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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165893
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 24, 2013
North American Medical Corporation
Information provided by (Responsible Party):
Kyle Webb, 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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: Accu-Spina Device/IDD therapy Procedure: Physical Therapy Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 (DDD)
Study Start Date : September 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165893

Sponsors and Collaborators
Emory University
North American Medical Corporation
Principal Investigator: Michael K Schaufele, M.D. Emory University

Responsible Party: Kyle Webb, Research Administrator, Emory University Identifier: NCT00165893     History of Changes
Other Study ID Numbers: 0079-2004
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Kyle Webb, Emory University:
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Spinal Diseases
Intervertebral Disc Degeneration
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases