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

NeuroTherapia, Inc.

Status

Completed

Conditions

Low Back Pain

Treatments

Device: Back supports

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00553540

IOI

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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