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Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750191
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
Baylis Medical Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lower Back Pain
Intervention Device: The Transdiscal Radiofrequency Annuloplasty
Enrollment 64
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Intradiscal Biacuplasty Sham
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 27 30
Completed 22 20
Not Completed 5 10
Arm/Group Title Intradiscal Biacuplasty Sham Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 27 30 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
30
 100.0%
57
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 30 participants 57 participants
40  (10) 39  (10) 39  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 30 participants 57 participants
Female
15
  55.6%
15
  50.0%
30
  52.6%
Male
12
  44.4%
15
  50.0%
27
  47.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 30 participants 57 participants
27 30 57
1.Primary Outcome
Title Physical Function
Hide Description

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).

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intradiscal Biacuplasty Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
62.04  (21.89) 48.67  (22.97)
2.Secondary Outcome
Title Pain
Hide Description Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intradiscal Biacuplasty Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.94  (2.15) 6.58  (2.11)
3.Secondary Outcome
Title Disability
Hide Description Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intradiscal Biacuplasty Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.94  (16.14) 41.17  (13.94)
4.Other Pre-specified Outcome
Title Opioid Usage
Hide Description Patient reported Opioid usage (converted to morphine equivalents)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intradiscal Biacuplasty Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: mg
36.87  (40.56) 49.48  (91.70)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intradiscal Biacuplasty Sham
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Intradiscal Biacuplasty Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Intradiscal Biacuplasty Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intradiscal Biacuplasty Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/30 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Leonard Kapural
Organization: The Center for Clinical Research
Phone: 1-336-765-6181
EMail: LKapural@ccrpain.com
Layout table for additonal information
Responsible Party: Baylis Medical Company
ClinicalTrials.gov Identifier: NCT00750191    
Other Study ID Numbers: IRB 07-594
IRB 07-594
First Submitted: September 9, 2008
First Posted: September 10, 2008
Results First Submitted: September 13, 2013
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014