Sacroiliac Joint PainNCT07749599
Comparison Between Traditional Bipolar Radiofrequency and Cooled Radiofrequency in Sacroiliac Joint Pain Patients
A study testing Traditional bipolar radiofrequency and Cooled radiofrequency in people with Sacroiliac Joint Pain, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- Traditional bipolar radiofrequency and Cooled radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assuit university hospitals
Asyut
Assuit university hospitals, 01113376317, Osamaabodeef14@gmail.com
About this study
Official title: Comparison Between Traditional Bipolar Radiofrequency and Cooled Radiofrequency in Sacroiliac Joint Pain Patients Prospective Randomized Controlled Clinical 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.
Read more
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
- Being tested
- Traditional bipolar radiofrequency, Cooled radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional bipolar radiofrequencyDevice
- 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 radiofrequencyDevice
- 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 group | Role | What they receive |
|---|---|---|
| Traditional bipolar radiofrequency group | Active comparator | Not described Receives: Device: Traditional bipolar radiofrequency |
| Cooled radiofrequency group | Active comparator | Not described Receives: Device: Cooled radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 6 months
Secondary outcomes (2)
•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.
Measured: 6 months
• 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Khaled Ahmed Abodeef, Assiut University
- Investigators
- Mohamed Abdelmonem Bakr, Principal investigator, department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.Rasha Ahmed Ali, Study director, department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.Mahmoud Bahaaeldin Mousa, Study director, department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.Osama Khaled Ahmed Abodeef, Study chair, department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749599
- Sponsor's protocol ID
- SIJ-RF-2026
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 2229976111. 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.
PubMed 188448539. 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.
PubMed 232533947. 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.
PubMed 22622915Dreyfuss 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.
PubMed 154736774. Nikolai Bogduk N. The innervation of the sacroiliac joint. Journal of Anatomy. 1992;180(Pt 2):273-280.
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.
PubMed 22994881Schwarzer 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.
PubMed 7709277Cohen 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.
PubMed 18648237
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Traditional Bipolar Radiofrequency and Cooled Radiofrequency in Sacroiliac Joint Pain Patients Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07749599
- Acronym / sponsor ID
- SIJ-RF-2026
- Conditions
- Sacroiliac Joint Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional bipolar radiofrequency group | Active comparator | Device: Traditional bipolar radiofrequency |
| Cooled radiofrequency group | Active comparator | Device: Cooled radiofrequency |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Coagulopathy or anticoagulant therapy not appropriately managed
- Local or systemic infection
- Pregnancy
- Severe psychiatric illness
- Previous radiofrequency ablation of the SI joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Traditional bipolar radiofrequency group |
| 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 | Device | Cooled radiofrequency group |
Primary outcome
• 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
2 secondary outcomes
•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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 22299761Patel 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.
- Background11. 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: PubMed 18844853Kapural 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.
- Background9. 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: PubMed 23253394Cohen 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.
- Background7. 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: PubMed 22622915Simopoulos 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.
- Background: PubMed 15473677Dreyfuss 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.
- Background4. Nikolai Bogduk N. The innervation of the sacroiliac joint. Journal of Anatomy. 1992;180(Pt 2):273-280.
- Background: PubMed 22994881Vleeming 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.
- Background: PubMed 7709277Schwarzer 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.
- Background: PubMed 18648237Cohen 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Abdelmonem Bakr principal investigator
department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.
Rasha Ahmed Ali study director
department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.
Mahmoud Bahaaeldin Mousa study director
department of anesthesiology and ICU and pain management, faculty of medicine, Assuit university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional bipolar radiofrequency and Cooled radiofrequency in people with Sacroiliac Joint Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama Khaled Ahmed Abodeef (01018089621, Osama.1423922@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Pain intensity measured by Visual Analog Scale (VAS) . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07749599, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.