Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.

NCT ID: NCT02116075

Last Updated: 2015-06-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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

Detailed Description

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Conditions

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no Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epidural Steroid

80mg depo-medrol 9mL 1% lidocaine

Group Type EXPERIMENTAL

Epidural Prolotherapy

Intervention Type PROCEDURE

caudal injection of 10mL 5% dextrose

Epidural Prolotherapy

10ml of 5% generic dextrose

Group Type ACTIVE_COMPARATOR

Epidural Steroid

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Epidural Steroid

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naveed Natanzi

FED

Sponsor Role lead

Responsible Party

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Naveed Natanzi

Resident Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Veteran'S Affairs Healthy System

Long Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Naveed M Natanzi, DO

Role: CONTACT

8186059333

Facility Contacts

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NAVEED NATANZI, DO

Role: primary

Other Identifiers

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SC2626

Identifier Type: -

Identifier Source: org_study_id

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