Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07749599

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

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 .

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sacroiliac Joint Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. •Functional disability using Oswestry Disability Index (ODI)

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Osama Khaled Ahmed Abodeef

CONTACT

[email protected]

01018089621

Rasha Ahmed Ali

CONTACT

[email protected]

01000440773

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.