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

This study has been completed.
Sponsor:
Collaborator:
North American Medical Corporation
Information provided by (Responsible Party):
Kyle Webb, Emory University
ClinicalTrials.gov Identifier:
NCT00165893
First received: September 9, 2005
Last updated: December 23, 2013
Last verified: December 2013
  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 4

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 (DDD)

Resource links provided by NLM:


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
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Kyle Webb, Research Administrator, Emory University
ClinicalTrials.gov Identifier: NCT00165893     History of Changes
Other Study ID Numbers: 0079-2004
Study First Received: September 9, 2005
Last Updated: December 23, 2013
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 Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 27, 2014