Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:January 2015
Contact:Naveed M Natanzi, DO
Email:NNATANZI@UCI.EDU
Phone:8186059333

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Study comparing caudal prolotherapy to conventional steroid for chronic low back pain


INCLUSION CRITERIA

1. Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve
root level or below with consistent MRI or X ray findings.

2. Evidence of low back pain base upon one or more of the following:

i. Lumbar back pain episodes lasting greater than 6 months and current pain level is
greater than 6/10 on VAS.

ii. Has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral
analgesia, acupuncture, etc.)

3. Men or women age greater than or equal to 18 years.

4. No significant alcohol use (7 or fewer drinks per week).

5. Patient has a history of at least 2 failed epidural CS injections.

EXCLUSION CRITERIA

1. Treatment risk factors including one or more of the following:

i. Unstable or symptomatic cardiac complaints ii. Unstable or symptomatic respiratory
complaints iii. Unable to reliably comprehend the protocol or reliably record data

2. Pregnancy. A serum pregnancy test must be performed and negative in all women of
child bearing potential within 2 weeks prior to enrollment.

3. History of Malignancy

4. Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease,
polyneuropathy) or psychosocial condition that in the opinion of the investigator,
could jeopardize the subject's participation, and compliance with the study criteria.
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Long Beach, California
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