Clinical trial NCT01547364: Caudal Epidural Injection of Dextrose For Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Back Pain Lower Back Chronic
Keywords: Caudal
Epidural
Dextrose
Analgesia
TRVP1
Lead sponsor: Smigel, Liza, M.D.
Sponsor class: INDIV
First posted: 2012-03-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain
timeFrame: 20 minutes
Secondary outcomes:
measure: Change from Baseline to 1 year in NRS for Pain
timeFrame: 1 year
measure: Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method
timeFrame: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.
Other outcomes:
Locations:
city: Hilo
country: United States
facility: Liza Smigel, M.D.
state: Hawaii
Study officials:
affiliation: Liza Smigel, M.D., P.A.
name: Liza Smigel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: