Clinical trial NCT00553540: Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Official title: A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: backache
low backpain
sciatica
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Integral Orthopedics Inc.
First posted: 2007-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Low Back Pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Vinod K Podichetty, MD,MS
role: STUDY_DIRECTOR
affiliation: Cleveland Clinic Florida
name: David Westerdahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
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citation: 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.