NCT00750191

Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Baylis Medical Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Each patient was assigned to one of the two groups: IDB or Sham. On the day of the procedure, an IV was inserted in pre-procedural area and patient transported to the procedure room. The procedure will be completed under fluoroscopy in prone position. Patients were given 1-4 mg of midazolam for relaxation before the procedure and, if needed, 50-100 mcg of fentanyl IV during the procedure. The patients was randomly assigned to treatment or placebo using computer-generated codes maintained in sequentially numbered opaque envelopes. The physician performing procedure was informed of the assignment. In IDB group, guided by the fluoroscopic imaging, two transdiscal probes was positioned in the posterior annulus using a posterolateral, oblique approach. First, two electrically insulated 17G transdiscal introducers was used to gain an access to the disc space. Than, two radiofrequency probes will be positioned through each of the introducers bilaterally to create a bipolar configuration. Placement of the transdiscal probes within the disc annulus will be confirmed using oblique, lateral, and anterior-posterior fluoroscopic images. Sham group had their introducers and electrodes positioned just outside of the disc. This was also be documented using fluoroscopy. Investigator attached the electrodes to inactive heater control device that provide a similar auditory and visual experience for the patient. Patients were therefore remain blinded to actual treatment and physician performing procedure was not involved in patient's follow-up. Patients were awake and communicating with the physician conducting the procedure and if pain in legs were present and increased during the procedure, the heating protocol would be stopped. Following completion of procedure the patient was transferred to recovery and monitored for 45 minutes, then discharged home with instructions. The patients were followed over a period of 12 months.

Detailed description

Back Pain

Conditions

• Lower Back Pain

Interventions

Type	Name	Description
DEVICE	The Transdiscal Radiofrequency Annuloplasty	Adjustment in dosage form, frequency and or duration.
DEVICE	The Transdiscal Radiofrequency Annuloplasty	interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2008-09-10
• Last updated: 2014-01-08
• Results posted: 2014-01-08

Locations

2 sites across 1 country: United States