Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure. A Randomised ControlledTrial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Processing Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Combined ultrasonography and flouroscopy guided injeciton
In 19 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy.
Intervention: Combined ultrasonography and flouroscopy guided injeciton (Other)
Flouroscopy guided injection
In 19 patients selected after randomization, the procedure will be performed only through fluoroscopy.
Intervention: Flouroscopy guided injection (Other)
Outcomes
Primary Outcomes
Processing Time
Time Frame: during the intervention
The processing time will be measured by the other researcher in the processing room with the help of a stopwatch. The stopwatch will be started when the needle touches the patient and will be stopped when the procedure is finished. It will be recorded in seconds
Secondary Outcomes
- Fluoroscopy Time(during the intervention)
- Visual Analogue Scale(baseline, change from baseline VAS at 1 month after intervention)
- Oswestry Low Back Pain Disability Questionnaire(baseline, change from baseline VAS at 1 month after intervention)
- Kerma-area Product (μGy)(during the intervention)
Investigators
Yasin Demir
Associate professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital