Comparing the effectiveness of ultrasound-guided versus fluoroscopy-guided sacroiliac joint intra-articular injection in patients with sacroiliac joint disorders
Comparison of the success rate of fluoroscopy and ultrasound guide for sacroiliac joint injection in patients with chronic low back pain
Design
A single-blinded, randomized clinical trial with parallel groups design of 122 patients
Settings and conduct
This study is a clinical trial in pain clinics of Shafa, Razi and velayat hospitals in Rasht. Patients will be selected through convenience sampling and by using randomized blocks will be divided into ultrasound and fluoroscopy groups.The injected drug is Rupivacaine 0.2% (manufacturer: L Molteni,Italy) and methylprednisolone 40milligrams (manufacturer:Caspian tamin Co, made in Iran), which will be done by Sharp curved needle Number 22. Ultrasound device type, 2.5 to 8 MHz ultrasound probe and fluoroscopic images will be obtained through General Electric DEC 9900 C-rm. Patients in both groups will be compared in terms of pain intensity in passive and elective mode based on a numerical ranking scale of 10-point (zero= no symptoms to 10= worst imaginable symptoms) at the times: before the procedures,zero,15 minutes and 24 hours after procedures.The duration of the procedures and complications will also be recorded as well.This study is single-blinded, patients are aware of their treatment and the evaluator is unaware.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients nominated for sacroiliac joint injection due to being positive in at least 4 out of 7 clinical examinations, Average pain at least 3 out of 10 in NRS, Persistent pain for 6 weeks and not responding to conservative treatments.
Exclusion criteria: Indistinguishable distinction between sacroiliac joint pain and L5/S1 fastogenic back pain
Intervention groups
Ultrasound group: Sacroiliac joint injection with ultrasound guide
Fluoroscopic group: Fluoroscopy with sacroiliac guide
Main outcome variables
Pain intensity, Duration of the procedure, Complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170314033069N4
Registration date:2021-01-13, 1399/10/24
Registration timing:prospective
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Gelare Biazar Biazar
Name of organization / entity
Guilan University of Medical Sciences,Alzahra Hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9024
Email address
biazar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of ultrasound-guided versus fluoroscopy-guided sacroiliac joint intra-articular injection in patients with sacroiliac joint disorders
Public title
Comparison of ultrasound and fluoroscopic guided intra-articular sacroiliac injection in patients with sacroiliac joint disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2020-12-09, 1399/09/19
Ethics committee reference number
IR.GUMS.REC.1399.408
Health conditions studied
1
Description of health condition studied
Chronic pain of sacroiliac joint
ICD-10 code
M46.98
ICD-10 code description
Unspecified inflammatory spondylopathy, sacral and sacrococcygeal region
Primary outcomes
1
Description
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)
2
Description
Duration of the procedure
Timepoint
At the end of procedure
Method of measurement
Measuring time based on minutes
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.