Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections

Sacroiliac Joint Pain Clinical Trial

Official title:

Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944861
• Other study ID #: 35
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: July 2023
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Serdar KESIKBURUN, MD
• Phone: +903122911402
• Email: serdarkb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthralgia
• Sacroiliac Joint Pain
• Sacroiliac Joint Somatic Dysfunction

Intervention

Other:
• Combined ultrasonography and flouroscopy guided injeciton
In the ultrasound+fluoroscopy group, the sacroiliac injection will be started under ultrasound guidance. With the help of ultrasound, when sacral 2 foramen is seen the needle will be advanced to the entrance of the sacroiliac joint under real-time in-plane view. After considering intra-articular placement, fluoroscopy guidance will be initiated. An anteroposterior image will be taken to confirm whether contrast material is within the joint. If intra-articular placement is not achieved after contrast medium infiltration, needle reposition will be performed under fluoroscopy for correct needle placement. After the intraarticular contrast pattern is seen, 1 ml of 40 mg methylprednisolone + 1 ml of 1% lidocaine mixture will be injected.
• Flouroscopy guided injection
In the fluoroscopy group, the advancement of the needle into the sacroiliac joint will be performed by taking anteroposterior and lateral views. In the same way, the needle tip will be placed in the inferior of the sacroiliac joint, and contrast material distribution examination and injection of the drug will be performed as in the ultrasound + fluoroscopy group.

Locations

Country	Name	City	State
Turkey	SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing Time	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	during the intervention
Secondary	Fluoroscopy Time	The fluoroscopy time applied to the patient is automatically measured by the fluoroscopy device. This data will be saved	during the intervention
Secondary	Kerma-area Product (µGy)	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.	during the intervention
Secondary	Visual Analogue Scale	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	baseline, change from baseline VAS at 1 month after intervention
Secondary	Oswestry Low Back Pain Disability Questionnaire	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.	baseline, change from baseline VAS at 1 month after intervention