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Clinical Trials/NCT04446988
NCT04446988CompletedNot Applicable

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

Minia University2 sites in 1 country40 target enrollmentStarted: October 15, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Numeric Rating Scale (NRS) pain scores
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Sacroiliac joint injection in sacroiliitis

Detailed Description

Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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/m
  • •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).

Outcomes

Primary Outcomes

Numeric Rating Scale (NRS) pain scores

Time Frame: 3 months

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

Oswestry disability index score

Time Frame: 1 month

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

Secondary Outcomes

  • Procedure time(Procedure)
  • Analgesic requirement(1 month)
  • Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )(3 months)

Investigators

Sponsor
Minia University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

DR. Abd El-Raheem Mahmoud

Clinical Professor

Minia University

Study Sites (2)

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