Caudal Epidural Injection of Dextrose For Low Back Pain

NCT01547364 | Completed Phase 2 DMC

• 1 other identifier: SweetCaudal
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The purposes of the study are to

1. 1.Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
2. 2.Determine if cumulative benefit results from caudal dextrose injection.
3. 3.Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.

Conditions

Back Pain Lower Back Chronic

Keywords

Caudal; Epidural; Dextrose; Analgesia; TRVP1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline to 1 year in NRS for Pain

  1 year

• 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.

Study Arms (2)

Caudal Saline

PLACEBO COMPARATOR

Drug: Saline

Caudal Dextrose

ACTIVE COMPARATOR

Drug: Dextrose

Interventions

Saline DRUG

Injection of 10 ml of normal saline into the caudal epidural space

Also known as: Normal Saline

Caudal Saline

Dextrose DRUG

Injection of 10 ml or dextrose 5% in water into the caudal epidural space

Also known as: D5W

Caudal Dextrose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable neurologic function

Sponsors & Collaborators

• Smigel, Liza, M.D.: lead

Study Sites (1)

Liza Smigel, M.D.

Hilo, Hawaii, 96720, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Sodium Chloride; Saline Solution; Glucose

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Liza Smigel, M.D.

  Liza Smigel, M.D., P.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Liza Smigel, M.D.

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 7, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2015
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (1)