MR-guided Cryoanalgesia for Pelvic Pain

Overseen By Jan Fritz, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Confounding pain syndromes, Previous nerve surgery, Serious medical illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating pelvic pain called MR-guided cryoanalgesia, which freezes nerves to block pain signals. It targets individuals with chronic pelvic pain lasting at least three months who have not found relief through medications or physical therapy. The trial aims to determine if this technique can help those with significant pain from specific nerves, as confirmed by prior nerve block tests. Participants should have persistent, high-level pain despite trying various treatments. As an unphased trial, this study offers patients the chance to explore an innovative treatment option that could provide relief when other methods have failed.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have chronic pelvic pain despite conservative treatments, including oral pain medication, so it might be possible to continue them.

What prior data suggests that MR-guided cryoanalgesia is safe for treating pelvic pain syndromes?

Research has shown that using extreme cold to relieve pain, known as cryoanalgesia, is generally safe. One study on a similar method called cryoablation examined patients with painful tumors and checked for serious side effects. This study supported the safety of using cryoablation for pain relief.

Other research suggests that cryoanalgesia carries a low risk of complications, especially when doctors use imaging to guide the procedure. This imaging helps them perform the procedure more safely. Cryoanalgesia has also been used successfully to relieve chronic nerve pain.

Overall, evidence indicates that MRI-guided cryoanalgesia is well-tolerated and has minimal risks, making it a promising option for managing pelvic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MR-guided Cryoanalgesia is unique because it uses a targeted freezing technique guided by magnetic resonance imaging (MRI) to alleviate pelvic pain syndromes. Unlike standard treatments that often rely on medications or surgical interventions, this method precisely targets the nerves responsible for pain, potentially reducing side effects and improving effectiveness. Researchers are excited about this approach because it offers a minimally invasive alternative that could provide quicker relief and longer-lasting effects compared to traditional therapies.

What evidence suggests that MR-guided cryoanalgesia is effective for pelvic pain syndromes?

Research has shown that MR-guided cryoanalgesia, which uses extreme cold to block nerve signals, holds promise for pain management. Various studies have found that this technique significantly reduces pain for 50-60% of patients, with effects lasting 6 to 12 months. By precisely targeting specific nerves using MRI, it offers relief, especially for those who haven't succeeded with other treatments. While some studies showed no major improvement, others demonstrated clear pain reduction compared to groups not receiving the treatment. Overall, cryoanalgesia offers hope for those with ongoing pelvic pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Jan Fritz, M.D

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

Pain must be from a single lumbosacral nerves confirmed with selective nerve blocks providing adequate temporary pain. The selectivity of the nerve block will be confirmed on MR images documenting that the injected local anesthetic immerses the targeted nerve and that there is absence of spread of local anesthetic to adjacent nerves to exclude confounding anesthesia. Adequate pain relief will be defined by pain relief of greater 50% after the nerve block and rest and with aggravating exercise.

No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up

You must rate your worst pain as 4 or higher on a scale of 0 to 10.

Exclusion Criteria

Currently pregnant, nursing, or wishing to become pregnant during the study

Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit

You are currently participating in other studies that could impact the main goal of this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MR neurography-guided cryoanalgesia for pelvic pain syndromes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Multiple visits at 1, 3, 6, 9, 12, and 18 months post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• MR-guided Cryoanalgesia

How Is the Trial Designed?

Group I: Pelvic pain syndromes Experimental Treatment 1 Intervention

Patients with pelvic pain syndromes who will undergo MR neurography-guided cryoanalgesia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

BTG International Inc.

Collaborator

Trials

43

Recruited

3,100+

Published Research Related to This Trial

In a study involving 113 patients undergoing ultrasound-guided percutaneous cryoneurolysis for spasticity, 96.75% of nerve treatments resulted in no significant pain or dysesthesias beyond the treatment period, indicating a high safety profile.

While a few patients experienced temporary nerve pain or numbness, most adverse effects were manageable and resolved within three months, suggesting that cryoneurolysis could be a safe and effective treatment option for spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity. Winston, P., MacRae, F., Rajapakshe, S., et al.[2023]

This study aims to evaluate the safety of cryoablation in 10 patients with painful bone and soft tissue tumors, focusing on the prevalence of severe adverse events within 4 weeks post-treatment.

The effectiveness of cryoablation will also be assessed 4 weeks after the procedure, providing insights into its potential as a pain management option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502). Iguchi, T., Sakurai, J., Hiraki, T., et al.[2017]

Cryoanalgesia, or cryoneurolysis, is a safe and effective method for relieving pain by applying extreme cold to peripheral nerves, interrupting pain signals without causing permanent nerve damage.

This technique, guided by imaging methods like ultrasound or CT, offers a minimally invasive alternative to traditional pain management approaches, especially important in the context of the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoanalgesia for pain palliation: Current status and future trends. Filippiadis, D., Efthymiou, E., Tsochatzis, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04046406

Pelvic Pain Treated With MR-guided Cryoanalgesia The objective of this study is to evaluate the effectiveness of magnetic resonance (MR) neurography-guided cryoanalgesia for the treatment of pelvic and ...

2. withpower.com withpower.com/trial/phase-pelvic-pain-10-2019-89cff

Pelvic Pain Treated With MR-guided Cryoanalgesia This trial is testing a new method to relieve pelvic pain by freezing specific nerves using MRI guidance. It targets patients who haven't found relief from ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11931670/

Cryoneurolysis: A Comprehensive Review of Applications in ... Cryoneurolysis, a technique that uses extreme cold to disrupt nerve conduction, has demonstrated potential in managing both acute and chronic pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211568420302965

Percutaneous cryoanalgesia for pain palliation Data from prospective studies show favorable results (50–60% of patients with significant pain reduction) for 6–12 months [6], [30], [37], [38], [43], [49], [56] ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12194836/

Innovations in Chronic Pain Treatment: A Narrative Review on ... While two RCTs demonstrated a significant pain reduction compared to control groups, other RCTs reported no significant improvement. Observational studies and ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482123/

Cryoanalgesia - StatPearls - NCBI Bookshelf - NIH Cryoanalgesia is a specialized technique for providing long-term pain relief in interventional pain management settings.

7. mdpi.com mdpi.com/1648-9144/61/6/1090

Innovations in Chronic Pain Treatment: A Narrative Review ... Cryoneurolysis is a safe technique for chronic pain management, which has been successfully applied, particularly for selected neuropathic pain conditions.