Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections

July 12, 2023 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06800
        • Recruiting
        • SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
        • Contact:
        • Contact:
          • Serdar KESIKBURUN, MD, Associate Professor
          • Phone Number: +903122911402
          • Email: serdarkb@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: Flouroscopy guided injection
In 17 patients selected after randomization, the procedure will be performed only through fluoroscopy.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Principal Investigator: Serdar KESIKBURUN, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

November 15, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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