Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedNovember 2, 2022
October 1, 2022
8 months
February 1, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
baseline to 6 months post-procedure
Secondary Outcomes (2)
Oswestry Disability Index (ODI)
baseline to 6 months post-procedure
Patient satisfaction Questionnaire
baseline to 6 months post-procedure
Study Arms (2)
Fluoroscopic-guided S1 Radiofrequency stimulation
ACTIVE COMPARATORUltrasound-guided S1 Radiofrequency stimulation
EXPERIMENTALInterventions
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 1, 2022
First Posted
February 21, 2022
Study Start
February 1, 2022
Primary Completion
October 10, 2022
Study Completion
October 20, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10