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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssiut University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Coagulopathy or anticoagulant therapy not appropriately managed

Local or systemic infection

Pregnancy

Severe psychiatric illness

Trial design

Design model

Parallel

Treatments tested in this trial

  • Traditional bipolar radiofrequency

    Device

    * 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

    Device

    * 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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Traditional bipolar radiofrequency groupActive comparator 1 intervention
Group B: Cooled radiofrequency groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

• Pain intensity measured by Visual Analog Scale (VAS) .

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

Time frame
6 months

Secondary outcomes

1

•Functional disability using Oswestry Disability Index (ODI)

Interpretation of scores 0% to 20%: minimal disability The patient can cope with most living activities. Usually no treatment is indicated. 21%-40%: moderate disability The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult, and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected, and the patient can usually be managed by conservative means. 41%-60%: severe disability Pain remains the main problem in this group, but activities of daily living are affected, These patients require a detailed investigation. 61%-80%: crippled Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100% These patients are either bed-bound or exaggerating their symptoms.

Time frame
6 months
2

• Quality of life using 36 item short form health survey (SF-36) questionnaire

The 8 Health Domains: * Physical Functioning: Limitations in physical activities due to health problems. * Role-Physical: Limitations in usual role activities because of physical health problems. * Role-Emotional: Limitations in usual role activities because of emotional problems. * Social Functioning: Limitations in social activities due to physical or emotional problems. * Bodily Pain: Severity and interference of pain with normal work. * Mental Health: General feelings of being nervous, downhearted, or peaceful. * Vitality: Levels of energy and fatigue. * General Health: Overall perceptions and ratings of personal health. Scoring: Each domain is scored on a scale from 0 to 100, where 0 represents maximum disability or poor health, and 100 represents no disability or optimal health.

Time frame
6 months

Other outcomes

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