Study:
A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
Rationale:
n/a
Purpose:
Each patient will be assigned to one of the two groups: IDB or Sham. On the day of the
procedure, an IV will be inserted in pre-procedural area and patient transported to the
procedure room. The procedure will be completed under fluoroscopy in prone position.
Patients will be 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 will be randomly
assigned to treatment or placebo using computer-generated codes maintained in sequentially
numbered opaque envelopes. The physician performing procedure will be informed of the
assignment. In IDB group, guided by the fluoroscopic imaging, two transdiscal probes will be
positioned in the posterior annulus using a posterolateral, oblique approach. First, two
electrically insulated 17G transdiscal introducers will be 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 will have their introducers and
electrodes positioned just outside of the disc. This will also be documented using
fluoroscopy. Investigator will attach the electrodes to inactive heater control device that
provide a similar auditory and visual experience for both the patient. Patients will
therefore remain blinded to actual treatment and physician performing procedure will not be
involved in patient`s follow-up. Patients will be awake and communicating with the physician
conducting the procedure and if pain in legs is present and increases during the procedure,
the heating protocol will be stopped. Following completion of procedure the patient will be
transferred to recovery and monitored for 45 minutes, then discharged home with
instructions. The patients will be followed over a period of 12 months.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Lower Back Pain |
Device: The Transdiscal Radiofrequency Annuloplasty
Device: The Transdiscal Radiofrequency Annuloplasty |
Phase 1 |
Verified by
Baylis Medical Company
February, 2013
Sponsored by: Baylis Medical Company
Information provided by: Baylis Medical Company
ClinicalTrials.gov identifier: NCT00750191
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Cleveland Clinic Pain Management
Cleveland, Ohio 44195
United States
Leonardo Kapural, MD., Principal Investigator
Bruce Vrooman, M.D.., Principal Investigator