Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Sacroiliac Joint Arthritis
• Intervention / Treatment: Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance; Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Yenimahalle, Ankara, Turkey, 06170
      • Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound guided sacral lateral branch radiofrequency ablation; Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.	Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance; Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.
Active Comparator: Fluoroscopy guided sacral lateral branch radiofrequency ablation; Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.	Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance; Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain numerical rating score from baseline	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'	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance time	Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed	During the procedure
Patient satisfaction	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).	At 3 months
Pain medication use	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	At 3 months
Success rate	Proportions of reporting >50% pain relief.	At 3 months
Functional disability	Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible	At 1 and 3 months
Quality of life ( SF-36)	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;	At 1 and 3 months
The number of needle passess	The number of attempts during the performance will be analysed.	During the procedure

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Publications and helpful links

General Publications

• Finlayson RJ, Etheridge JB, Elgueta MF, Thonnagith A, De Villiers F, Nelems B, Tran DQ. A Randomized Comparison Between Ultrasound- and Fluoroscopy-Guided Sacral Lateral Branch Blocks. Reg Anesth Pain Med. 2017 May/Jun;42(3):400-406. doi: 10.1097/AAP.0000000000000569.
• Cox RC, Fortin JD. The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. Pain Physician. 2014 Sep-Oct;17(5):459-64.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis
• Other Study ID Numbers: 127/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Findings of this study will be available from the principle investigator upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No