AzTrials
AzTrials

Sprain of Sacroiliac LigamentNCT02335190

Ultrasound-guided Sacroiliac Joint Radiofrequency Ablation: A Pilot Study

A study testing Radiofrequency ablation, Sensory block and Lidocaine in people with Sprain of Sacroiliac Ligament and Low Back Pain, run by Western University, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA) can be used to treat low back pain from the SI joint , and is often recommended by physicians to provide long lasting pain relief. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiofrequency ablation, Sensory block and Lidocaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
Sep 2015to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Clinical presentation compatible with SI joint origin pain (back pain below L5; localized to the SI joint area; >2 positive of 5 SI joint provocative tests).
  • >50% index pain relief with at least one SIJ intra-articular local anesthetic block and at least one SIJ lateral branch block using the conventional fluoroscopically guided lateral branch block technique. Pain diary records for these interventions need to be on file.

Who cannot join

  • Under 18 years of age
  • Presence of clinical and investigative evidence of inflammatory spondyloarthropathy, fibromyalgia, radiculopathy, symptomatic spinal stenosis, facetogenic or discogenic low back pain, generalized infection, localized infection in the area of the low back/SIJs, coagulopathy or anticoagulation, allergy to local anesthetic

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Joseph's Pain Clinic

    London, Ontario, N6A4V2

Other trials in Canada

About this study

The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA) can be used to treat low back pain from the SI joint , and is often recommended by physicians to provide long lasting pain relief. However, the use of RFA for SI joint pain has not been as successful as RFA for pain in other areas of the back and neck. X-ray guidance (fluoroscopy) is currently used to perform this procedure. Under fluoroscopy, however, it can be difficult for physicians to identify necessary landmarks, and there are risks to the patient because of radiation exposure. In contrast, ultrasound may provide better image guidance than fluoroscopy, and there is no radiation risk. The purpose of this study is to examine if ultrasound guided SI joint RFA is effective.

Read the detailed description

Background:

This study will examine the effectiveness of sacroiliac joint (SIJ) diagnostic sensory blocks and radiofrequency ablation (RFA) under ultrasound guidance. The sacroiliac joint (SIJ) is estimated to be the source of pain in 10-27% of patients suffering from mechanical low back pain. When pain is refractory to conventional treatments (such as activity modification, exercise, physical therapy, chiropractic, anti-inflammatory and analgesic medications and corticosteroid injections), radiofrequency ablation (RFA) is a treatment option in carefully selected individuals.

Current practice is to perform the SIJ posterior sensory blocks and RFA under fluoroscopic guidance. Research has confirmed that SIJ RFA can provide significant relief, however, the success rate and magnitude of relief are variable. Part of this variability may relate to the challenging nature of identifying key anatomical landmarks under fluoroscopy - their location may not be clearly evident with fluoroscopy particularly if the patient is obese, has low bone mineral density or has abundant bowel gas and/or stool in the pelvis.

A recent cadaveric study by our research group has clarified the sensory innervation of the SIJ and the findings have implications for currently practiced SIJ sensory block and RFA procedures. The study confirmed that the posterior sacral network innervates the SIJ and runs along the lateral crest of the sacrum between the S1 and the S3 lateral sacral tubercles. Inasmuch as the lateral sacral crest is predictably and clearly visible on ultrasound, posterior sacral network (PSN) SIJ sensory blocks and RFA under ultrasound guidance may be feasible using the lateral sacral crest as the key anatomical structure.

No clinical studies have been done that use ultrasound guidance for SIJ RFA. There are numerous advantages to ultrasound-guided SIJ sensory block and RFA. Significantly, patients would no longer be exposed to ionizing radiation for their SIJ procedures. With an improved understanding of SIJ sensory innevation and technical improvements in RFA electrodes, we hypothesize that ultrasound guided SIJ diagnostic sensory blocks and RFA will lead to clinically significant outcomes that will be at least comparable to conventional fluoroscopic-guided techniques.

Objectives:

  1. To evaluate the relative effectiveness of ultrasound-guided PSN sacroiliac joint sensory block compared to fluoroscopic-guided lateral branch sacroiliac joint block.
  2. To evaluate the relative effectiveness of ultrasound-guided PSN sacroiliac joint radiofrequency ablation compared to fluoroscopic-guided lateral branch sacroiliac joint RFA.

Methodology:

This study is a prospective cohort study examining the effectiveness of ultrasound-guided SIJ sensory block and RFA of the PSN, compared to fluoroscopic guided SIJ RFA. Participants will first undergo a local anesthetic block under ultrasound guidance to determine the predictive value of this test for SIJ RFA; they will then undergo the SIJ RFA procedure. For some patients in this study, this will be a repeat RFA procedure as they would have had a previous fluoroscopic-guided SIJ RFA with success, but subsequent return of their pain.

SIJ Sensory Block: Eligible study subjects will initially undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. Their index pain intensity prior to the block must be >2/10. Under ultrasound guidance, 0.5 mL of 2% lidocaine will be injected from the inferomedial border of the PSIS to the third transverse sacral tubercle at approximately 1.5 cm intervals along the skin surface. Following the local anesthetic block, the subject will be asked to complete a pain diary for 6 hours. Specifically, their baseline pain will be reassessed and their ability to perform functional activities will also be assessed over that time period. The results of this block will be compared to the results of conventional blocks done under fluoroscopy.

SIJ RFA: Ultrasound-guided RFA of the PSN will be performed using the same technique as the local anesthetic block with the exception that 2 Nimbus multitined electrodes will be used in a bipolar configuration. The electrodes will be placed along the lateral crest using a sequential, leap-frogging technique from the inferomedial aspect of the PSIS (at or just above the level of the S1 dorsal sacral foramen if visible, or the S1 spinous process if not) to the third transverse sacral tubercle at 1.5-2 cm intervals at the skin surface. A radiofrequency current will be passed for 120 seconds per site thus raising the temperature at the dorsal periosteum and adjacent soft tissue to 80°C resulting in thermal coagulation of the plexus. Prior to performing the thermal lesion, electrical stimulation at 2 Hz and 2.0 V will be administered. If the patient perceives, or the operator observes muscle contraction of the leg or anal sphincter, no radiofrequency current will be applied and the needle tip will be adjusted to a position away from where the sacral nerve roots may lie.

Analysis:

The effectiveness of ultrasound-guided sensory blocks and RFA will be directly compared to the effectiveness of fluoroscopic-guided sensory blocks and RFA. In patients who have had the SIJ RFA procedure previously, their current ultrasound-guided PDQQ-S scores will be compared to their previous fluoroscopic-guided PDQQ-S results. In patients who are receiving the SIJ RFA procedure for the first time, a database of SIJ RFA PDQQ-S scores of patients treated over the past 5 years with the fluoroscopic-guided RFA technique is available for comparison. Their results will be compared to age and pre-RFA matched patients from the database.

Being tested
Radiofrequency ablation, Sensory block, Lidocaine
Keywords
Sacroiliac joint, Radiofrequency ablation, Ultrasound
Medical subject headings
Low Back Pain, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency ablationProcedure or surgery

    Also called RF ablation

    RF ablation will be performed using 2 Nimbus multitined electrodes in a bipolar configuration. The electrodes will be placed along the lateral crest using a leap-frogging technique from the inferomedial aspect of the PSIS to the third transverse sacral tubercle at 1.5-2 cm intervals at the skin surface. A radiofrequency current will be passed for 120 seconds per site resulting in thermal coagulation of the plexus. Prior to performing the thermal lesion, electrical stimulation at 2 Hz and 2.0 V will be administered.

  • Sensory blockProcedure or surgery

    Also called Posterior sacral network block, PSN block

    Participants will undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. 0.5 mL of 2% lidocaine will be injected from the inferomedial border of the PSIS to the third transverse sacral tubercle at approximately 1.5 cm intervals along the skin surface.

  • LidocaineDrug

Study groups in NCT02335190
Study groupRoleWhat they receive
PSN block and RF ablationExperimentalParticipants will first undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. On a separate visit, participants will then undergo ablation of the PSN at the lateral crest under ultrasound-guidance.
Receives: Procedure: Radiofrequency ablation; Procedure: Sensory block; Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric rating scale for pain

    Pain diary scores for first 6 hours post-block

    Measured: Hourly for 6 hours post-block

  2. Pain Disability Quality-of-Life Questionnaire (PDQQ-S)

    The PDQQ-S is a 6 item questionnaire exploring 3 domains: pain, disability and quality-of-life. There are 2 questions for each domain and each is graded from 0 to 10 using a numerical rating scale. Ultrasound-guided SIJ RFA results will be compared to previous fluoroscopic-guided SIJ RFA results at 2 months.

    Measured: 2 months post-RF procedure

Secondary outcomes (1)
  1. Pain Disability Quality-of-Life Questionnaire (PDQQ-S)

    Secondary outcome will be the duration of improvement on the PDQQ-S, and will be measured by repeat administration of the PDQQ-S every 3-4 months up to 24 months post-procedure. If there is ongoing, clinically significant relief at 6 months (>30% improvement in pain intensity and/or at least 2 point improvement on the pain severity question (question #1) of the PDQQ-S), patients will be reached by phone to complete the PDQQ-S at 3-month intervals up to 12 months post-RFA and then at 4-month intervals up to 24 months, or until their pain intensity returns to baseline (<30% improvement and/or <2 point improvement on question 1 of the PDQQ-S on 2 consecutive follow-ups), whichever comes first.

    Measured: 6, 9, 12, 16, 20 and 24 months post-RF procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02335190
Sponsor's protocol ID
8368-US
Status last verified
Apr 2019
First submitted
5 Jan 2015
Last updated
1 May 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation, Sensory block and Lidocaine in people with Sprain of Sacroiliac Ligament and Low Back Pain, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric rating scale for pain (time frame: Hourly for 6 hours post-block). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in