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OpenTrials
Completed

NCT Number: NCT04446988

Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain

Sacroiliac joint injection in sacroiliitis

Completed

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Key information

Conditions

Sacro-Iliac Spondylosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASSIUT University Hospitals

Asyut, 1225, Egypt

About this study

Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of sacroiliitis.
  • At least 3 positive physical examination maneuvers [FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test],
  • Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
  • Age from 18ys to 60ys.

Exclusion criteria

  • Ages less than 18 or more than 85 years.
  • Body Mass Index (BMI) above 35 kg/m2.
  • A diagnosis of severe anxiety or depression and other psychological disorders.
  • Allergy to local anesthetics or steroids and pregnancy.
  • Multiple comorbidities (renal , hepatic, cardiac).
  • Coagulation disorder as bleeding tendency and platelet dysfunction.
  • Contraindication for prone position or radiological exposure.
  • Patient refuse .
  • Pain suggestive of bilateral sacroiliac joint involvement (it would have been difficult to assess pain and disability secondary to each SIJ).

Treatment and study plan

Sacroiliac joint injection

Device

Injection of sacroiliac joint with local anesthetic and steroid

Primary outcomes

  1. Numeric Rating Scale (NRS) pain scores

    Time frame: 3 months

    It measures pain intensity (0 no pain - 10 worst pain imaginable)

  2. Oswestry disability index score

    Time frame: 1 month

    It evaluates the physical function (0% minimal disability - 100% bed - bound patient)

Secondary outcomes

  1. Analgesic requirement

    Time frame: 1 month

    It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)

  2. Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )

    Time frame: 3 months

    It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)

  3. Procedure time

    Time frame: Procedure

    It measures the seconds of procedure in both groups

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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