Caudal Epidural Injection of Dextrose For Low Back Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Back Pain Lower Back Chronic |
Drug: Saline Drug: Dextrose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]Caudal epidural injection of D5W will result in more analgesia at 20 minutes than epidural injection of normal saline.
- Change from Baseline to 1 year in NRS for Pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically. ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Liza Smigel, M.D. | (808) 933-3444 | lizasmigel@gmail.com |
| Contact: K. Dean D Reeves, M.D. | (913) 362-1600 | DeanReevesMD@gmail.com |
| United States, Hawaii | |
| Liza Smigel, M.D. | Recruiting |
| Hilo, Hawaii, United States, 96720 | |
| Contact: Liza Smigel, M.D. 808-936-4059 LizaSmigel@gmail.com | |
| Principal Investigator: Liza Smigel, M.D. | |
| Principal Investigator: | Liza Smigel, M.D. | Liza Smigel, M.D., P.A. |
More Information
No publications provided
| Responsible Party: | Liza Smigel, M.D., Smigel, Liza, M.D. |
| ClinicalTrials.gov Identifier: | NCT01547364 History of Changes |
| Other Study ID Numbers: | SweetCaudal |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Smigel, Liza, M.D.:
|
Caudal Epidural Dextrose Analgesia TRVP1 |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013