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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00165893
Other study ID # 0079-2004
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated December 23, 2013
Start date September 2004
Est. completion date November 2006

Study information

Verified date December 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Accu-Spina Device/IDD therapy

Procedure:
Physical Therapy


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Emory University North American Medical Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.
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