Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

NCT05520463 | Completed

• 1 other identifier: 127/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Arthritis; Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Performance time

  During the procedure

• Patient satisfaction

  At 3 months

• Pain medication use

  At 3 months

• Success rate

  At 3 months

• Functional disability

  At 1 and 3 months

Study Arms (2)

Ultrasound guided sacral lateral branch radiofrequency ablation

EXPERIMENTAL

Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.

Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance

Fluoroscopy guided sacral lateral branch radiofrequency ablation

ACTIVE COMPARATOR

Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.

Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

Interventions

Sacral lateral branch radiofrequency ablation under ultrasound guidance PROCEDURE

Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.

Ultrasound guided sacral lateral branch radiofrequency ablation

Sacral lateral branch radiofrequency ablation under fluoroscopy guidance PROCEDURE

Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

Fluoroscopy guided sacral lateral branch radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28178092 BACKGROUND

• 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.

  PMID: 25247902 BACKGROUND

MeSH Terms

Conditions

Sacroiliitis; Back Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: September 1, 2022
• Primary Completion: June 25, 2023
• Study Completion: July 5, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)