NCT00443781

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Medtronic Spine LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	functional anesthetic discography	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.
PROCEDURE	provocative discography	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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-03-06
• Last updated: 2021-01-05
• Results posted: 2010-08-23

Locations

10 sites across 1 country: United States