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Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Steroid | Experimental | 80mg depo-medrol 9mL 1% lidocaine |
|
| Epidural Prolotherapy | Active Comparator | 10ml of 5% generic dextrose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Prolotherapy | Procedure | caudal injection of 10mL 5% dextrose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief as measured by VAS pain scale. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the frequency and amount of opioid use. | 1 year | |
| Disability score as determined by Oswstery questionnaire. | 1 year |
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INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naveed M Natanzi, DO | Contact | 8186059333 | NNATANZI@UCI.EDU |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veteran'S Affairs Healthy System | Recruiting | Long Beach | California | United States |
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| Epidural Steroid |
| Procedure |
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine |
|