Caudal Epidural Injection of Dextrose For Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Saline; Dextrose
Intervention type(s): Drug; Drug
Intervention description(s): Injection of 10 ml of normal saline into the caudal epidural space; Injection of 10 ml or dextrose 5% in water into the caudal epidural space
Other intervention name(s): Normal Saline; D5W
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Caudal; Epidural; Dextrose; Analgesia; TRVP1