Using ultrasound and fluoroscopy for sacroiliac joint injections
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure
NA · Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · NCT05944861
This study tests if using both ultrasound and X-ray guidance for sacroiliac joint injections is safer and more effective for people with chronic low back or gluteal pain compared to using X-ray alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Ankara, Cankaya) |
| Trial ID | NCT05944861 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of sacroiliac joint injections guided by a combination of ultrasonography and fluoroscopy compared to fluoroscopy alone. Patients with chronic low back or gluteal pain will be randomized into two groups to assess the duration of the procedure and radiation exposure. The study will also evaluate treatment effectiveness and record any adverse events during the injections. Key metrics include fluoroscopy time and radiation dose, along with patient-reported pain and disability scores.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing chronic low back or gluteal pain without radicular symptoms, unresponsive to conservative treatments.
Not a fit: Patients with conditions such as malignancy, osteoporosis, or those who have had spinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective pain management for patients with sacroiliac joint dysfunction.
How similar studies have performed: While similar studies have explored fluoroscopy-guided injections, the combination with ultrasonography is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months * Pain score greater than 3 according to NRS * Unresponsiveness to conservative treatment (such as exercise, NSAID) * At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive Exclusion Criteria: Refusing to participate in the study * Pregnancy * Infective sacroiliitis * Malignancy * Osteoporosis * Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.) * Neurological finding in the lower extremity * Pain spreading below the knee * History of spinal surgery * History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Where this trial is running
Ankara, Cankaya
- SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital — Ankara, Cankaya, Turkey (RECRUITING)
Study contacts
- Principal investigator: Serdar KESIKBURUN, MD — SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Study coordinator: Serdar KESIKBURUN, MD
- Email: serdarkb@gmail.com
- Phone: +903122911402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sacroiliac Joint Somatic Dysfunction, Sacroiliac Joint Pain, Sacroiliac joint pain, Sacroiliac joint injection, Ultrasonography guided injection, Flouroscopy guided injection