- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00553540
Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
November 5, 2019 updated by: Cleveland Clinic Florida
A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.
Study Overview
Detailed Description
Back pain is a common and expensive medical condition.
Although rarely life-threatening, back disorders are a major cause of pain, disability, and social cost affecting the quality of life in most patients.
Although primary care providers routinely treat back pain, little is known about how often primary care providers manage occupation-related symptoms and how outcomes compare with other treatment modalities.
Treatment outcomes utilizing a non-operative treatment paradigm have not been adequately studied.
This paradigm consists of treating patients sequentially with analgesics, physical therapy, use of back supports, caudal epidural steroid injections, or surgical referral.
The use of spinal supports as a complimentary treatment along with physical therapy and posture education is promising.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Weston, Florida, United States, 33331
- Cleveland Clinic Florida
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must present with clinical symptoms of low back pain and evaluated by the study physician
- Visual Analog Score (VAS) for Pain >6 in response to the following question: Circle one number (from 0 = no pain to 10 = worst pain) "How would you rate the worst pain you experienced in last week."
- Patients must have x-ray and or an MRI film for diagnostic evaluation based on physician judgment.
- Age >18; both male and female
- Pain duration >3 months
Exclusion Criteria:
- Prior use of opioids, physical therapy, epidural injections for back pain or ongoing chiropractor care and or acupuncture treatment
- Moderate to severe arthritis of the spine/ knee or hip that might severely compromise ambulation and or posture
- Patients with diagnosed lumbar canal stenosis
- Serious concomitant medical illness (i.e., heart disease)
- Obese patients (twice the width of the Moller Orthopedic Back Support)
- Patients with moderate to severe scoliosis
- Past or present existence of a movement disorder, e.g., Parkinsonism, or any neurological disease that might affect ambulation and or postural changes History of osteoporosis
- Severe psychiatric disorder
- Prior spine surgery
- Multiple vertebral compression fractures with kyphosis
- Past or present workmen's compensation claim, SSI disability, or ongoing litigation
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Patients in this group will receive physical therapy and posture education for low back pain
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Active Comparator: Test Group
Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain
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The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support.
They are to be placed in the chair used in workstation related jobs.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Low Back Pain
Time Frame: 6 months
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numeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24.
Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Vinod K Podichetty, MD,MS, Cleveland Clinic Florida
- Principal Investigator: David Westerdahl, MD, Cleveland Clinic Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Andersson GBJ. The epidemiology of spinal disorders. In: Frymoyer JW, Ducker TB, Hadler NM, et al, eds. The Adult Spine: Principles and Practice. Philadelphia: Lippincott-Raven, 1997:93-141.
- Leboeuf-Yde C, Lauritsen JM. The prevalence of low back pain in the literature. A structured review of 26 Nordic studies from 1954 to 1993. Spine (Phila Pa 1976). 1995 Oct 1;20(19):2112-8. doi: 10.1097/00007632-199510000-00009.
- Frymoyer JW, Durett CL. The economics of spinal disorders. In: Frymoyer JW, Ducker TB, Hadler NM, et al, eds. The Adult Spine: Principles and Practice. Philadelphia: Lippincott-Raven, 1997:143-150.
- Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine (Phila Pa 1976). 1995 Jan 1;20(1):11-9. doi: 10.1097/00007632-199501000-00003.
- Coste J, Delecoeuillerie G, Cohen de Lara A, Le Parc JM, Paolaggi JB. Clinical course and prognostic factors in acute low back pain: an inception cohort study in primary care practice. BMJ. 1994 Feb 26;308(6928):577-80. doi: 10.1136/bmj.308.6928.577.
- Deyo RA, Phillips WR. Low back pain. A primary care challenge. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2826-32. doi: 10.1097/00007632-199612150-00003.
- Carey TS, Garrett JM, Jackman A, Hadler N. Recurrence and care seeking after acute back pain: results of a long-term follow-up study. North Carolina Back Pain Project. Med Care. 1999 Feb;37(2):157-64. doi: 10.1097/00005650-199902000-00006.
- Bernard BP. Introduction. In: Bernard BP, ed. Musculoskeletal Disorders and Workplace Factors. Cincinnati: National Institute for Occupational Safety and Health, Centers for Disease Control, U.S. Department of Health and Human Services, 1997.
- Murphy PL, Volinn E. Is occupational low back pain on the rise? Spine (Phila Pa 1976). 1999 Apr 1;24(7):691-7. doi: 10.1097/00007632-199904010-00015.
- van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine (Phila Pa 1976). 1997 Sep 15;22(18):2128-56. doi: 10.1097/00007632-199709150-00012.
- Podichetty VK, Varley ES. Spinal supports and physical therapy in patients with low back pain: a case series. BMJ Case Rep. 2009;2009:bcr07.2008.0405. doi: 10.1136/bcr.07.2008.0405. Epub 2009 Apr 23.
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
October 1, 2006
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
November 2, 2007
First Submitted That Met QC Criteria
November 2, 2007
First Posted (Estimate)
November 4, 2007
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 5, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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