Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
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ClinicalTrials.gov Identifier: NCT00750191 |
Recruitment Status
:
Completed
First Posted
: September 10, 2008
Results First Posted
: January 8, 2014
Last Update Posted
: January 8, 2014
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Tracking Information | |||||||
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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 |
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). |
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE |
Opioid Usage [ Time Frame: 6 months ] Patient reported Opioid usage (converted to morphine equivalents)
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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 |
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Condition ICMJE | Lower Back Pain | ||||||
Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
64 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |
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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 |