Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
Status unconfirmed · Phase 2
Conditions studied: no Conditions
In brief
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
Key facts
- Study ID
- NCT02116075
- Run by
- Naveed Natanzi
- People needed
- 50
- Starts
- 2015-01-01
- Last updated by the study team
- 2015-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings.
- 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.)
- Men or women age greater than or equal to 18 years.
- No significant alcohol use (7 or fewer drinks per week).
- Patient has a history of at least 2 failed epidural CS injections.
You may not qualify if…
- 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
- Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
- History of Malignancy
- 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.
Where it is running
- Veteran'S Affairs Healthy System — Long Beach, California, United States (enrolling)
Full record on ClinicalTrials.gov
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