Comparison Between Traditional Bipolar Radiofrequency and Cooled Radiofrequency in Sacroiliac Joint Pain Patients

Official title

Comparison Between Traditional Bipolar Radiofrequency and Cooled Radiofrequency in Sacroiliac Joint Pain Patients Prospective Randomized Controlled Clinical Trial

Overview

Sacroiliac joint pain is contributor to chronic low back pain, accounting for 15-30% of cases. It is a synovial and syndesmotic articulation plays a role in load transfer between spine and lower extremities. Its limited mobility, strong ligaments makes it susceptible to pain generation in cases of inflammation and degeneration. The innervation of the SIJ is derived from the dorsal sacral rami (S1-S3), with contributions from L4-L5 dorsal rami. This explains the variability in pain distribution. Patients present with low back pain that may radiate to buttock, groin, or posterior thigh. The diagnosis of SIJ pain relies on diagnostic blocks. At least 70-75% pain relief following intra-articular injection . However, diagnostic blocks have limitations, including false-positive rates and variability in technique . Management for SIJ pain include conservative, interventional, and surgical approaches. Conservative treatment consists of physical therapy, NSAIDs, and activity modification.While a significant proportion progress to interventional therapies due to persistent pain . RFA is as an effective minimally invasive treatment. Monopolar RFA was initially used; however, its efficacy was limited by small lesion size and anatomical variability . Bipolar radiofrequency were developed, allowing the creation of larger and continuous lesions. This has been associated with improved outcomes . Cooled radiofrequency represents an advancement in RFA . By internally cooling the electrode, CRF prevents tissue charring allowing for greater energy delivery, resulting larger lesions. Randomized controlled trials demonstrated that CRF provides significant pain relief at 6 and 12 months .

Interventions

• Device Traditional bipolar radiofrequency
  * Procedure performed under fluoroscopic guidance * Bipolar RF cannulae placed along the lateral branches innervating the SI joint * RF lesioning at 80°C for 90 seconds * Multiple lesions created to cover target nerves
• Device Cooled radiofrequency
  * Procedure performed under fluoroscopic guidance * Cooled RF probes placed at identical anatomical landmarks * Lesioning performed according to manufacturer protocol * Target tissue temperature maintained below 45°C

Primary outcome measures

• • Pain intensity measured by Visual Analog Scale (VAS) . [Time frame: 6 months]

Secondary outcome measures (2)

• •Functional disability using Oswestry Disability Index (ODI) [Time frame: 6 months]
• • Quality of life using 36 item short form health survey (SF-36) questionnaire [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Age between 18-70 years
• Chronic sacroiliac joint pain for ≥ 3 months
• Pain intensity ≥ 5 on the Visual Analog Scale (VAS)
• Positive SI joint provocative tests (at least 3 out of 5)
• ≥ 50% pain relief following diagnostic SI joint block
• Failure of conservative treatment for at least 6 weeks

Exclusion criteria

• Coagulopathy or anticoagulant therapy not appropriately managed
• Local or systemic infection
• Pregnancy
• Severe psychiatric illness
• Previous radiofrequency ablation of the SI joint
• Spinal pathology explaining pain other than SI joint dysfunction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Egypt · 1 center

• Assuit university hospitals — Asyut

Publications

• Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2. PMID 22299761
• 11. Ho KY, Hadi MA, Pasutharnchat K, Tan KH. Cooled radiofrequency denervation for sacroiliac joint pain: a retrospective study. Regional Anesthesia and Pain Medicine. 2013;38(6):506-510.
• Kapural L, Nageeb F, Kapural M, Cata JP, Narouze S, Mekhail N. Cooled radiofrequency system for the treatment of chronic pain from sacroiliitis: the first case-series. Pain Pract. 2008 Sep-Oct;8(5):348-54. doi: 10.1111/j.1533-2500.2008.00231.x. PMID 18844853
• 9. Burnham RS, Yasui Y. An alternative method of radiofrequency neurotomy of the sacroiliac joint: a pilot study of the effectiveness of lateral branch ablation. Archives of Physical Medicine and Rehabilitation. 2007;88(2):150-155.
• Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148. PMID 23253394
• 7. Laxmaiah Manchikanti L, Pampati V, Fellows B, Bakhit CE. The diagnostic validity and therapeutic value of sacroiliac joint injections. Pain Physician. 2000;3(3):285-296.
• Simopoulos TT, Manchikanti L, Singh V, Gupta S, Hameed H, Diwan S, Cohen SP. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012 May-Jun;15(3):E305-44. PMID 22622915
• Dreyfuss P, Dreyer SJ, Cole A, Mayo K. Sacroiliac joint pain. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):255-65. doi: 10.5435/00124635-200407000-00006. PMID 15473677

Identifiers

NCT: NCT07749599 · SIJ-RF-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗