Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Radiofrequency Ablation

May 26, 2022 updated by: University of Alberta

Efficacy of Fluoroscopic Versus Ultrasound Guided Sacroiliac Joint Radiofrequency Ablation: A Randomized Control Trial

The sacroiliac joint (SIJ) is estimated to be the source of low mechanical back pain in 10-27% of patients. When conservative measures for treating SIJ pain fail (physiotherapy, exercise, analgesic medications, chiropractic manipulation, etc.) radiofrequency ablation (RFA) is a treatment option in carefully selected patients. RFA uses a radiofrequency generator to create a thermal lesion, with the aim of ablating the nerves that innervate the SIJ complex. Studies have confirmed that SIJ RFA can provide significant relief for patients with SIJ pain. The current gold standard is the use of fluoroscopic (x-ray guidance) to visualize bony landmarks in order to create an accurate thermal lesion along the lateral sacral crest; where the nerves that innervate the SIJ complex reside. Recent literature has proposed a technique for an ultrasound-guided approach to achieve an RFA lesion in patients with SIJ pain. It is proposed that with ultrasound-guidance, versus fluoroscopic-guidance, the interventionalist is able to perform fewer needle passes for the procedure, as well as fewer thermal lesions, thereby achieving shorter performance times. The proposed study serves as a non-inferiority randomized controlled trial to assess the effectiveness of ultrasound-guided versus fluoroscopy-guided RFA for the treatment of SIJ pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Current practice for SIJ pain that is refractory to conservative treatment, is the use of RFA of the posterior sacral network under fluoroscopic-guidance. There is high variability regarding the long-term benefits of this procedure. To date, there have been no clinical studies evaluating the effectiveness of US-guided RFA procedures for SIJ pain. A study performed in 2017 attempted to determine the effectiveness of US-guided sacral LBBs compared to fluoroscopic-guidance (gold standard in current practice). The results were in favour of an US-guided approach. Compared with fluoroscopy, US-guided sacral lateral branch blocks required a shorter performance time, fewer needle passes, and was associated with a lower incidence of vascular breach. Furthermore, with an US-guided procedure, the patient is no longer exposed to ionizing radiation.With an improved understanding of SIJ sensory innervation, as well as technical improvements in RFA electrodes, it is postulated that RFA under ultrasound-guidance will lead to non-inferior clinical outcomes, as well as shorter performance time and reduced costs compared with the current practice of fluoroscopic-guidance.

The objectives of the current study are the following:

  1. To evaluate the efficacy of US-guided posterior sacral network SIJ RFA compared to fluoroscopy-guided SIJ RFA.
  2. To compare the post-procedure pain/flare-up and duration required to achieve full recovery for each approach.
  3. To perform a cost effectiveness analysis comparing ultrasound and fluoroscopy-guided SIJ RFA.
  4. To determine the safety of US-guided SIJ RFA by tracking intra-operative and post-procedure complications.

Research Method/Procedures:

The proposed study is a single-blind, single-center randomized controlled trial. Patients who present with pain thought to be originating from the SIJ will be screened for study participation with fluoroscopy-guided sacral LBBs. If a patient has an initial successful sacral LBB (defined as 70% reduction in pain), or has prior successful SIJ RFA, they will be approached for consent to be contacted for study participation by a member of the HealthPointe team; specifically, patients who consent to be contacted for study participation, will have their charts reviewed by independent assessors for inclusion and exclusion criteria. If a patient meets the inclusion criteria (listed below), they will be contacted by a HealthPointe team member, specifically a nurse or care manager, for study participation. If the patient expresses an interest with the initial contact, they will be subsequently contacted by a study sub-investigator.

Upon obtaining written consent for study participation, patients will be randomized into one of two groups; US-guided SIJ RFA or fluoroscopy-guided SIJ RFA (current gold-standard). Upon being randomized to either group they will then undergo a second confirmatory sacral LBB under their respective image guidance to confirm candidacy for RFA. If this second, confirmatory LBB is successful (70% pain relief or more) the patient qualifies for RFA. Then, SIJ RFA will be performed under each respective imaging modality and patients will be followed to document pain improvement, functional outcomes, quality of life and medication use for 18 months. Study participants will be asked to perform a daily VAS pain diary for the first 6 weeks post-procedure in order to document post-procedure pain flare. Questionnaires will be administered either in person (if appropriate), or by email or over the phone, at 6 weeks, 12 weeks, 6 months, 12 months and 18 months post-RFA procedure.

The primary endpoint is 12 months post-procedure, however the investigators plan to follow for 18 months to determine long-term effectiveness. The investigators will perform an interim-analysis at the 6-month follow-up time period.

In further analyses, the effect of the intervention groups on secondary outcomes listed below will be evaluated:

The average time (in days) for post-procedure pain flare. Pain medication use post-procedure (% increase or decrease from baseline). Participation in physiotherapy and exercise programs (as a binary variable: yes or no) Cost effectiveness analysis comparing procedures based on the following mean data: performance time, radiation time, number of thermal lesions performed, number of RFA needle passes, volume of local anesthetic used. Cost will be compared based on mean data for fluoroscopy- and ultrasound-guided procedures, as well as the cost of monopolar vs. bipolar RFA.

Safety: this will include intra-operative complications related directly to the intervention, as well as post-operative complications and adverse events over the study duration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6X 0S8
        • HealthPointe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18
  • Body Mass Index (BMI) ≤35
  • Clinical presentation must be in keeping with SIJ pain based on both history (pain below L5 vertebrae, localized to the SIJ area, back pain greater than leg pain) and/or physical examination (≥2/5 SIJ provocative tests).
  • Diagnosis confirmed by having >70% index pain relief with fluoroscopy-guided SIJ lateral branch blocks (with local anesthetic). Participants will require confirmatory lateral branch block under their respective image modality once randomized, requiring >70% pain relief for diagnosis, prior to completing the randomized SIJ RFA procedure.

Exclusion Criteria:

  • Age <18
  • Pregnant or inadequate birth control methods (to prevent the exposure of a pregnant female and/or fetus to radiation).
  • Inflammatory spondyloarthropathy
  • Fibromyalgia
  • Radiculopathy (will require an electromyography study to rule out radiculopathy if clinically suspected in patients with primarily buttock pain)
  • Discogenic low mechanical back pain
  • Symptomatic spinal stenosis
  • Generalized or local infection
  • Coagulopathy
  • Allergy to local anesthetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ultrasound-Guided SIJ RFA

Utilizing short axis views, the S1, S2 and S3 foramen and tubercles would be localized and marked by a surgical skin marker. Then, the ultrasound transducer will be moved laterally to achieve a long axis view between the S1 and S2 tubercle. Local skin and subcutaneous tissue freezing would be performed with Lidocaine 1% utilizing a 30-gauge needle. An 18-gauge radiofrequency (RF) cannula will be directed utilizing an in-plane approach toward the S2 and S3 lateral branches between the S2 and S3 tubercles. A small amount of 1% lidocaine will be injected in order to provide comfort.

The RF generator will be set to continuous monopolar RF ablation and the needle will be heated to 80 degrees Celsius for 90 seconds. The needle will then be repositioned proximally to obtain a slightly larger burn in a similar fashion previously described. A similar approach will be utilized for the S1 lateral branch RF ablation between the S1 and S2 tubercles.
Procedure: Ultrasound-guided Radiofrequency Ablation
Radiofrequency ablation of the posterior SIJ complex under ultrasound-guidance
Active Comparator: Fluoroscopic-Guided SIJ RFA
An anterior-posterior approach is used to identify the S1-S3 foramen. A 3-inch spinal needle would be used for marking. Local tissue freezing would be accomplished with Lidocaine 1% and a 30-G needle. An 18-G RF cannula will be positioned over the 12 o'clock position of the S1 foramen and a second cannula placed in the 2 o'clock or 10 o'clock position for the right and left respectively (4-5 mm distance between the cannula). A small amount of 1% lidocaine will be injected for comfort. A lateral projection is taken to ensure the needles are not placed into the foramen. The RF generator will be set to continuous bipolar RF ablation and heated to 80 degrees Celsius for 90 seconds. Then another 18-G RF cannula will be positioned at the 4 o'clock or 8 o'clock position (4-5 mm distance between the cannula) to achieve the second RF ablation. The third RF ablation will be performed with the RF cannula at the 6 o'clock position. An identical fashion is utilized at the S2 and S3 foramen.
Procedure: Fluoroscopic-guided Radiofrequency Ablation
Radiofrequency ablation of the posterior SIJ complex under fluoroscopic-guidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain reduction: change from baseline pain scores
Time Frame: 6 weeks to 18 months post-procedure.
Visual analog scale (VAS) for pain at the various follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
6 weeks to 18 months post-procedure.
Function and quality of life
Time Frame: 6 weeks to 18 months post-procedure.
Pain, Disability and Quality of Life Questionnaire- Spine (PDQQ-S)
6 weeks to 18 months post-procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-procedure pain flare
Time Frame: Daily visual analog scale (VAS) for pain for the first 6 weeks.
Daily visual analog scale (VAS) for pain for the first 6 weeks post-procedure to document post-procedure pain flare. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
Daily visual analog scale (VAS) for pain for the first 6 weeks.
Pain medication usage
Time Frame: 6 weeks to 18 months post-procedure.
Percentage increase or decrease from patients baseline.
6 weeks to 18 months post-procedure.
Cost effectiveness
Time Frame: Costs compared based on procedural data upon study completion, an average of 18 months.
Compare study arms based on the following mean data; performance time, radiation time, number of thermal lesions performed, number of RFA needle passes, volume of local anesthetic used. Cost will be compared based on mean data for fluoroscopy- and ultrasound-guided procedures, as well as the cost of monopolar vs. bipolar RFA
Costs compared based on procedural data upon study completion, an average of 18 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participation in physical therapy
Time Frame: 6 weeks to 18 months post-procedure.
Binary variable (yes/no) to document confounding data.
6 weeks to 18 months post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shane Hoeber, M.D., University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00102343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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