Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

Tracking Information
First Submitted Date ICMJE	September 9, 2008
First Posted Date ICMJE	September 10, 2008
Results First Submitted Date	September 13, 2013
Results First Posted Date	January 8, 2014
Last Update Posted Date	January 8, 2014
Study Start Date ICMJE	September 2007
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 20, 2013)	Physical Function [ Time Frame: 6 months ]; Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component. Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome).
Original Primary Outcome Measures ICMJE; (submitted: September 9, 2008)	Our goal is to assess the effectiveness of Intradiscal Biacuplasty [ Time Frame: 1 year ]
Change History	Complete list of historical versions of study NCT00750191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 20, 2013)	Pain [ Time Frame: 6 months ]Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome); Disability [ Time Frame: 6 months ]Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE; (submitted: November 20, 2013)	Opioid Usage [ Time Frame: 6 months ]; Patient reported Opioid usage (converted to morphine equivalents)
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
Official Title ICMJE	A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
Brief 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
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Lower Back Pain
Intervention ICMJE	Device: The Transdiscal Radiofrequency Annuloplasty Adjustment in dosage form, frequency and or duration. Other Name: Intradiscal Biacuplasty Active Comparator; Device: The Transdiscal Radiofrequency Annuloplasty interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A Other Name: Sham: Placebo Comparator
Study Arms	Active Comparator: Intradiscal Biacuplasty On the day of the procedure, patients were given midazolam for relaxation and, if needed, fentanyl IV during the procedure. For treatment subjects, two TransDiscal probes were positioned under fluoroscopic guidance in the posterior annulus of the intervertebral disc. The probes were attached to the Radiofrequency generator and Radiofrequency energy was delivered. Placement of the probes within the disc annulus was confirmed using oblique, lateral, and anterior-posterior fluoroscopic images. Following completion of procedure the patient was transferred to recovery and monitored for 45 minutes then discharged home with instructions. It was expected that the patient limit their activities during the first week after the procedure. Intervention: Device: The Transdiscal Radiofrequency Annuloplasty; Placebo Comparator: Sham Sham procedures mimicked active treatment procedures, except that the probes were positioned just outside of the disc and no radiofrequency energy was delivered through the electrodes. Thus, sham patients were provided similar tactile, auditory and visual experiences as treatment patients, without receiving the active RF treatment. Following completion of procedure the patient was transferred to recovery and monitored for 45 minutes then discharged home with instructions. It was expected that the patient limit their activities during the first week after the 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. Intervention: Device: The Transdiscal Radiofrequency Annuloplasty
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 20, 2012)	64
Original Estimated Enrollment ICMJE; (submitted: September 9, 2008)	8
Actual Study Completion Date	September 2012
Actual Primary Completion Date	September 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00750191
Other Study ID Numbers ICMJE	IRB 07-594; IRB 07-594
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Baylis Medical Company
Study Sponsor ICMJE	Baylis Medical Company
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Leonardo Kapural, MD Center for Clinical Research Principal Investigator: Bruce Vrooman, M.D. The Cleveland Clinic
PRS Account	Baylis Medical Company
Verification Date	November 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP