]>
IRCT20170314033069N4 IRCT 2021-01-13 Vice President of Research Guilan university of medical sciences Comparison of ultrasound and fluoroscopic guided intra-articular sacroiliac injection in patients with sacroiliac joint disorder Comparing the effectiveness of ultrasound-guided versus fluoroscopy-guided sacroiliac joint intra-articular injection in patients with sacroiliac joint disorders 2021-01-20 anticipated 122 Complete https://irct.ir/trial/53075 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals will be grouped by block randomization. First, 4 blocks will be prepared as follows: AABB, ABAB, ABBA, BBAA, BABA, BAAB These blocks are then randomly selected and individuals will be divided into two groups according to A and B: ultrasound and fluoroscopy. This will be repeated continuously, Blinding description: This study is single-blinded ,patients and the physician performing the work are aware of the treatment for each patient and the evaluator is unaware. 2 Chronic pain of sacroiliac joint. Intervention 1: Intervention group Sacroiliac joint injection with ultrasound guide: patients will be positioned prone with a pillow under their abdomen. A low-frequency curved transducer (4 to 6 megahertz) perpendicular to the skin on the external sacrum will be placed in the midline with a cross-sectional view to detect the sacral hiatus. The probe will be moved laterally until the lateral edge of the sacrum is visible, then moved toward the caudal to find the inner direction of the iliac bone. At this location, the sacroiliac joint appears as a wedge-shaped hypoechoic structure. The suitable place for injection is at the level of the second sacral foramen, which is approximately 2-3 centimeters above the caudal surface of the sacroiliac joint. lidocaine1% (manufacturer: Caspian tamin Company. made in Iran) will be injected subcutaneously into the inner edge of the probe. A needle with a 22 gauge in-plane and oblique and anterior position will be inserted into the joint. After the needle is inserted deep into the iliac bone, it is no longer visible with an ultrasound. The popping sound is felt when the synovial joint ruptures. Intervention 2: Intervention group Sacroiliac joint injection with fluoroscopic guide: Initially, standard monitoring will be performed throughout the procedure. The patient will be positioned in the prone with the head turned to one side. A pillow is placed under the abdomen to bend the waist. Under the direct anterior-posterior view, the sacroiliac joint shows several lines that point toward the craniocerebral cortex in a semi-parallel pattern. The lateral line shows the ventral or anterior margin of the joint, and the inner line represents the dorsal or posterior margin of the joint. For a better view of the lower areas of the upper posterior iliac and iliac crest, the C-arm is initially rotated 30 degrees from the caudal to the axial plate. The C-arm is angled, usually between 5 and 20 degrees in the opposite direction, until the space of the lower joint is clearly defined. The target area is located along the lower posterior part of the joint 1 to 2 centimeters towards the cephalad from the most caudal point. The target area will be prepared and draped with the usual sterile method. The skin is anesthetized with 1 to 2 cc of lidocaine 1% through needle number 25. Spinal needle Number 22 travels coaxially to the lower bridge of the sacroiliac joint and will be confirmed by giving alternating images at regular intervals (every 2 to 4 millimeters of the needle advance). When the posterior surface of the sacroiliac joint is contacted, the needle goes to the point where it ruptures the joint capsule. Resistance changes will be commonly felt as the needle passes through the capsular tissue, and the tip of the needle usually deflects slightly when it strikes the surface of the ilium. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not decided yet
public Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Rasht University of Medical Sciences scientific Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients over 18 years old who have been nominated for sacroiliac joint injection due to persistent sacroiliac joint pain Out of 7 tests in clinical examinations, at least 4 examinations are positive The patient's average pain over the past week is at least 3 out of 10 (in Numerical Rating scale) The patient has persistent pain for at least 6 weeks and does not respond to at least one or two conservative treatments such as oral medications, anti-inflammatory drugs, analgesics, muscle relaxants, and physical therapies. 18 years no limit Both Complaints of lower back pain so that the distinction between sacroiliac joint and L5 / S1 fastogenic back pain is indistinguishable. Dye contrast sensitivity Contraindications to fluoroscopy Active lesion in structures of sacroiliac joint such as lumbar spine pathologies and hip pathology Secondary orthopathy to rheumatoid causes Abnormal anatomy Infection, bleeding and trauma at the site Previous history of intro-articular injection Active inflammatory diseases Untreated coagulopathies M46.98 Unspecified inflammatory spondylopathy, sacral and sacrococcygeal region Treatment - Devices Treatment - Devices Intervention group Sacroiliac joint injection with ultrasound guide: patients will be positioned prone with a pillow under their abdomen. A low-frequency curved transducer (4 to 6 megahertz) perpendicular to the skin on the external sacrum will be placed in the midline with a cross-sectional view to detect the sacral hiatus. The probe will be moved laterally until the lateral edge of the sacrum is visible, then moved toward the caudal to find the inner direction of the iliac bone. At this location, the sacroiliac joint appears as a wedge-shaped hypoechoic structure. The suitable place for injection is at the level of the second sacral foramen, which is approximately 2-3 centimeters above the caudal surface of the sacroiliac joint. lidocaine1% (manufacturer: Caspian tamin Company. made in Iran) will be injected subcutaneously into the inner edge of the probe. A needle with a 22 gauge in-plane and oblique and anterior position will be inserted into the joint. After the needle is inserted deep into the iliac bone, it is no longer visible with an ultrasound. The popping sound is felt when the synovial joint ruptures. Intervention group Sacroiliac joint injection with fluoroscopic guide: Initially, standard monitoring will be performed throughout the procedure. The patient will be positioned in the prone with the head turned to one side. A pillow is placed under the abdomen to bend the waist. Under the direct anterior-posterior view, the sacroiliac joint shows several lines that point toward the craniocerebral cortex in a semi-parallel pattern. The lateral line shows the ventral or anterior margin of the joint, and the inner line represents the dorsal or posterior margin of the joint. For a better view of the lower areas of the upper posterior iliac and iliac crest, the C-arm is initially rotated 30 degrees from the caudal to the axial plate. The C-arm is angled, usually between 5 and 20 degrees in the opposite direction, until the space of the lower joint is clearly defined. The target area is located along the lower posterior part of the joint 1 to 2 centimeters towards the cephalad from the most caudal point. The target area will be prepared and draped with the usual sterile method. The skin is anesthetized with 1 to 2 cc of lidocaine 1% through needle number 25. Spinal needle Number 22 travels coaxially to the lower bridge of the sacroiliac joint and will be confirmed by giving alternating images at regular intervals (every 2 to 4 millimeters of the needle advance). When the posterior surface of the sacroiliac joint is contacted, the needle goes to the point where it ruptures the joint capsule. Resistance changes will be commonly felt as the needle passes through the capsular tissue, and the tip of the needle usually deflects slightly when it strikes the surface of the ilium. Intensity of pain. Timepoint: Before the procedure, zero time of the procedure, 15 minutes and 24 hours after the procedure. Method of measurement: Based on the Numerical Rating Scale (a scale for pain). Duration of the procedure. Timepoint: At the end of procedure. Method of measurement: Measuring time based on minutes. Complications of the procedure (hypotension,urticaria). Timepoint: During the procedure and at the end. Method of measurement: Blood pressure measurement with mercury sphygmomanometer, patient observation. Vice President of Research Guilan university of medical sciences Approved 2020-12-09 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)