Pelvic Pain Treated With MR-guided Cryoanalgesia

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, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation can induce long-lasting nerve conduction blocks with resultant pain relief for several months. The objective of this study is to evaluate the effectiveness of magnetic resonance (MR) neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain; Groin Pain; Pelvic Pain Syndrome; Meralgia Paresthetica; Perineal Neuralgia
• Intervention / Treatment: Device: MR neurography-guided cryoanalgesia

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), genitofemoral nerve (GFN), ilioinguinal nerve (IIN), iliohypogastric nerve (IHN), pudendal nerve (PN), obturator nerve (ON), posterior femoral cutaneous nerve (PFCN), and others, have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery, including episiotomy, orthopedic instrumentation and surgical hernia repair. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation of sensory nerves at temperatures of approximately 40 degrees Celsius and below (Cryoanalgesia) can induce long-lasting nerve conduction blocks with resultant pain relief for several months, which could be an effective treatment option for a large number of patients in this group before, instead of, and after failed surgical treatment. Cryoablation affords several advantages over other thermal or chemical ablation techniques, including direct visualization of the ablation zone, decreased intraprocedural and postprocedural pain, and the ability to simultaneously use multiple probes in variable configurations to create tailored additive overlapping ablation zones. In contrast to surgical or heat-mediated ablation, cryoablation does not disrupt the acellular epineurium or perineurium, which reduces the risk of neuroma formation and may allow eventual nerve regeneration, after which the cryoanalgesia can be repeated. Interventional MR neurography at 3 Tesla describes the combined use of high-resolution MRI for the visualization of smallest nerves that are located deep inside the pelvis, targeting, placement of needles and probes, and process monitoring, such as growth of the ice ball and relationship to the target nerves. The use of interventional MR neurography is thus ideally suited to perform cryoanalgesia with the highest technical accuracy and safety. The objective of this study is to evaluate the effectiveness of MR neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic pain syndromes; Patients with pelvic pain syndromes who will undergo MR neurography-guided cryoanalgesia	Device: MR neurography-guided cryoanalgesia; Treatment will be performed using a FDA-approved Galil Medical cryoablation system and FDA-approved Galil Medical cryoablation needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported average pain score	Therapeutic success is defined as 50 percent or more pain reduction and/or an absolute pain level below 2 on an 11-point visual analog pain scale of 0 (no pain) to 10 (pain as bad as subject can imagine).	Baseline and 12 weeks post cryoablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity as assessed by the Brief Pain Inventory (BPI)	This test will assess pain intensity (worst pain, least pain, average pain, pain right now) measured on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine).	Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in percentage pain relief	This test will assess percentage pain relief since baseline on an 11-point visual analogue scale with 10 percent increments with higher scores indicating more relief.	Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in analgesic medication use	This test will assess analgesic medication use in order to assess change in analgesic medications by recording the daily dose and type of medication. Morphine Equivalent Daily Dosing and Comparable NSAID Dose Levels will be used to compare the dose of different pain medications.	Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in pain interference as assessed by the BPI	This test will assess pain interference using a 7-item questionnaire on the BPI (that includes general activity, mood, walking ability, normal walk, relations with other people, sleep, and enjoyment of life) scored on an 11-point visual analogue scale from 0 to 10 with 0 meaning no interference and 10 meaning complete interference.	Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Change in Self-Assessment of Treatment as assessed by a 5-item questionnaire	The change in the self-assessment of the treatment offered patients will be assessed with a 5-item questionnaire that is graded on a 5-point Likert scale which ranges from -2 to +2 with positive scores indicating better satisfaction with treatment.	Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: BTG International Inc.
• Investigators: Principal Investigator: Jan Fritz, M.D, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Neuralgia; Pelvic Pain; Femoral Neuropathy
• Other Study ID Numbers: IRB00222178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes