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Completed

NCT Number: NCT01547364

Caudal Epidural Injection of Dextrose For Low Back 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liza Smigel, M.D.

Hilo, Hawaii, 96720, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline

Drug

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

Other names: Normal Saline

Dextrose

Drug

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

Other names: D5W

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Smigel, Liza, M.D.

Indiv

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Mar 7, 2012
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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