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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Accu-Spina Device/IDD therapy
* Procedure: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Accu-Spina Device/IDD therapy|nan|
|Procedure: Physical Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DDD, low back pain