NCT01263054

Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain

A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Halyard Health · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will be compared against medical management (standard of care).

Detailed description

The intervertebral discs serve as joints between the vertebral bodies, providing both structural support and flexibility to the spinal column. Intervertebral discs do not remain structurally intact over a lifetime and degenerate as a natural part of aging. Degenerated discs do not react to stresses and forces the same as healthy discs. When too much stress is applied to a degenerated disc, tears can result. Evidence suggests that when a tear is present, sensory nerve endings can grow into the tear and transmit pain. The TransDiscal System (TDS) is a medical device that is used in a procedure called Disc Biacuplasty and is currently available in the United States and throughout the world. The TDS enables the back of the disc to be heated to high enough temperatures to ablate the nerves inside that are transmitting pain, while maintaining low enough temperatures to prevent damage to surrounding tissues. The TDS uses two electrodes, located at the ends of two thin probes, which are placed on both sides of the back of the intervertebral disc by inserting them through the skin into the disc using x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature. The study evaluates a modified heating protocol than what is currently in clinical use which should allow for a larger area of the back of the disc to be heated.

Conditions

• Back Pain

Interventions

Type	Name	Description
DEVICE	TransDiscal System	Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
OTHER	Medical Management	Standard medical management, physical therapy, and lifestyle changes.

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-12-01
• Completion: 2015-04-01
• First posted: 2010-12-20
• Last updated: 2018-07-10
• Results posted: 2016-03-09

Locations

9 sites across 1 country: United States