Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty - Full Text View

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.

Condition	Intervention	Phase
Lower Back Pain	Device: The Transdiscal Radiofrequency Annuloplasty	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Baylis Medical Company:

Primary Outcome Measures:

Our goal is to assess the effectiveness of Intradiscal Biacuplasty [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	September 2007
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intradiscal Biacuplasty Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature. After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure.	Device: The Transdiscal Radiofrequency Annuloplasty Adjustment in dosage form, frequency and or duration. Other Name: Intradiscal Biacuplasty Active Comparator
Placebo Comparator: Sham The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure. The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB.	Device: The Transdiscal Radiofrequency Annuloplasty interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A Other Name: Sham: Placebo Comparator

Arms

Assigned Interventions

Active Comparator: Intradiscal Biacuplasty

Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.

After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure.

Device: The Transdiscal Radiofrequency Annuloplasty

Adjustment in dosage form, frequency and or duration.

Other Name: Intradiscal Biacuplasty Active Comparator

Placebo Comparator: Sham

The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.

The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB.

Device: The Transdiscal Radiofrequency Annuloplasty

interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A

Other Name: Sham: Placebo Comparator

Detailed Description:

Back Pain

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The inclusion criteria will be as follows:
- Age 18 + years
- History of chronic low back pain unresponsive to nonoperative care (including physical therapy and anti-inflammatory medication) for longer than 6 months of at least 5 on VAS
- No surgical interventions within the last 3 months
- Back pain more than leg pain which is commonly exacerbated by sitting
- Pain reproduction present on provocative discography in degenerated disc but not in control discs
- Disc height at least 50% of adjacent control disc
- Evidence of single level degenerative disc disease or two level disease without evidence of additional degenerative changes in other disc spaces on MRI

Exclusion Criteria:

The exclusion criteria are :
- Evidence of compressive radiculopathy with predominant leg pain
- Nucleus pulposus herniation on the MRI
- Disc bulges > 5 mm
- Prior lumbar surgery of any kind
- Presence of concordant cervical or thoracic pain
- Symptoms or signs of the lumbar canal stenosis
- Evidence of structural abnormality at the symptomatic level like spondylolisthesis
- Chronic severe conditions such as rheumatoid arthritis and fibromyalgia
- Patients with pending workers compensation claim, litigation or disability income remuneration
- Psychological issues by exam or history
- Beck Depression Inventory (BDI) >20
- Pregnancy
- Systemic infection or localized infection at the anticipated entry needle site
- Allergies to contrast media or to any medication to be used in the procedure
- Traumatic spinal fracture
- History of coagulopathy, unexplained bleeding
- Progressive neurological deficits
- History of opioid abuse
- Presence of free disc fragments on MRI
- More than 2 discs degenerated on MRI
- Immunosuppression (eg. AIDS, cancer, diabetes, other surgery within last 3 months)
- Smoking
- BMI (body mass index) >30 kg/m2
- Subject unwilling to consent to the study
- Participation in another investigation within 30 days of signing informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750191

Locations

United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Pain Management
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Baylis Medical Company

Investigators

Principal Investigator:	Leonardo Kapural, MD	Center for Clinical Research
Principal Investigator:	Bruce Vrooman, M.D.	The Cleveland Clinic

More Information

No publications provided by Baylis Medical Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kapural L, Vrooman B, Sarwar S, Krizanac-Bengez L, Rauck R, Gilmore C, North J, Girgis G, Mekhail N. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013 Mar;14(3):362-73. doi: 10.1111/pme.12023. Epub 2012 Dec 28.

Responsible Party:	Baylis Medical Company
ClinicalTrials.gov Identifier:	NCT00750191 History of Changes
Other Study ID Numbers:	IRB 07-594, IRB 07-594
Study First Received:	September 9, 2008
Last Updated:	February 4, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylis Medical Company:

Lower Back Pain

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013