Trial Outcomes & Findings for Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System (NCT NCT00802997)
NCT ID: NCT00802997
Last Updated: 2014-01-01
Results Overview
Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2014-01-01
Participant Flow
Participant milestones
| Measure |
Lateral Branch Neurotomy
The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment.
|
Sham Procedure
The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment.
|
|---|---|---|
|
Baseline to 3 Months
STARTED
|
34
|
17
|
|
Baseline to 3 Months
COMPLETED
|
34
|
17
|
|
Baseline to 3 Months
NOT COMPLETED
|
0
|
0
|
|
3 Months to 6 Months
STARTED
|
34
|
0
|
|
3 Months to 6 Months
COMPLETED
|
27
|
0
|
|
3 Months to 6 Months
NOT COMPLETED
|
7
|
0
|
|
6 Month to 9 Months
STARTED
|
27
|
0
|
|
6 Month to 9 Months
COMPLETED
|
25
|
0
|
|
6 Month to 9 Months
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
Baseline characteristics by cohort
| Measure |
Lateral Branch Neurotomy
n=34 Participants
|
Sham Procedure
n=17 Participants
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56 years
STANDARD_DEVIATION 15 • n=5 Participants
|
64 years
STANDARD_DEVIATION 14 • n=7 Participants
|
59 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
17 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Sacroiliac Joint Pain Intensity
|
6.1 Units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.8 Units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
6.0 Units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsScale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Outcome measures
| Measure |
Lateral Branch Neurotomy
n=34 Participants
|
Sham Procedure
n=17 Participants
|
|---|---|---|
|
Pain Status Change for Sacroiliac Joint Pain Intensity
|
-2.4 units on a scale
Standard Deviation 2.7
|
-0.8 units on a scale
Standard Deviation 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 MonthsScale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Outcome measures
| Measure |
Lateral Branch Neurotomy
n=27 Participants
|
Sham Procedure
|
|---|---|---|
|
Pain Status Change for Sacroiliac Joint Pain Intensity
|
-2.5 units on a scale
Standard Deviation 2.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 9 MonthsScale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Outcome measures
| Measure |
Lateral Branch Neurotomy
n=25 Participants
|
Sham Procedure
|
|---|---|---|
|
Pain Status Change for Sacroiliac Joint Pain Intensity
|
-2.7 units on a scale
Standard Deviation 2.7
|
—
|
Adverse Events
Lateral Branch Neurotomy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Meghal Khakhar, Director of Regulatory and Scientific Affairs
Baylis Medical
Phone: 9056024875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results communications must be provided to the Sponsor for review 30 days prior to public release. The Sponsor has the right to review materials for the purposes of preserving confidentiality of Sponsor's proprietary information, which may be removed at the Sponsor's request, and for identification of patentable inventions. The Investigator has no obligation to address any additional comments provided during the review and has final control and approval of publication content.
- Publication restrictions are in place
Restriction type: OTHER