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

NCT07749599 | Not Yet Recruiting DMC

• 1 other identifier: SIJ-RF-2026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Sacroiliac Joint Pain

Outcome Measures

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

  6 months

Secondary Outcomes (2)

• •Functional disability using Oswestry Disability Index (ODI)

  6 months

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

  6 months

Study Arms (2)

Traditional bipolar radiofrequency group

ACTIVE COMPARATOR

Device: Traditional bipolar radiofrequency

Cooled radiofrequency group

ACTIVE COMPARATOR

Device: Cooled radiofrequency

Interventions

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

Traditional bipolar radiofrequency group

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

Cooled radiofrequency group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospitals

Asyut, Egypt

Location

Related Publications (12)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 4. Nikolai Bogduk N. The innervation of the sacroiliac joint. Journal of Anatomy. 1992;180(Pt 2):273-280.

  BACKGROUND

• Vleeming A, Schuenke MD, Masi AT, Carreiro JE, Danneels L, Willard FH. The sacroiliac joint: an overview of its anatomy, function and potential clinical implications. J Anat. 2012 Dec;221(6):537-67. doi: 10.1111/j.1469-7580.2012.01564.x. Epub 2012 Sep 19.

  PMID: 22994881 BACKGROUND

• Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine (Phila Pa 1976). 1995 Jan 1;20(1):31-7. doi: 10.1097/00007632-199501000-00007.

  PMID: 7709277 BACKGROUND

• Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.

  PMID: 18648237 BACKGROUND

Study Officials

• Mohamed Abdelmonem Bakr

  department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.

  PRINCIPAL INVESTIGATOR

• Rasha Ahmed Ali

  department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.

  STUDY DIRECTOR

• Mahmoud Bahaaeldin Mousa

  department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.

  STUDY DIRECTOR

• Osama Khaled Ahmed Abodeef

  department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.

  STUDY CHAIR

Central Study Contacts

Osama Khaled Ahmed Abodeef

CONTACT

01018089621; Osama.1423922@aun.edu.eg

Rasha Ahmed Ali

CONTACT

01000440773; rashaahmed11@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Osama Khaled Ahmed Abodeef

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)