Recruiting
Phase 2

Caudal Corticosteroid vs. Dextrose

Sponsor:

Naveed Natanzi

Code:

NCT02116075

Conditions

no Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epidural Prolotherapy

Epidural Steroid

Study Details

Brief summary:

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

Conditions

no Conditions

Study ID

NCT02116075

Start date

Jan, 2015

Status verified date

Jun, 2015

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epidural Steroid

80mg depo-medrol 9mL 1% lidocaine

active comparator: Epidural Prolotherapy

10ml of 5% generic dextrose

Interventions

Epidural Prolotherapy

caudal injection of 10mL 5% dextrose

Epidural Steroid

caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine

Primary outcome measure

  • Pain relief as measured by VAS pain scale. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Naveed M Natanzi, DO

8186059333NNATANZI@UCI.EDU

Locations

Veteran'S Affairs Healthy System

Recruiting

Long Beach, California, United States

Contacts

NAVEED NATANZI, DO

NNATANZI@UCI.EDU

More Information

Sponsor

Naveed Natanzi

Last update posted

Jun 3, 2015

Last verified

Jun, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Naveed Natanzi on 2015-06-03.