A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Cleveland Clinic Florida
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Low Back Pain
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Low Back Pain
Time Frame: 6 months
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.