Status:
WITHDRAWN
Pelvic Pain Treated With MR-guided Cryoanalgesia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
BTG International Inc.
Conditions:
Pelvic Pain Syndrome
Groin Pain
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Pelvic pain syndromes have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery. While medical management is the initial therapeutic step, i...
Detailed Description
Pelvic pain syndromes including meralgia paresthetica, inguinodynia, and deep gluteal syndrome and others, which are caused by nerves including the the lateral femoral cutaneous nerve (LFCN), genitofe...
Eligibility Criteria
Inclusion
- 18 to 100 years
- Chronic pelvic pain for at least 3 months and no adequate pain relief defined as persistent worst pain 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite conservative treatments, including but not limited to oral pain medication including NSAIDs and narcotics, physical therapy, and nerve block.
- The 'worst pain' must be reported to be 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine)
- 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.
- The target nerve is amenable to cryoablation with MRI guidance
- Cryoablation should be performed within 3 months of the nerve block
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- Known coagulopathy or bleeding disorders are controlled
Exclusion
- Confounding pain syndromes or conditions.
- Previous nerve surgery
- 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
- Concurrent participation in other studies that could affect the primary endpoint
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04046406
Start Date
November 13 2019
End Date
January 1 2023
Last Update
April 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287