CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
functional anesthetic discography +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00443781
NCT00443781Phase 4Completed
CompareCT.gov

Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain

Medtronic Spine LLC·interventional·Posted Mar 6, 2007·Updated Jan 5, 2021

In Brief

A Phase 4 clinical trial evaluating functional anesthetic discography and provocative discography for Low Back Pain. Completed, enrolled 62 participants across 10 sites.

Detailed Summary

The primary objective of this study is to document and compare diagnostic test results and procedure safety in subjects undergoing both Functional Anaesthetic DiscographyTM (F.A.D.) and provocative discography (PD) and determine the appropriateness of the F.A.D. procedure data collection script for use in a larger clinical trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2007
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.3 years ago

Interventions

functional anesthetic discographyprocedure

Functional Anesthetic Discography (F.A.D.) involves the placement and anchoring of a small catheter into a disc. After placement, functional testing is performed, in which the subject elicits his/her back pain via functional maneuvers or postures. Local anaesthetic is then delivered into the target disc through the catheter and the effect on functional back pain is noted.

provocative discographyprocedure

Provocative discography (PD) has been used as a preoperative diagnostic tool for patients with back pain attributed to degenerative disc disease considering lumbar disc surgery. During PD, a clinically suspected disc is accessed with a needle and injected under pressure with radiopaque contrast dye. The subject rates his/her experience of pain for intensity and whether the pain is exactly the same as ("concordant") or different from ("not concordant" or "discordant") typical back pain.