Pelvic Pain Treated With MR-guided Cryoanalgesia

Overseen By Jan Fritz, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

Trial Summary

What is the purpose of this trial?

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 other treatments, especially those with pain after pelvic trauma or surgery. The freezing stops the nerves from sending pain signals, providing relief for an extended period.

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 data supports the effectiveness of the treatment MR-guided Cryoanalgesia?

Cryoanalgesia, which uses extreme cold to reduce pain by interrupting nerve signals, is considered safe and effective for pain relief with minimal risk of complications. Imaging guidance, like MRI, helps make the procedure more precise and less invasive, offering a promising alternative to pain management, especially during the opioid crisis. ^{1 2 3 4 5}

Is MR-guided Cryoanalgesia safe for humans?

MR-guided cryoablation, a similar procedure, has been studied for safety in treating kidney tumors, bone and soft tissue tumors, and brain tumors. These studies generally report that the procedure is safe, with a focus on monitoring for severe adverse events shortly after treatment. ^{2 4 6 7 8}

How does MR-guided Cryoanalgesia differ from other treatments for pain management?

MR-guided Cryoanalgesia is unique because it uses extreme cold to interrupt nerve signals that cause pain, without causing permanent nerve damage. This treatment is guided by MRI, which provides precise imaging to ensure accurate targeting of the affected nerves, making it a minimally invasive alternative to traditional pain management methods, especially in the context of the opioid crisis. ^{3 4 9 10 11}

Research Team

Jan Fritz, M.D

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

You are between 18 and 100 years old.

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

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

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

Treatment Details

Interventions

• MR-guided Cryoanalgesia

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

MR imaging-guided percutaneous cryotherapy for lung tumors: initial experience. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Oncologic Outcomes of Magnetic Resonance Imaging-Guided Cryoablation of Renal Cell Carcinoma: A 10-Year Single-Center Experience. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Percutaneous cryoanalgesia for pain palliation: Current status and future trends. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Experimental Investigation of Cryoneedle Heating during MR-Guided Cryoablation in Ex Vivo Tissue Samples at 1.5-Tesla. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

A new image navigation system for MR-guided cryosurgery. [2019]

6. Japan 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). [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

MR imaging-guided cryoablation of metastatic brain tumours: initial experience in six patients. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

MR imaging assisted temperature calculations during cryosurgery. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of frozen tissues: temperature-dependent MR signal characteristics and relevance for MR monitoring of cryosurgery. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

[Minimally invasive therapy under image guidance--emphasizing MRI-guided cryotherapy]. [2014]