Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520463
• Other study ID #: 127/23
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: July 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 5, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Sacroiliac Joint Arthritis
• Sacroiliitis

Intervention

Procedure:
• Sacral lateral branch radiofrequency ablation under ultrasound guidance
Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.
• Sacral lateral branch radiofrequency ablation under fluoroscopy guidance
Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

Locations

Country	Name	City	State
Turkey	Health Science University Diskapi Yildirim Beyazit Training and Research Hospital	Yenimahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Success rate	Proportions of reporting >50% pain relief.	At 3 months
Secondary	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
Secondary	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
Secondary	The number of needle passess	The number of attempts during the performance will be analysed.	During the procedure