Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

Sponsors

Lead Sponsor: Cleveland Clinic Florida

Collaborator: Integral Orthopedics Inc.

Source The Cleveland Clinic
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.

Overall Status Completed
Start Date 2006-10-01
Completion Date 2008-08-01
Primary Completion Date 2008-08-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Low Back Pain 6 months
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: Back supports

Description: 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.

Arm Group Label: Test Group

Other Name: Moller Back Support System

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Location
Facility: Cleveland Clinic Florida
Location Countries

United States

Verification Date

2019-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control Group

Type: No Intervention

Description: Patients in this group will receive physical therapy and posture education for low back pain

Label: Test Group

Type: Active Comparator

Description: Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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