Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.

Naveed Natanzi

Status and phase: Unknown; Phase 2

Conditions: no Conditions

Treatments: Procedure: Epidural Prolotherapy; Procedure: Epidural Steroid

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02116075

SC2626

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Epidural Steroid

Experimental group

Description:

80mg depo-medrol 9mL 1% lidocaine

Treatment:

Procedure: Epidural Prolotherapy

Epidural Prolotherapy

Active Comparator group

Description:

10ml of 5% generic dextrose

Treatment:

Procedure: Epidural Steroid