Caudal Epidural Injection of Dextrose For Low Back Pain

Sponsor

Smigel, Liza, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT01547364

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Lower Back Chronic	Drug: Saline Drug: Dextrose	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain [20 minutes]
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 [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)
Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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