Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections
- Conditions
- Sacroiliac Joint Somatic DysfunctionSacroiliac Joint Pain
- Interventions
- Other: Flouroscopy guided injectionOther: Combined ultrasonography and flouroscopy guided injeciton
- Registration Number
- NCT05944861
- Lead Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
- 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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flouroscopy guided injection Flouroscopy guided injection In 17 patients selected after randomization, the procedure will be performed only through fluoroscopy. Combined ultrasonography and flouroscopy guided injeciton Combined ultrasonography and flouroscopy guided injeciton In 17 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy.
- Primary Outcome Measures
Name Time Method Processing Time 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 Outcome Measures
Name Time Method Fluoroscopy Time during the intervention The fluoroscopy time applied to the patient is automatically measured by the fluoroscopy device. This data will be saved
Visual Analogue Scale baseline, change from baseline VAS at 1 month after intervention Severity of pain was assessed using the standard 10 point VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Oswestry Low Back Pain Disability Questionnaire baseline, change from baseline VAS at 1 month after intervention The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.
Kerma-area Product (μGy) during the intervention The kerma area product will be measured to measure the radiation level to which the patient is exposed. This data is automatically measured by the fluoroscopy device.
Trial Locations
- Locations (1)
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
🇹🇷Ankara, Cankaya, Turkey