Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
1 other identifier
interventional
50
1 country
1
Brief Summary
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedJune 3, 2015
June 1, 2015
1.8 years
April 9, 2014
June 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pain relief as measured by VAS pain scale.
1 year
Secondary Outcomes (2)
Change in the frequency and amount of opioid use.
1 year
Disability score as determined by Oswstery questionnaire.
1 year
Study Arms (2)
Epidural Steroid
EXPERIMENTAL80mg depo-medrol 9mL 1% lidocaine
Epidural Prolotherapy
ACTIVE COMPARATOR10ml of 5% generic dextrose
Interventions
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naveed Natanzilead
Study Sites (1)
Veteran'S Affairs Healthy System
Long Beach, California, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Resident Physician
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 16, 2014
Study Start
January 1, 2015
Primary Completion
November 1, 2016
Last Updated
June 3, 2015
Record last verified: 2015-06