Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections. A Randomised Controlled Trial

NCT05944861 | Completed

• 1 other identifier: 35
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Somatic Dysfunction; Sacroiliac Joint Pain

Keywords

Sacroiliac joint pain; Sacroiliac joint injection; Ultrasonography guided injection; Flouroscopy guided injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fluoroscopy Time

  during the intervention

• Kerma-area Product (μGy)

  during the intervention

• Visual Analogue Scale

  baseline, change from baseline VAS at 1 month after intervention

• Oswestry Low Back Pain Disability Questionnaire

  baseline, change from baseline VAS at 1 month after intervention

Study Arms (2)

Combined ultrasonography and flouroscopy guided injeciton

EXPERIMENTAL

In 19 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy.

Other: Combined ultrasonography and flouroscopy guided injeciton

Flouroscopy guided injection

ACTIVE COMPARATOR

In 19 patients selected after randomization, the procedure will be performed only through fluoroscopy.

Other: Flouroscopy guided injection

Interventions

Combined ultrasonography and flouroscopy guided injeciton OTHER

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.

Combined ultrasonography and flouroscopy guided injeciton

Flouroscopy guided injection OTHER

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.

Flouroscopy guided injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Study Officials

• Serdar KESIKBURUN, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: July 13, 2023
• Study Start: February 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)