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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study summary

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 .

Eligibility

Primary outcome measure(s)

• • Pain intensity measured by Visual Analog Scale (VAS) . — 6 months
  A Visual Analog Scale (VAS) is a psychometric instrument used to measure subjective experiences that cannot be directly quantified (like pain severity, fatigue, or mood). It typically features a 10cm or 100mm horizontal or vertical line with descriptive anchors at each extreme, and respondents indicate their level of feeling by making a mark on the line. Score Interpretation (e.g., for Pain): 0 to 4 mm: No pain 5 to 44 mm: Mild pain 45 to 74 mm: Moderate pain 75 to 100 mm: Severe pain

Trial sites (1)

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