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

Primary Purpose

Sacro-Iliac Spondylosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sacroiliac joint injection
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacro-Iliac Spondylosis focused on measuring Sacroiliac

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • ASSIUT University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasound(US)

Fluoroscopy(FL)

Arm Description

Sacroiliac joint injection using ultrasound

Sacroiliac joint injection using fluoroscopy

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS) pain scores
It measures pain intensity (0 no pain - 10 worst pain imaginable)
Oswestry disability index score
It evaluates the physical function (0% minimal disability - 100% bed - bound patient)

Secondary Outcome Measures

Analgesic requirement
It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)
Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)
Procedure time
It measures the seconds of procedure in both groups

Full Information

First Posted
May 19, 2020
Last Updated
June 23, 2020
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04446988
Brief Title
Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
Official Title
Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sacroiliac joint injection in sacroiliitis
Detailed Description
Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacro-Iliac Spondylosis
Keywords
Sacroiliac

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound(US)
Arm Type
Experimental
Arm Description
Sacroiliac joint injection using ultrasound
Arm Title
Fluoroscopy(FL)
Arm Type
Experimental
Arm Description
Sacroiliac joint injection using fluoroscopy
Intervention Type
Device
Intervention Name(s)
Sacroiliac joint injection
Intervention Description
Injection of sacroiliac joint with local anesthetic and steroid
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) pain scores
Description
It measures pain intensity (0 no pain - 10 worst pain imaginable)
Time Frame
3 months
Title
Oswestry disability index score
Description
It evaluates the physical function (0% minimal disability - 100% bed - bound patient)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Analgesic requirement
Description
It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)
Time Frame
1 month
Title
Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
Description
It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)
Time Frame
3 months
Title
Procedure time
Description
It measures the seconds of procedure in both groups
Time Frame
Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Ka Mickhael, Ass. pr.
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASSIUT University Hospitals
City
Assiut
ZIP/Postal Code
1225
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23193287
Citation
Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27.
Results Reference
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Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain

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