Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
NCT ID: NCT02116075
Last Updated: 2015-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Epidural Steroid
80mg depo-medrol 9mL 1% lidocaine
Epidural Prolotherapy
caudal injection of 10mL 5% dextrose
Epidural Prolotherapy
10ml of 5% generic dextrose
Epidural Steroid
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine
Interventions
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Epidural Prolotherapy
caudal injection of 10mL 5% dextrose
Epidural Steroid
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Naveed Natanzi
FED
Responsible Party
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Naveed Natanzi
Resident Physician
Locations
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Veteran'S Affairs Healthy System
Long Beach, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SC2626
Identifier Type: -
Identifier Source: org_study_id
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