Sacroiliac Joint ArthritisNCT05520463
Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation
A study testing Sacral lateral branch radiofrequency ablation under ultrasound guidance and Sacral lateral branch radiofrequency ablation under fluoroscopy guidance in people with Sacroiliac Joint Arthritis and Back Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Arthritis, Back Pain
- What is being tested?
- Sacral lateral branch radiofrequency ablation under ultrasound guidance and Sacral lateral branch radiofrequency ablation under fluoroscopy guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.
- 50% pain relief after prognostic sacral lateral branch block
- At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test]
- Refractory to conservative therapy
Who cannot join
- Uncontrolled psychiatric or neurological illness
- Sacroiliac joint pain due to other disorders,
- Lumbar radiculopathy
- Rheumatological diseases
- Systemic active infections
- Malignancies, previous surgery on the affected sacroiliac joint,
Show all 12Show fewer
- History of traumatic hip injury,
- History of bleeding disorders,
- Platelet values < 150.000 / µl,
- Sacroiliac joint injection within the preceding 3 months,
- Allergy to local anesthetics and steroids,
- Pregnancy, inability to concent, Implanted pacemaker or defibrilator.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation
Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.
- Conditions
- Sacroiliac Joint Arthritis, Back Pain
- Being tested
- Sacral lateral branch radiofrequency ablation under ultrasound guidance, Sacral lateral branch radiofrequency ablation under fluoroscopy guidance
- Medical subject headings
- Sacroiliitis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral lateral branch radiofrequency ablation under ultrasound guidanceProcedure or surgery
Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.
Sacral lateral branch radiofrequency ablation under fluoroscopy guidanceProcedure or surgery
Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided sacral lateral branch radiofrequency ablation | Experimental | Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance. Receives: Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidance |
| Fluoroscopy guided sacral lateral branch radiofrequency ablation | Active comparator | Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance. Receives: Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain numerical rating score from baseline
The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable'
Measured: 3 months
Secondary outcomes (7)
Performance time
Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed
Measured: During the procedure
Patient satisfaction
Changes in overall satisfaction will be assessed using a 5-point Likert scale. (1, very dissatisfied; 2, dissatisfied; 3, neutral; 4, satisfied; 5, very satisfied).
Measured: At 3 months
Pain medication use
Mean change in analgesic consumption is assessed using QAQ, a tool designed to record patient-reported pain medication use. The higher score indicates higher pain medication use
Measured: At 3 months
Success rate
Proportions of reporting >50% pain relief.
Measured: At 3 months
Functional disability
Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible
Measured: At 1 and 3 months
Quality of life ( SF-36)
Quality of life (QoL) will assessed via SF-36, which consists of 36 items ad 2 summary values for Physical Component Summary ( PSC) and Mental Component Summary (MSC). Subscale scores range from 0 to 100, with 100 being the most positive QoL in that area and 0 the lowest;
Measured: At 1 and 3 months
The number of needle passess
The number of attempts during the performance will be analysed.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2022
- Primary completion25 Jun 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint ArthritisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Cihan Kose, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520463
- Sponsor's protocol ID
- 127/23
- Status last verified
- Jul 2023
- First submitted
- 24 Aug 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Findings of this study will be available from the principle investigator upon reasonable request.
Publications
Finlayson RJ, Etheridge JB, Elgueta MF, Thonnagith A, De Villiers F, Nelems B, Tran DQ. A Randomized Comparison Between Ultrasound- and Fluoroscopy-Guided Sacral Lateral Branch Blocks. Reg Anesth Pain Med. 2017 May/Jun;42(3):400-406. doi: 10.1097/AAP.0000000000000569.
PubMed 28178092Cox RC, Fortin JD. The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. Pain Physician. 2014 Sep-Oct;17(5):459-64.
PubMed 25247902
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT05520463
- Acronym / sponsor ID
- 127/23
- Conditions
- Sacroiliac Joint Arthritis, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 30 Aug 2022 (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 is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided sacral lateral branch radiofrequency ablation | Experimental | Procedure: Sacral lateral branch radiofrequency ablation under ultrasound guidancePatients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance. |
| Fluoroscopy guided sacral lateral branch radiofrequency ablation | Active comparator | Procedure: Sacral lateral branch radiofrequency ablation under fluoroscopy guidancePatients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.
- At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test]
- Refractory to conservative therapy
Key exclusion criteria (12 listed)
- Uncontrolled psychiatric or neurological illness
- Sacroiliac joint pain due to other disorders,
- Lumbar radiculopathy
- Rheumatological diseases
- Systemic active infections
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 |
|---|---|---|
| Sacral lateral branch radiofrequency ablation under ultrasound guidanceSacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach. | Procedure or surgery | Ultrasound guided sacral lateral branch radiofrequency ablation |
| Sacral lateral branch radiofrequency ablation under fluoroscopy guidanceSacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach. | Procedure or surgery | Fluoroscopy guided sacral lateral branch radiofrequency ablation |
Primary outcome
Change in pain numerical rating score from baseline
Time frame: 3 months
The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable'
7 secondary outcomes
Performance time
Time frame: During the procedure
Patient satisfaction
Time frame: At 3 months
Pain medication use
Time frame: At 3 months
Success rate
Time frame: At 3 months
Functional disability
Time frame: At 1 and 3 months
Quality of life ( SF-36)
Time frame: At 1 and 3 months
The number of needle passess
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 28178092Finlayson RJ, Etheridge JB, Elgueta MF, Thonnagith A, De Villiers F, Nelems B, Tran DQ. A Randomized Comparison Between Ultrasound- and Fluoroscopy-Guided Sacral Lateral Branch Blocks. Reg Anesth Pain Med. 2017 May/Jun;42(3):400-406. doi: 10.1097/AAP.0000000000000569.
- Background: PubMed 25247902Cox RC, Fortin JD. The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. Pain Physician. 2014 Sep-Oct;17(5):459-64.
- Individual participant dataSharing planned: No. Findings of this study will be available from the principle investigator upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral lateral branch radiofrequency ablation under ultrasound guidance and Sacral lateral branch radiofrequency ablation under fluoroscopy guidance in people with Sacroiliac Joint Arthritis and Back Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 7 Jul 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain numerical rating score from baseline (time frame: 3 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 NCT05520463, which also lists 2 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 7 Jul 2023.