Caudal Epidural Injection of Dextrose For Low Back Pain

NCT ID: NCT01547364

Last Updated: 2018-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-11-30

Brief Summary

Objective: The purposes of the study are to

1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.

2. Determine if cumulative benefit results from caudal dextrose injection.

3. Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.

Detailed Description

Injection of dextrose into the epidural space as an admixture with various steroids and anesthetic has been utilized for years for purposes of altering the specific gravity of the injectate. No safety issues or concerns have been raised about the dextrose component inclusion but a separate therapeutic effect of dextrose has not heretofore been considered. Recently dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). An analgesic effect of dextrose on chronic pain in the presence of painful sensory nerves has been observed with injection of D5W without anesthetic. That effect begins within seconds clinically. Physicians have empirically trialed D5W for epidural injection in a 10 ml volume and found that marked or complete analgesia of chronic low back and leg pain results in the majority of patients within 15 minutes. An empirical consecutive patient date collection has demonstrated that this initial effect lasts for 2 to 48 hours, and that the effect begins to sustain after 2-3 sessions. For this reason, the current study is designed with the the first two objectives:

1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.

2. Determine if cumulative benefit results from caudal dextrose injection.

In addition to determining potential benefit from caudal epidural of dextrose, the accuracy of a simple vertical approach to injection of dextrose is to be evaluated. If this vertical approach is accurate it will allow for

1. More comfort with injection.

2. Less need for radiographic exposure, in that needle placement is quicker and easier, allowing for less fluoroscopy time.

3. Potential for blind injection of solutions that do not include anesthetic or particulate matter, increasing potential applicability of caudal dextrose injection to situations in which fluoroscopy is not available.

Conditions

Back Pain Lower Back Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Caudal Saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Injection of 10 ml of normal saline into the caudal epidural space

Caudal Dextrose

Group Type: ACTIVE_COMPARATOR

Dextrose

Intervention Type: DRUG

Injection of 10 ml or dextrose 5% in water into the caudal epidural space

Interventions

Saline

Injection of 10 ml of normal saline into the caudal epidural space

Intervention Type: DRUG

Dextrose

Injection of 10 ml or dextrose 5% in water into the caudal epidural space

Intervention Type: DRUG

Other Intervention Names

Normal Saline; D5W

Eligibility Criteria

Inclusion Criteria

• More than 3 months of back pain
• Some pain below the iliac crest (Either in buttock or in leg)
• At least one conservative (non-injection) modality of treatment to include physical therapy, chiropractic/osteopathic manipulation, exercises, drug therapy, and relative rest.
• Opiate use absent or controlled
• Psychiatric history absent or controlled
• Current medical stability
• Absent steroid use history or no allergy or intolerance to steroid use

Exclusion Criteria

• Unstable neurologic function

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smigel, Liza, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Liza Smigel, M.D.

Liza Smigel, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liza Smigel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Liza Smigel, M.D., P.A.

Locations

Liza Smigel, M.D.

Hilo, Hawaii, United States

Countries

United States

Other Identifiers

SweetCaudal

Identifier Type: -

Identifier Source: org_study_id