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Trial #NCT01547364
Back Pain Lower Back Chronic Clinical Trials

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
Study ID: SweetCaudal; Source: Smigel, Liza, M.D.
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
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Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country United States
Study type Interventional
Enrollment 35
Start date February 2012
Completion date November 2013
Phase Phase 2
Sponsor Smigel, Liza, M.D.
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.
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:
Gender: Both
Age: 18 Years - 75 Years
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
Outcome:
Primary outcome
  • 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.
    Time frame: 20 minutes
Secondary outcome
  • 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)
    Time frame: 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.
    Time frame: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.
Contacts:
  • Liza Smigel, M.D.; Liza Smigel, M.D., P.A. (Principal Investigator)
Location Country Status
Liza Smigel, M.D. Hilo, Hawaii United States
Sponsors:
  • Smigel, Liza, M.D. - (Lead Sponsor)

Related trials: Terms
  • TRVP1
  • Dextrose
  • Analgesia
  • Caudal
  • Epidural
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