Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylis Medical Company
ClinicalTrials.gov Identifier:
NCT00750191
First received: September 9, 2008
Last updated: November 20, 2013
Last verified: November 2013
Results First Received: September 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Lower Back Pain
Intervention: Device: The Transdiscal Radiofrequency Annuloplasty

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among the 32 treatment subjects, 4 were removed from the study due to violation of eligibility criteria and 1 removed for withdrawing patient consent. Among the 32 sham subjects, 2 patients were removed from the study due to violation of eligibility criteria.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Intradiscal Biacuplasty     Sham  
STARTED     27     30  
COMPLETED     22     20  
NOT COMPLETED     5     10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
    Intradiscal Biacuplasty     Sham     Total  
Number of Participants  
[units: participants]
  27     30     57  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     30     57  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 10     39  ± 10     39  ± 10  
Gender  
[units: participants]
     
Female     15     15     30  
Male     12     15     27  
Region of Enrollment  
[units: participants]
     
United States     27     30     57  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Physical Function   [ Time Frame: 6 months ]

2.  Secondary:   Pain   [ Time Frame: 6 months ]

3.  Secondary:   Disability   [ Time Frame: 6 months ]

4.  Other Pre-specified:   Opioid Usage   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
none


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Leonard Kapural
Organization: The Center for Clinical Research
phone: 1-336-765-6181
e-mail: LKapural@ccrpain.com


No publications provided by Baylis Medical Company

Publications automatically indexed to this study:

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
Results First Received: September 13, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board