Clinical trial NCT05944861: Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections
Official title: Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sacroiliac Joint Somatic Dysfunction
Sacroiliac Joint Pain
Keywords: Sacroiliac joint pain
Sacroiliac joint injection
Ultrasonography guided injection
Flouroscopy guided injection
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided technique. Secondary objectives are to evaluate the effectiveness of the treatment with both methods and to record the adverse events that may be encountered during the procedure.

Detailed description: The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure. Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.

Eligibility 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)

Primary outcomes:
measure: Processing Time
timeFrame: during the intervention
Secondary outcomes:
measure: Fluoroscopy Time
timeFrame: during the intervention
measure: Kerma-area Product (μGy)
timeFrame: during the intervention
measure: Visual Analogue Scale
timeFrame: baseline, change from baseline VAS at 1 month after intervention
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: baseline, change from baseline VAS at 1 month after intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
state: Cankaya
Study officials:
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Serdar KESIKBURUN, MD
role: PRINCIPAL_INVESTIGATOR
References: