Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Not Applicable

Completed

• Conditions: Sacroiliac Joint Arthritis; Back Pain
• Interventions: Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance; Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

• Registration Number: NCT05520463
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-30
• Study Start: 2022-09-01
• Primary Completion: 2023-06-25
• Status Verified: 2023-07
• Study Completion: 2023-07-05
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.

  • 50% pain relief after prognostic sacral lateral branch block

• At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test]

• Refractory to conservative therapy

Exclusion Criteria

The exclusion criteria were;

• Uncontrolled psychiatric or neurological illness
• Sacroiliac joint pain due to other disorders,
• Lumbar radiculopathy
• Rheumatological diseases
• Systemic active infections
• Malignancies, previous surgery on the affected sacroiliac joint,
• History of traumatic hip injury,
• History of bleeding disorders,
• Platelet values < 150.000 / µl,
• Sacroiliac joint injection within the preceding 3 months,
• Allergy to local anesthetics and steroids,
• Pregnancy, inability to concent, Implanted pacemaker or defibrilator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided sacral lateral branch radiofrequency ablation	Sacral lateral branch radiofrequency ablation under ultrasound guidance	Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.
Fluoroscopy guided sacral lateral branch radiofrequency ablation	Sacral lateral branch radiofrequency ablation under fluoroscopy guidance	Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.

Primary Outcome Measures

Name	Time	Method
Change in pain numerical rating score from baseline	3 months	The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable'

Secondary Outcome Measures

Name	Time	Method
Performance time	During the procedure	Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed
Patient satisfaction	At 3 months	Changes in overall satisfaction will be assessed using a 5-point Likert scale. (1, very dissatisfied; 2, dissatisfied; 3, neutral; 4, satisfied; 5, very satisfied).
Pain medication use	At 3 months	Mean change in analgesic consumption is assessed using QAQ, a tool designed to record patient-reported pain medication use. The higher score indicates higher pain medication use
Success rate	At 3 months	Proportions of reporting \>50% pain relief.
Functional disability	At 1 and 3 months	Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible
Quality of life ( SF-36)	At 1 and 3 months	Quality of life (QoL) will assessed via SF-36, which consists of 36 items ad 2 summary values for Physical Component Summary ( PSC) and Mental Component Summary (MSC). Subscale scores range from 0 to 100, with 100 being the most positive QoL in that area and 0 the lowest;
The number of needle passess	During the procedure	The number of attempts during the performance will be analysed.

Trial Locations

Locations (1)

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital; 🇹🇷 Yenimahalle, Ankara, Turkey