Official Title: “Comparison of Internal Disc Decompression (IDD) Vs. a Standardized Non-Surgical Treatment Program for Chronic Low Back Pain Secondary to Mild to Moderate Degenerative Disc Disease”

This study is looking at a new machine called the Accu-Spina which administers internal disc decompression by following a computer program. This non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

This study is a randomized trial where out of every 3 people, 2 will receive IDD therapy and 1 will have standardized physical therapy. Patients are given surveys to complete that ask about how their back pain is affecting their quality of life before starting treatment, 6 weeks after starting treatment, and 3, 6, and 12 months after starting treatment. If at the 6 week point, the patient and doctor do not think the current treatment is working well enough, the patient is given the option to try the other treatment.

Intervention(s) in this Clinical Trial

• Device: Accu-Spina Device/IDD therapy
• Procedure: Physical Therapy

Primary Measures

• Compare the changes in functional and pain scores in patients with chronic low back pain, which are alternatively treated with a standardized non-surgical treatment program.

Secondary Measures

• Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.

Inclusion Criteria:

• Chronic low back pain for > 3 months due to mild to moderate disc degeneration, lumbar spondylosis, and facet arthropathy without leg pain based on the physician's history and physical and imaging studies
• Over 18 years old
• Able to provide written informed consent

Exclusion Criteria:

• Infection, neurological deficits, systemic disease that would affect treatment outcome such as inflammatory joint diseases; malignancies with involvement in the musculoskeletal system
• Evidence of severe neural compression on imaging studies, i.e. spinal stenosis or large herniated disc
• Uncontrolled mood disorder
• History of drug or substance abuse
• Lumbar spine pathology requiring surgical intervention
• Previous spine surgery of the lumbar spine, except discectomies >12 months
• Improvement with similar non-surgical treatments in the last 3 months
• Active litigation, workers compensation
• Females whom are pregnant

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Emory University

Overall Clinical Trial Officials and Contacts

Michael K Schaufele, M.D. Principal Investigator Emory University  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00165893

Study ID Number: 079-2004

ClinicalTrials.gov Identifier: NCT00165893

Health Authority: United States: Food and Drug Administration

Manufacturer's web site with helpful information on IDD therapy.