Caudal Epidural Injection of Dextrose For Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547364
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
Liza Smigel, M.D., Smigel, Liza, M.D.

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.

Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Drug: Saline Drug: Dextrose Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Caudal Saline Drug: Saline
Injection of 10 ml of normal saline into the caudal epidural space
Other Name: Normal Saline
Active Comparator: Caudal Dextrose Drug: Dextrose
Injection of 10 ml or dextrose 5% in water into the caudal epidural space
Other Name: D5W

Primary Outcome Measures :
  1. Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain [ Time Frame: 20 minutes ]
    Caudal epidural injection of D5W will result in more analgesia at 20 minutes than epidural injection of normal saline.

Secondary Outcome Measures :
  1. Change from Baseline to 1 year in NRS for Pain [ Time Frame: 1 year ]
    Those with consistent analgesia after caudal epidural dextrose will note cumulative benefit on pain and disability that will exceed 1.5 times the MCID for pain and disability in low back pain. (NRS change of 3 or more)

  2. Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method [ Time Frame: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically. ]
    Blind use of the Rosen technique for vertical short needle caudal epidural injection will produce an epidurogram pattern 80% of the time upon first needle placement.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547364

United States, Hawaii
Liza Smigel, M.D.
Hilo, Hawaii, United States, 96720
Sponsors and Collaborators
Smigel, Liza, M.D.
Principal Investigator: Liza Smigel, M.D. Liza Smigel, M.D., P.A.

Responsible Party: Liza Smigel, M.D., Smigel, Liza, M.D. Identifier: NCT01547364     History of Changes
Other Study ID Numbers: SweetCaudal
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Liza Smigel, M.D., Smigel, Liza, M.D.:

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms