Back to resultsComparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
Primary Purpose
Degenerative Disc Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Accu-Spina Device/IDD therapy
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring low back pain, DDD
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00165893
First Posted
September 9, 2005
Last Updated
December 23, 2013
Sponsor
Emory University
Collaborators
North American Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00165893
Brief Title
Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
North American Medical Corporation
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
low back pain, DDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Accu-Spina Device/IDD therapy
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Schaufele, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.iddtherapy.com
Description
Manufacturer's web site with helpful information on IDD therapy.
Learn more about this trial
Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
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