Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Sacroiliac Joint Pain; Sacroiliac Joint Somatic Dysfunction

Treatments: Other: Flouroscopy guided injection; Other: Combined ultrasonography and flouroscopy guided injeciton

Study type: Interventional

Funder types: Other

Identifiers

NCT05944861

35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Combined ultrasonography and flouroscopy guided injeciton

Experimental group

Description:

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

Treatment:

Other: Combined ultrasonography and flouroscopy guided injeciton

Flouroscopy guided injection

Active Comparator group

Description:

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

Treatment:

Other: Flouroscopy guided injection