Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Study Overview
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Brief Summary
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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.

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

Conditions
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Sacroiliac Joint Arthritis, Back Pain

Intervention / Treatment
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* Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance
* Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |