Pelvic Pain Treated With MR-guided Cryoanalgesia

NCT04046406 | Withdrawn FDA Device

• 1 other identifier: IRB00222178
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Pelvic Pain Syndrome; Groin Pain; Meralgia Paresthetica; Low Back Pain; Perineal Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in pain intensity as assessed by the Brief Pain Inventory (BPI)

  Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

• Change in percentage pain relief

  Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

• Change in analgesic medication use

  Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

• Change in pain interference as assessed by the BPI

  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

  Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

Study Arms (1)

Pelvic pain syndromes

EXPERIMENTAL

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

Device: MR neurography-guided cryoanalgesia

Interventions

MR neurography-guided cryoanalgesia DEVICE

Treatment will be performed using a FDA-approved Galil Medical cryoablation system and FDA-approved Galil Medical cryoablation needles.

Pelvic pain syndromes

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• BTG International Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Femoral Neuropathy; Low Back Pain; Neuralgia

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Fritz, M.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: November 13, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)