Trial Outcomes & Findings for Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain (NCT NCT05409443)
NCT ID: NCT05409443
Last Updated: 2026-06-26
Results Overview
The number of participants with ≥50% change in their Numeric Pain Rating Scale (NPRS) pain score at the 3-month follow-up assessment. The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
3 month
Results posted on
2026-06-26
Participant Flow
Participant milestones
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Overall Study
Due to slow enrollment, the sponsor discontinued the study
|
8
|
12
|
Baseline Characteristics
Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain
Baseline characteristics by cohort
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=8 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=12 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 16.3 • n=20 Participants
|
63 years
STANDARD_DEVIATION 16.3 • n=20 Participants
|
63 years
STANDARD_DEVIATION 16.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=20 Participants
|
12 participants
n=20 Participants
|
20 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3 monthThe number of participants with ≥50% change in their Numeric Pain Rating Scale (NPRS) pain score at the 3-month follow-up assessment. The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=11 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Change in Numeric Pain Rating Score
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthThe number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale (NPRS) The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=11 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Percent of Relief Using the Numeric Pain Rating Scale
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=5 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=9 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Percent of Relief Using the Numeric Pain Rating Scale
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 18 monthThe percentage of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=4 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=5 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Percent of Relief Using the Numeric Pain Rating Scale
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 monthThe number of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthThe number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. * Each question has 6 statements, rated from 0 (no disability) to 5 (most severe disability). * The scores for all questions are added and then multiplied by two to obtain the index score, which ranges from 0 to 100. * A higher score on the ODI indicates a more severe disability caused by low back pain. Interpretation of ODI Scores: * 0% to 20%: Minimal disability. * 21% to 40%: Moderate disability. * 41% to 60%: Severe disability. * 61% to 80%: Crippled. * 81% to 100%: Severely disabled.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=11 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Oswestry Disability Index (ODI) Reduction
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthThe number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. * Each question has 6 statements, rated from 0 (no disability) to 5 (most severe disability). * The scores for all questions are added and then multiplied by two to obtain the index score, which ranges from 0 to 100. * A higher score on the ODI indicates a more severe disability caused by low back pain. Interpretation of ODI Scores: * 0% to 20%: Minimal disability. * 21% to 40%: Moderate disability. * 41% to 60%: Severe disability. * 61% to 80%: Crippled. * 81% to 100%: Severely disabled.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=10 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Oswestry Disability Index (ODI) Reduction
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. * Each question has 6 statements, rated from 0 (no disability) to 5 (most severe disability). * The scores for all questions are added and then multiplied by two to obtain the index score, which ranges from 0 to 100. * A higher score on the ODI indicates a more severe disability caused by low back pain. Interpretation of ODI Scores: * 0% to 20%: Minimal disability. * 21% to 40%: Moderate disability. * 41% to 60%: Severe disability. * 61% to 80%: Crippled. * 81% to 100%: Severely disabled.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=5 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=9 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Oswestry Disability Index (ODI) Reduction
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 monthThe number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. * Each question has 6 statements, rated from 0 (no disability) to 5 (most severe disability). * The scores for all questions are added and then multiplied by two to obtain the index score, which ranges from 0 to 100. * A higher score on the ODI indicates a more severe disability caused by low back pain. Interpretation of ODI Scores: * 0% to 20%: Minimal disability. * 21% to 40%: Moderate disability. * 41% to 60%: Severe disability. * 61% to 80%: Crippled. * 81% to 100%: Severely disabled.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=4 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=5 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Oswestry Disability Index (ODI) Reduction
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 monthThe number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. NOTE: The study ended before month 24 data could be gathered. * Each question has 6 statements, rated from 0 (no disability) to 5 (most severe disability). * The scores for all questions are added and then multiplied by two to obtain the index score, which ranges from 0 to 100. * A higher score on the ODI indicates a more severe disability caused by low back pain. Interpretation of ODI Scores: * 0% to 20%: Minimal disability. * 21% to 40%: Moderate disability. * 41% to 60%: Severe disability. * 61% to 80%: Crippled. * 81% to 100%: Severely disabled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthThe number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=11 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
EQ-5D Improvement
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthThe number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=8 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=10 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
EQ-5D Improvement
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=6 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=9 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
EQ-5D Improvement
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 18 monthThe number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=5 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=5 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
EQ-5D Improvement
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 monthThe proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthThe number of participants who report being "improved" or "much improved" on the PGIC scale
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=11 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Improvement
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthThe number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=8 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=10 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
PGIC Improvement
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=6 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=9 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
PGIC Improvement
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 18 monthThe number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=5 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=5 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
PGIC Improvement
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 monthThe proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 MonthsThe number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions: 1. How often do you have trouble falling asleep because of your back pain? 2. How often are you awakened by your back pain during the night? 3. How often are you awakened by your back pain in the morning? There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=11 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
The Pain and Sleep Questionnaire Three-item Index (PSQ-3)
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsThe number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions: 1. How often do you have trouble falling asleep because of your back pain? 2. How often are you awakened by your back pain during the night? 3. How often are you awakened by your back pain in the morning? There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=7 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=10 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
|
|---|---|---|
|
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsThe number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions: 1. How often do you have trouble falling asleep because of your back pain? 2. How often are you awakened by your back pain during the night? 3. How often are you awakened by your back pain in the morning? There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=5 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
|
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=9 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
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The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
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3 Participants
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7 Participants
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SECONDARY outcome
Timeframe: 18 MonthsThe number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions: 1. How often do you have trouble falling asleep because of your back pain? 2. How often are you awakened by your back pain during the night? 3. How often are you awakened by your back pain in the morning? There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep.
Outcome measures
| Measure |
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
n=4 Participants
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA): • Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2 and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm.
• The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation, the tines are retracted for all electrodes prior to removal.
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Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
n=5 Participants
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA): • To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process.
* A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18).
* The appropriate locations are confirmed in both AP and lateral views. Following injection of lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.
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|---|---|---|
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The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
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1 Participants
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4 Participants
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Adverse Events
Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place