Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections

Last updated: July 12, 2023
Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Muscle Pain

Lower Back Pain

Treatment

Flouroscopy guided injection

Combined ultrasonography and flouroscopy guided injeciton

Clinical Study ID

NCT05944861
35
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Low back and/or gluteal pain and/or groin pain without radicular extension below theL4 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

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 Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: Flouroscopy guided injection
Phase:
Study Start date:
April 15, 2023
Estimated Completion Date:
November 15, 2023

Study 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.

Connect with a study center

  • SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    Ankara, Cankaya 06800
    Turkey

    Active - Recruiting

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