Clinical trial NCT05520463: Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation
Official title: A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Arthritis
Back Pain
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain numerical rating score from baseline
timeFrame: 3 months
Secondary outcomes:
measure: Performance time
timeFrame: During the procedure
measure: Patient satisfaction
timeFrame: At 3 months
measure: Pain medication use
timeFrame: At 3 months
measure: Success rate
timeFrame: At 3 months
measure: Functional disability
timeFrame: At 1 and 3 months
measure: Quality of life ( SF-36)
timeFrame: At 1 and 3 months
measure: The number of needle passess
timeFrame: During the procedure
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
state: Ankara
Study officials:
References:
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.
citation: 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.