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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2005 by Emory University. Recruitment status was Active, not recruiting

First Received on September 9, 2005. Last Updated on December 9, 2005 History of Changes

Sponsor:	Emory University
Collaborator:	North American Medical Corporation
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00165893

Purpose

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.

Condition	Intervention	Phase
Degenerative Disc Disease	Device: Accu-Spina Device/IDD therapy Procedure: Physical Therapy	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome 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 Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	September 2004
Estimated Study Completion Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165893

Sponsors and Collaborators

Emory University

North American Medical Corporation

Investigators

Principal Investigator:

Michael K Schaufele, M.D.

Emory University

More Information

Additional Information:

Manufacturer's web site with helpful information on IDD therapy. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00165893 History of Changes
Other Study ID Numbers:	079-2004
Study First Received:	September 9, 2005
Last Updated:	December 9, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

low back pain
DDD

Additional relevant MeSH terms:

Back Pain
Spinal Diseases
Low Back Pain
Intervertebral Disk Degeneration
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012