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| Name | Class |
|---|---|
| North American Medical Corporation | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Spina Device/IDD therapy | Device | |||
| Physical Therapy | Procedure |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael K Schaufele, M.D. | Emory University | Principal Investigator |
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| Label | URL |
|---|---|
| Manufacturer's web site with helpful information on IDD therapy. | View source |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001416 | Back Pain |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |