Study Summary
This trial evaluates the effectiveness of cryoanalgesia, a treatment for pelvic pain that uses freezing temperatures to block nerves, guided by magnetic resonance neurography.
Eligible Conditions
- Pelvic Pain Syndrome
- Inguinal Pain
- Lower Back Pain
- Perineal Neuralgia
- Meralgia Paresthetica
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Week 12
Change in self-reported average pain score
Month 18
Change in Self-Assessment of Treatment as assessed by a 5-item questionnaire
Change in analgesic medication use
Change in pain intensity as assessed by the Brief Pain Inventory (BPI)
Change in pain interference as assessed by the BPI
Change in percentage pain relief
Trial Safety
Trial Design
1 Treatment Group
Pelvic pain syndromes
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: MR neurography-guided cryoanalgesia · No Placebo Group · N/A
Pelvic pain syndromes
Device
Experimental Group · 1 Intervention: MR neurography-guided cryoanalgesia · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,076 Previous Clinical Trials
31,020,143 Total Patients Enrolled
BTG International Inc.OTHER
41 Previous Clinical Trials
3,194 Total Patients Enrolled
Jan Fritz, M.DPrincipal InvestigatorJohns Hopkins University
Eligibility Criteria
Age 18 - 100 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:old
People between the ages of 18 and 100 years old.
Chronic pelvic pain that doesn't improve with standard treatments like medication, physical therapy, and nerve blocks may be caused by a problem with the nervous system.
The person must report the pain to be at a 4 or higher on a scale of 0 to 10.
This means that the nerve can be frozen using MRI guidance.
The patient's pain must be due to a single lumbosacral nerve, as confirmed by selective nerve blocks that provide adequate temporary pain relief
with heparin
People with known coagulopathy or bleeding disorders are treated with heparin in order to control their condition.
care
No medical or psychiatric illness that would prevent giving consent or receiving treatment.
Cryoablation should be performed within 3 months of the nerve block.
Who else is applying?
What state do they live in?
| Maryland | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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