Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease

Phase 4

Completed

• Conditions: Degenerative Disc Disease

• Registration Number: NCT00165893
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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