Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01547364
Study type Interventional
Source Smigel, Liza, M.D.
Contact
Status Completed
Phase Phase 2
Start date February 2012
Completion date November 2015

See also
  Status Clinical Trial Phase
Completed NCT01914666 - An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain Phase 3
Completed NCT01761617 - Yoga Dosing Study for Chronic Low Back Pain N/A
Completed NCT03338192 - Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
Active, not recruiting NCT03106740 - Evaluating the Role of Neuroinflammation in Low Back Pain Phase 2
Completed NCT02960269 - Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing N/A
Completed NCT04203888 - Personalized Trial for Chronic Lower Back Pain N/A
Not yet recruiting NCT05704751 - EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Completed NCT06351774 - Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain N/A
Completed NCT01855919 - A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain Phase 3
Terminated NCT01865539 - Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain N/A
Enrolling by invitation NCT05386212 - The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures
Completed NCT03299192 - Tai Chi for Chronic Low Back Pain in Older Adults N/A
Completed NCT01081912 - Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain Phase 3
Completed NCT04468074 - Virtual Reality Treatment for Adults With Chronic Back Pain N/A
Completed NCT01343927 - Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations N/A
Terminated NCT01125917 - Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015 Phase 3
Completed NCT01329861 - Internet-based Cognitive Behavioural Treatment for Chronic Back Pain N/A
Enrolling by invitation NCT05413070 - Quality Improvement re: Choosing Wisely Back Pain Measures
Recruiting NCT04893720 - The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Recruiting NCT05953155 - YOga for Patients With Chronic BACK Pain and Poor PROgnosis N/A