Trial | NCT01547364  Report issue

Title

Caudal Epidural Injection of Dextrose For Low Back Pain
Blinded Analgesic Effect and 1 Year Outcome of Caudal D5W Injection in All-Comers With Chronic Low Back Pain and Either Buttock or Leg Pain

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    35
Objective: The purposes of the study are to

Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
Determine if cumulative benefit results from caudal dextrose injection.
Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.
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:

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

More comfort with injection.
Less need for radiographic exposure, in that needle placement is quicker and easier, allowing for less fluoroscopy time.
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.
Study Started
Feb 29
2012
Primary Completion
Oct 31
2013
Study Completion
Nov 30
2015
Last Update
Apr 30
2018

Drug Saline

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

  • Other names: Normal Saline

Drug Dextrose

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

  • Other names: D5W

Caudal Saline Placebo Comparator

Caudal Dextrose Active Comparator

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
No Results Posted