Back Pain Lower Back Chronic Clinical Trial
Official title:
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
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.
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.
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