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Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound-guided sacroiliac joint injection
Flouroscopy-guided sacroiliac joint injection
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Low back and/or gluteal pain without radicular extension for more than 3 months
  • Tenderness over the SI joint
  • Pain score > 3 by Visual Analogue Scale

Exclusion Criteria:

  • Malignancy
  • Generalized or local infection
  • Coagulopathy
  • Allergy to drugs to be injected

Sites / Locations

  • Diskapi Yildirim Beyazit Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluoroscopic-guided sacroiliac joint injection

Ultrasound-guided sacroiliac joint injection

Arm Description

Outcomes

Primary Outcome Measures

Reduction in pain
Pain assessment will be performed using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = the most severe pain felt).

Secondary Outcome Measures

Oswestry Disability Index (ODI)
Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.
Patient satisfaction Questionnaire
Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Quantitative analgesic questionnaire
A tool designed to record patient-reported pain medication use, create scores to quantify and compare it and track changes in analgesic drug use over time. A higher score indicates higher pain medication use
Procedure time
Procedure time was measured using a stopwatch. It was defined as the time from the start of the procedure, the initial image was obtained or first probe placement, until the end of the procedure defined as;transforaminal needle placement was seen clearly.

Full Information

First Posted
February 2, 2022
Last Updated
October 28, 2022
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05235295
Brief Title
Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection
Official Title
Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
The investigators aimed to evaluate the effectiveness of intra-articular sacroiliac joint injection under fluoroscopy versus ultrasound guidance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoroscopic-guided sacroiliac joint injection
Arm Type
Experimental
Arm Title
Ultrasound-guided sacroiliac joint injection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided sacroiliac joint injection
Intervention Description
Using ultrasound the sacral hiatus in transverse position was identified. Then, sliding laterally and cephalad in transverse position, the posterior superior iliac spine and the posterior sacroiliac joint were identified. The needle was advanced toward the posterior joint space from medial to lateral, using an in-plane technique.
Intervention Type
Procedure
Intervention Name(s)
Flouroscopy-guided sacroiliac joint injection
Intervention Description
Using anterior posterior and contralateral oblique view the posterior joint line and inferior joint margin were identified and a needle was advanced at the point the posterior inferior joint line was most clearly seen.
Primary Outcome Measure Information:
Title
Reduction in pain
Description
Pain assessment will be performed using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = the most severe pain felt).
Time Frame
Change from baseline pain score at 3 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.
Time Frame
Baseline to 3 months post-procedure
Title
Patient satisfaction Questionnaire
Description
Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Time Frame
baseline to 3 months post-procedure
Title
Quantitative analgesic questionnaire
Description
A tool designed to record patient-reported pain medication use, create scores to quantify and compare it and track changes in analgesic drug use over time. A higher score indicates higher pain medication use
Time Frame
at 3 months post-procedure
Title
Procedure time
Description
Procedure time was measured using a stopwatch. It was defined as the time from the start of the procedure, the initial image was obtained or first probe placement, until the end of the procedure defined as;transforaminal needle placement was seen clearly.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Low back and/or gluteal pain without radicular extension for more than 3 months Tenderness over the SI joint Pain score > 3 by Visual Analogue Scale Exclusion Criteria: Malignancy Generalized or local infection Coagulopathy Allergy to drugs to be injected
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection

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