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Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Primary Purpose

Sacroiliac Joint Arthritis, Back Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Sacral lateral branch radiofrequency ablation under ultrasound guidance

Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

About this trial

This is an interventional treatment trial for Sacroiliac Joint Arthritis

Eligibility Criteria

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

Inclusion Criteria:

Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.
- 50% pain relief after prognostic sacral lateral branch block
At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test]
Refractory to conservative therapy

Exclusion Criteria: The exclusion criteria were;

Uncontrolled psychiatric or neurological illness
Sacroiliac joint pain due to other disorders,
Lumbar radiculopathy
Rheumatological diseases
Systemic active infections
Malignancies, previous surgery on the affected sacroiliac joint,
History of traumatic hip injury,
History of bleeding disorders,
Platelet values < 150.000 / µl,
Sacroiliac joint injection within the preceding 3 months,
Allergy to local anesthetics and steroids,
Pregnancy, inability to concent, Implanted pacemaker or defibrilator.

Sites / Locations

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound guided sacral lateral branch radiofrequency ablation

Fluoroscopy guided sacral lateral branch radiofrequency ablation

Arm Description

Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.

Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.

Outcomes

Primary Outcome Measures

Change in pain numerical rating score from baseline

The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable'

Secondary Outcome Measures

Performance time

Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed

Patient satisfaction

Changes in overall satisfaction will be assessed using a 5-point Likert scale. (1, very dissatisfied; 2, dissatisfied; 3, neutral; 4, satisfied; 5, very satisfied).

Pain medication use

Mean change in analgesic consumption is assessed using QAQ, a tool designed to record patient-reported pain medication use. The higher score indicates higher pain medication use

Success rate

Proportions of reporting >50% pain relief.

Functional disability

Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible

Quality of life ( SF-36)

Quality of life (QoL) will assessed via SF-36, which consists of 36 items ad 2 summary values for Physical Component Summary ( PSC) and Mental Component Summary (MSC). Subscale scores range from 0 to 100, with 100 being the most positive QoL in that area and 0 the lowest;

The number of needle passess

The number of attempts during the performance will be analysed.

Full Information

NCT ID

NCT05520463

First Posted

August 24, 2022

Last Updated

July 6, 2023

Sponsor

Diskapi Teaching and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05520463

Brief Title

Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Official Title

A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

June 25, 2023 (Actual)

Study Completion Date

July 5, 2023 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.

6. Conditions and Keywords

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

Sacroiliac Joint Arthritis, Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound guided sacral lateral branch radiofrequency ablation

Arm Type

Experimental

Arm Description

Patients in this group will receive sacral lateral branch radiofrequency ablation under ultrasound guidance.

Arm Title

Fluoroscopy guided sacral lateral branch radiofrequency ablation

Arm Type

Active Comparator

Arm Description

Patients in this group will receive sacral lateral branch radiofrequency ablation under fluoroscopy guidance.

Intervention Type

Procedure

Intervention Name(s)

Sacral lateral branch radiofrequency ablation under ultrasound guidance

Intervention Description

Sacral lateral branch radiofrequency ablation will be performed under ultrasound guided approach.

Intervention Type

Procedure

Intervention Name(s)

Sacral lateral branch radiofrequency ablation under fluoroscopy guidance

Intervention Description

Sacral lateral branch radiofrequency ablation will be performed under fluoroscopy guided approach.

Primary Outcome Measure Information:

Title

Change in pain numerical rating score from baseline

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Performance time

Description

Radiofrequency ablation performance time will be recorded from the time the first image is obtained, until the procedure is completed

Time Frame

During the procedure

Title

Patient satisfaction

Description

Changes in overall satisfaction will be assessed using a 5-point Likert scale. (1, very dissatisfied; 2, dissatisfied; 3, neutral; 4, satisfied; 5, very satisfied).

Time Frame

At 3 months

Title

Pain medication use

Description

Mean change in analgesic consumption is assessed using QAQ, a tool designed to record patient-reported pain medication use. The higher score indicates higher pain medication use

Time Frame

At 3 months

Title

Success rate

Description

Proportions of reporting >50% pain relief.

Time Frame

At 3 months

Title

Functional disability

Description

Change in Oswestry Disabilit Index ( Scale 0-100). 0 point is equated with no disability and 100 point is maximum disability possible

Time Frame

At 1 and 3 months

Title

Quality of life ( SF-36)

Description

Time Frame

At 1 and 3 months

Title

The number of needle passess

Description

The number of attempts during the performance will be analysed.

Time Frame

During the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale. 50% pain relief after prognostic sacral lateral branch block At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test] Refractory to conservative therapy Exclusion Criteria: The exclusion criteria were; Uncontrolled psychiatric or neurological illness Sacroiliac joint pain due to other disorders, Lumbar radiculopathy Rheumatological diseases Systemic active infections Malignancies, previous surgery on the affected sacroiliac joint, History of traumatic hip injury, History of bleeding disorders, Platelet values < 150.000 / µl, Sacroiliac joint injection within the preceding 3 months, Allergy to local anesthetics and steroids, Pregnancy, inability to concent, Implanted pacemaker or defibrilator.

Facility Information:

Facility Name

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

City

Yenimahalle

State/Province

Ankara

ZIP/Postal Code

06170

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Findings of this study will be available from the principle investigator upon reasonable request.

Citations:

PubMed Identifier

28178092

Citation

Finlayson RJ, Etheridge JB, Elgueta MF, Thonnagith A, De Villiers F, Nelems B, Tran DQ. A Randomized Comparison Between Ultrasound- and Fluoroscopy-Guided Sacral Lateral Branch Blocks. Reg Anesth Pain Med. 2017 May/Jun;42(3):400-406. doi: 10.1097/AAP.0000000000000569.

Results Reference

background

PubMed Identifier

25247902

Citation

Cox RC, Fortin JD. The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. Pain Physician. 2014 Sep-Oct;17(5):459-64.

Results Reference

background

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Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

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