Back to resultsEffectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound-guided S1 Radiofrequency stimulation
Fluoroscopic-guided S1 Radiofrequency stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria:
- Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
- Radicular pain in lumbar region for 3 months or more,
- Pattern of radiation suggestive for S1 pathology
Exclusion Criteria:
- Patient refusal
- Coagulopathy
- Uncooperative patients
- Malignant disorder or currently under treatment for a malignant disorder
- Pregnancy
- Leg pain due to localized hip or knee pathology
Sites / Locations
- Diskapi Yildirim Beyazit Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fluoroscopic-guided S1 Radiofrequency stimulation
Ultrasound-guided S1 Radiofrequency stimulation
Arm Description
Outcomes
Primary Outcome Measures
Pain scores
Visual analog scale (VAS) for pain at the follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
Secondary Outcome Measures
Oswestry Disability Index (ODI)
Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.
Patient satisfaction Questionnaire
Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Full Information
NCT ID
NCT05247892
First Posted
February 1, 2022
Last Updated
October 31, 2022
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05247892
Brief Title
Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
Official Title
Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency for the Management of Radicular Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoroscopic-guided S1 Radiofrequency stimulation
Arm Type
Active Comparator
Arm Title
Ultrasound-guided S1 Radiofrequency stimulation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided S1 Radiofrequency stimulation
Intervention Description
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopic-guided S1 Radiofrequency stimulation
Intervention Description
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance
Primary Outcome Measure Information:
Title
Pain scores
Description
Visual analog scale (VAS) for pain at the follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
Time Frame
baseline to 6 months post-procedure
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.
Time Frame
baseline to 6 months post-procedure
Title
Patient satisfaction Questionnaire
Description
Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Time Frame
baseline to 6 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
Radicular pain in lumbar region for 3 months or more,
Pattern of radiation suggestive for S1 pathology
Exclusion Criteria:
Patient refusal
Coagulopathy
Uncooperative patients
Malignant disorder or currently under treatment for a malignant disorder
Pregnancy
Leg pain due to localized hip or knee pathology
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
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