Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

N/ACompletedNCT05520463

Diskapi Teaching and Research Hospital60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sacroiliac Joint Arthritis Back Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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'

Time frame: 3 months

Secondary Outcomes

Performance time

Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed

Time frame: 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).

Time frame: 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

Time frame: At 3 months

Success rate

Proportions of reporting \>50% pain relief.

Time frame: 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

Time frame: 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;

Time frame: At 1 and 3 months

The number of needle passess

The number of attempts during the performance will be analysed.

Time frame: During the procedure

Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes