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Caudal Epidural Injection of Dextrose For Low Back Pain

Primary Purpose

Back Pain Lower Back Chronic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Saline
Dextrose
Sponsored by
Smigel, Liza, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Caudal, Epidural, Dextrose, Analgesia, TRVP1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Liza Smigel, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Caudal Saline

Caudal Dextrose

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.

Full Information

First Posted
February 27, 2012
Last Updated
April 27, 2018
Sponsor
Smigel, Liza, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01547364
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Smigel, Liza, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: The purposes of the study are to 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. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
Keywords
Caudal, Epidural, Dextrose, Analgesia, TRVP1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caudal Saline
Arm Type
Placebo Comparator
Arm Title
Caudal Dextrose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal Saline
Intervention Description
Injection of 10 ml of normal saline into the caudal epidural space
Intervention Type
Drug
Intervention Name(s)
Dextrose
Other Intervention Name(s)
D5W
Intervention Description
Injection of 10 ml or dextrose 5% in water into the caudal epidural space
Primary Outcome Measure Information:
Title
Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain
Description
Caudal epidural injection of D5W will result in more analgesia at 20 minutes than epidural injection of normal saline.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Change from Baseline to 1 year in NRS for Pain
Description
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)
Time Frame
1 year
Title
Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method
Description
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.
Time Frame
Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liza Smigel, M.D.
Organizational Affiliation
Liza Smigel, M.D., P.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liza Smigel, M.D.
City
Hilo
State/Province
Hawaii
ZIP/Postal Code
96720
Country
United States

12. IPD Sharing Statement

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Caudal Epidural Injection of Dextrose For Low Back Pain

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