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

Degenerative Disc Disease Clinical Trial

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 (DDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165893
• Other study ID #: 0079-2004
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: December 23, 2013
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: December 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain
• Spinal Diseases

Intervention

Device:
• Accu-Spina Device/IDD therapy

Procedure:
• Physical Therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	North American Medical Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.