sleep Disruption, run by Sleep To Live Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Low Back Pain, Sleep Disruption
- What is being tested?
- Mattress Firmness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
About this study
Official title: 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:
- Whether there is a single mattress that is superior to the others in terms of reducing low-back pain and pain related disability.
- Whether the optimal mattress for reducing pain varies in the observed population.
Read the 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:
- whether there is a single mattress that is superior to the others in terms of reducing low-back pain and pain-related disability and
- whether the optimal mattress for reducing pain varies in the observed population.
The secondary objectives are:
- to determine whether there is a relationship between mattress firmness and sleep in this population;
- to determine whether there is a relationship between pain and sleep in this population;
- 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;
- to determine if different sleep surfaces have differential effects on measures of daily function among patients with chronic LBP;
- 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;
- 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);
- to determine if different sleep surfaces have differential effects on measures of partner sleep disturbance;
- to determine if there is a relationship between partner pain level and partner sleep disturbances.
Please see "Eligibility Criteria" for inclusion and exclusion information.
- Conditions
- Low Back Pain, Sleep Disruption
- Being tested
- Mattress Firmness
- Keywords
- 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
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mattress FirmnessOther
Also called Kingsdown, Sleep to Live
Current mattress and 6 experimental firmnesses of mattress as defined by a Comfort Support Analysis device.
| Study group | Role | What they receive |
|---|---|---|
| Mattress Firmness | Experimental | Not described Receives: Other: Mattress Firmness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Pain
Measured: Daily and every 3 weeks
Secondary outcomes (1)
Improved Sleep Quality
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sleep To Live Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Robert Oexman, DC, Principal investigator, Sleep To Live Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044121
- Sponsor's protocol ID
- Duke-Pain-1113291
- Status last verified
- Jan 2013
- First submitted
- 5 Jan 2010
- Last updated
- 10 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Latin-Square Crossover Study of the Effects of Mattress Firmness on Pain in Patients With Chronic Low-Back Pain
- ClinicalTrials.gov ID
- NCT01044121
- Acronym / sponsor ID
- Duke-Pain-1113291
- Conditions
- Low Back Pain, Sleep Disruption
- Keywords
- mattress, pain, sleep, low back pain, back, neck, arousal, pillow
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sleep To Live InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether there is a single mattress that is superior to the others in terms of reducing low-back pain and pain related disability.
- 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:
- whether there is a single mattress that is superior to the others in terms of reducing low-back pain and pain-related disability and
- whether the optimal mattress for reducing pain varies in the observed population.
The secondary objectives are:
- to determine whether there is a relationship between mattress firmness and sleep in this population;
- to determine whether there is a relationship between pain and sleep in this population;
- 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;
- to determine if different sleep surfaces have differential effects on measures of daily function among patients with chronic LBP;
- 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;
- 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);
- to determine if different sleep surfaces have differential effects on measures of partner sleep disturbance;
- 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
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mattress Firmness | Experimental | Other: Mattress Firmness |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- Neurologic or medical illness that is directly responsible for back pain
- Psychiatric disease
- Back related surgery
- Substance abuse
- Pregnancy (self or partner)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mattress FirmnessAlso: Kingsdown, Sleep to LiveCurrent mattress and 6 experimental firmnesses of mattress as defined by a Comfort Support Analysis device. | Other | Mattress Firmness |
Primary outcome
Reduction of Pain
Time frame: Daily and every 3 weeks
1 secondary outcome
Improved Sleep Quality
Time frame: Daily
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Oexman, DC principal investigator
Sleep To Live Institute
Questions about this trial
What is this clinical trial studying?
A study testing Mattress Firmness in people with Low Back Pain and Sleep Disruption, run by Sleep To Live Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Pain (time frame: Daily and every 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.