Caudal Epidural Injection of Dextrose For Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Drug: Saline; Drug: Dextrose

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
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Hilo, Hawaii, United States, 96720
      • Liza Smigel, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Caudal Saline	Drug: Saline; Injection of 10 ml of normal saline into the caudal epidural space; Other Names: Normal Saline
ACTIVE_COMPARATOR: Caudal Dextrose	Drug: Dextrose; Injection of 10 ml or dextrose 5% in water into the caudal epidural space; Other Names: D5W

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to 1 year in NRS for Pain	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)	1 year
Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method	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.	Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.

Collaborators and Investigators

• Sponsor: Smigel, Liza, M.D.
• Investigators: Principal Investigator: Liza Smigel, M.D., Liza Smigel, M.D., P.A.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (ESTIMATE): March 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Analgesia; Epidural; Caudal; Dextrose; TRVP1
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: SweetCaudal