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

Emory University

Status and phase: Completed; Phase 4

Conditions: Degenerative Disc Disease

Treatments: Procedure: Physical Therapy; Device: Accu-Spina Device/IDD therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00165893

0079-2004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)