Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.

no Conditions Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02116075
• Other study ID #: SC2626
• Status: Recruiting
• Phase: Phase 2
• First received: April 9, 2014
• Last updated: June 1, 2015
• Start date: January 2015

Study information

• Verified date: June 2015
• Source: VA Long Beach Healthcare System
• Contact: Naveed M Natanzi, DO
• Phone: 8186059333
• Email: NNATANZI[@]UCI.EDU
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• no Conditions

Intervention

Procedure:
• Epidural Prolotherapy
caudal injection of 10mL 5% dextrose
• Epidural Steroid
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine

Locations

Country	Name	City	State
United States	Veteran'S Affairs Healthy System	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Naveed Natanzi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief as measured by VAS pain scale.		1 year	No
Secondary	Change in the frequency and amount of opioid use.		1 year	No
Secondary	Disability score as determined by Oswstery questionnaire.		1 year	No