Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

NCT ID: NCT05520463

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sacroiliac Joint Arthritis Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultrasound guided sacral lateral branch radiofrequency ablation

Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.

Group Type EXPERIMENTAL

Sacral lateral branch radiofrequency ablation under ultrasound guidance

Intervention Type PROCEDURE

Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.

Fluoroscopy guided sacral lateral branch radiofrequency ablation

Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.

Group Type ACTIVE_COMPARATOR

Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

Intervention Type PROCEDURE

Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sacral lateral branch radiofrequency ablation under ultrasound guidance

Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.

Intervention Type PROCEDURE

Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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,
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Halil Cihan Kose

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28178092 (View on PubMed)

Cox 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.

Reference Type BACKGROUND
PMID: 25247902 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

127/23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.