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

Study 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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Device: Back supports


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients in this group will receive physical therapy and posture education for low back pain | |
| Active Comparator: Test Group<br>Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain | Device: Back supports<br>* 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.<br>* Other names: Moller Back Support System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Low Back Pain | 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. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
backache, low backpain, sciatica