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Chronic Sacroiliac Joint PainNCT06935539

Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

A study testing Cryoneurolysis and Radiofrequency ablation in people with Chronic Sacroiliac Joint Pain, run by Medical Pain Management Services, PLLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Sacroiliac Joint Pain
What is being tested?
Cryoneurolysis and Radiofrequency ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
May 2025to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Subjects at least 18 years of age at Screening
  • Primary complaint of buttock or axial low-back below L5 suggestive of unilateral or bilateral SIJ-mediated back pain
  • Positive SIJ provocative testing (at least two tests must be positive)
  • Thigh thrust test
  • Distraction test
  • Gaenslen's test
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  • Compression test
  • Sacral thrust test
  • Low back or buttock pain is chronic (i.e., ≥ 3 months' duration)
  • Low back or buttock pain is moderate to severe (score of ≥ 4 to ≤ 9) on the 0 to 10 NRS at Screening
  • Low back or buttock pain causes functional impairment (≥ 30% on ODI) at Screening
  • Successful trial of one diagnostic sacroiliac joint block with local anesthetic and steroids that results in at least 50% relief of primary (index) pain for the duration of the local anesthetic used
  • Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate analgesics)
  • Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment

Who cannot join

  • Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine
  • Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:
  • Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)
  • Infection
  • Tumor
  • Traumatic fracture
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  • Systemic inflammatory spondyloarthropathy
  • Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)
  • Neurogenic claudication
  • Prior SIJ fusion surgery across the SI joint
  • Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder
  • Currently pregnant, nursing, or planning to become pregnant during the study
  • Known contraindication to study device, including any of the following:
  • Cryoglobulinemia
  • Paroxysmal cold hemoglobinuria
  • Cold urticaria
  • Raynaud's disease
  • Open and/or infected wounds at or near the treatment site
  • Coagulopathy
  • Previous participation in an iovera° study
  • Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes
  • Presence of any of the following:
  • Spinal neurostimulator
  • Intrathecal analgesic drug pump
  • Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:
  • Mood disorder (e.g., depression, bipolar) i. Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening b. Psychotic disorder (e.g., schizophrenia) c. Catastrophizing i. Pain Catastrophizing Scale (PCS) score >30 at Screening
  • Subject received other spine interventions/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels
  • Subject received radiofrequency ablation ≤ 6 months before study enrollment at the intended treatment levels
  • History, suspicion, or clinical manifestation of:
  • Alcohol abuse or dependence
  • Illicit drug use
  • Opioid abuse or dependence (≥40 mg MED PO/day in past 30 days) Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded per Exclusion criterion #4.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kasandra Cliff, MSN, RN contact

518-371-6772 ext. 204

khopkins@northwayspc.com

About this study

Official title: A Prospective, Single-center, Open-label, Pilot Randomized Controlled Study Evaluating the Clinical Effectiveness of Lateral Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Sacroiliac Joint Pain

This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.

Read the detailed description

This is a single-center, randomized, pilot study in adult subjects with chronic SIJ pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation (RFA).

This study is designed to evaluate the clinical effectiveness of iovera° cryoneurolysis in adult subjects with chronic SIJ pain. Furthermore, the study will assess the feasibility of the outcome measurements employed, construct a foundation for sample size calculation, and the acceptability/practicality of conducting an efficacy randomized controlled trial (RCT).

Randomization to treatment groups according to the randomization assignment will be performed on the day of treatment.

Being tested
Cryoneurolysis, Radiofrequency ablation
Keywords
low back pain, chronic low back pain, sacroiliac joint pain, chronic sacroiliac joint pain, cryoneurolysis, radiofrequency ablation
Medical subject headings
Low Back Pain

What participants receive

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

  • CryoneurolysisDevice

    Also called iovera

    The iovera° system consists of a reusable, portable Handpiece, along with single-patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "STT21180STIM" Smart Tip will be used in this study.

  • Radiofrequency ablationDevice

    Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.

Study groups in NCT06935539
Study groupRoleWhat they receive
CryoneurolysisActive comparatorSubjects will receive iovera° cryoneurolysis to the nerves of the sacroiliac joint
Receives: Device: Cryoneurolysis
Radiofrequency ablationActive comparatorSubjects will receive RFA to nerves of the sacroiliac joint
Receives: Device: Radiofrequency ablation

What is being measured

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

  1. Safety and Clinical Effectiveness of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)

    Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.

    Measured: 0-12 months

Secondary outcomes (7)

  1. Pain Intensity

    Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain.

    Subjects will evaluate how much pain they are currently experiencing and their average pain level over the past 24 hours.

    Measured: 0-12 Months

  2. Functional disability

    Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability.

    Measured: 0-12 months

  3. Concomitant medication use

    Concomitant medication use will be collected per participant medication diary.

    Measured: 0-12 months

  4. Success and failure rate of study interventions

    Treatment success or failure will be determined at Day 180 (± 5 days) as described by Birkenmaier et al.:

    1. Full success of treatment is when pain is reduced to 50% or less of pre-treatment levels
    2. Partial success of treatment is when pain is reduced between 51-69% of pre-treatment levels
    3. Failure of treatment is when pain is reduced to 70% or greater of pre-treatment levels

    Measured: Day 180

  5. Shor-form 12 (SF-12)

    Health-related quality of life will be measured by the short-form (SF) 12. The SF-12 is a self administered 12-item questionnaire that assesses an individual's physical and mental health status across eight domains. Total scores range form 0-100 with scores above 50 indicating better-than-average health-related quality of life, and scores below 50 indicating below-average health.

    Measured: Screening, Day 90 (± 5 days), Day 180 (± 5 days), Day 270 (± 7 days), Day 360 (± 7 days)

  6. Satisfaction With Pain Management

    Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied.

    Measured: 12 months

  7. Patients' Global Impression of Change

    The Patients' Global Impression of Change (PGIC) is an 11-point self-report scale assessing overall changes in activity limitations, symptoms, emotions, and quality of life, ranging from 0 to 10, where higher values indicate worse outcomes.

    Measured: 12 months

Timeline

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

  1. First posted20 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionAug 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
Randomization to treatment groups according to the randomization assignment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935539
Sponsor's protocol ID
CRS-131
Status last verified
Apr 2025
First submitted
10 Apr 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Birkenmaier C, Veihelmann A, Trouillier H, Hausdorf J, Devens C, Wegener B, Jansson V, von Schulze Pellengahr C. Percutaneous cryodenervation of lumbar facet joints: a prospective clinical trial. Int Orthop. 2007 Aug;31(4):525-30. doi: 10.1007/s00264-006-0208-6. Epub 2006 Aug 23.

    PubMed 16927087

Questions about this trial

What is this clinical trial studying?

A study testing Cryoneurolysis and Radiofrequency ablation in people with Chronic Sacroiliac Joint Pain, run by Medical Pain Management Services, PLLC.

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 14 inclusion and 32 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: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Kasandra Cliff, MSN, RN (518-371-6772 ext. 204, khopkins@northwayspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Clinical Effectiveness of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA) (time frame: 0-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935539, which also lists 1 linked publication.

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 20 Apr 2025.

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