Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma

NCT05604144 | Unknown FDA Device

• 1 other identifier: IITMN001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.

Conditions

Morton's Neuroma; Pain Management

Keywords

Proof-of-Concept; Pilot Study; Podiatric Pain Management; Cryoanalgesia

Outcome Measures

Primary Outcomes (1)

• Pain Management

  Numeric Rating Scale (NRS) Pain Intensity Scores completed by subjects three times per day from Day 0 to 3 months post treatment, then NRS weekly through 6 months post treatment. 2. The total daily opioid consumption from Day 0 to 6 months post treatment.

  Six Months

Secondary Outcomes (3)

• Adverse Events and Serious Adverse Events

  Six Months

• Ambulation

  Six Months

• Medical Device Feasibility

  Six Months

Study Arms (1)

Active Treatment

OTHER

As a Proof of Concept Study, 5 subjects will follow the same protocol, with one cryoanalgesic treatment (iovera°®) with a 6 month clinical follow-up.

Device: Cryoanalgesia (iovera°®)

Interventions

Cryoanalgesia (iovera°®) DEVICE

iovera°® treatment will be administered via ultrasound guidance to 1-2 branches of the dorsal/digital/proper nerve/s that innervate the Morton's neuroma. The treatment will be completed one time per subject.

Also known as: iovera°®

Active Treatment

Eligibility Criteria

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

You may qualify if:

• Healthy adult male or female volunteers ages 18 or older.
• Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
• Body Mass Index (BMI) ≥18 and ≤40 kg/m2.
• Unilateral Morton's Neuroma diagnosed by MRI.
• Subject has failed conservative treatment options.

You may not qualify if:

• Documented allergy, hypersensitivity, intolerance, or contraindication to amide-type local anesthetics (i.e., lidocaine), or opioids, NSAIDs.
• Documented history of uncontrolled diabetes, bleeding disorder, severe Peripheral Vascular Disease (PVD).
• Concurrent painful physical condition that may require analgesic treatment (i.e., long-term opioid use) which, in the Principal Investigator's opinion, may confound the treatment assessments.
• History of, suspected, or known addiction to/or abuse of illicit drug/s, prescription medicine/s, or alcohol within the past 3 years.
• Administration of an investigational drug or medical device within 30 days of the Screening Period.
• Previous participation in a cryoneurolysis study.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Principal Investigator, could potentially interfere with study assessments or compliance.
• Currently pregnant, nursing, or planning to become pregnant during the study.
• Clinically significant medical disease that, in the opinion of the Principal Investigator, would make participation in a clinical study inappropriate.
• Inadequate sensory function of the affected foot (as defined at the Screening Visit Neurologic Lower Extremity (LE) exams).
• Any clinically significant event or condition uncovered during the Screening Period (e.g., contra-lateral foot injury) that, in the opinion of the Principal Investigator, renders the subject medically unstable or complicates the subject's study participation.
• Subject has a history of: Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria or Raynaud's Disease.
• Subject has an active, wound, open and/or potential infection near the anticipated treatment site.

Sponsors & Collaborators

• Northern California Research Trials, Inc.: lead
• Pacira Pharmaceuticals, Inc: collaborator
• NorthBay Healthcare: collaborator

Study Sites (2)

NorthBay Healthcare

Fairfield, California, 94534, United States

Location

NorthBay Healthcare

Vacaville, California, 95687, United States

Location

Related Publications (10)

• Cleveland Clinic Communication: Morton's Neuroma: Causes, Symptoms, Diagnois & Treatment. https://my.cleveland clinic.org/health/diseases/15118-mortons-neuroma pages 1-13.

  BACKGROUND

• Matthews BG, Hurn SE, Harding MP, Henry RA, Ware RS. The effectiveness of non-surgical interventions for common plantar digital compressive neuropathy (Morton's neuroma): a systematic review and meta-analysis. J Foot Ankle Res. 2019 Feb 13;12:12. doi: 10.1186/s13047-019-0320-7. eCollection 2019.

  PMID: 30809275 BACKGROUND

• Sidon E, Rogero R, McDonald E, Daecher A, Shakked R, Pedowitz DI, Fuchs D, Daniel JN, Raikin SM. Prevalence of Neuropathic Pain Symptoms in Foot and Ankle Patients. Foot Ankle Int. 2019 Jun;40(6):629-633. doi: 10.1177/1071100719838302. Epub 2019 Mar 22.

  PMID: 30902025 BACKGROUND

• Thomson L, Aujla RS, Divall P, Bhatia M. Non-surgical treatments for Morton's neuroma: A systematic review. Foot Ankle Surg. 2020 Oct;26(7):736-743. doi: 10.1016/j.fas.2019.09.009. Epub 2019 Nov 2.

  PMID: 31718949 BACKGROUND

• Ferkel E, Davis WH, Ellington JK. Entrapment Neuropathies of the Foot and Ankle. Clin Sports Med. 2015 Oct;34(4):791-801. doi: 10.1016/j.csm.2015.06.002.

  PMID: 26409596 BACKGROUND

• Ross AB, Jacobs A, Williams KL, Bour RK, Gyftopoulos S. Ultrasound-Guided Injection Treatments Versus Surgical Neurectomy for Morton Neuroma: A Cost-Effectiveness Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):234-240. doi: 10.2214/AJR.21.26419. Epub 2021 Sep 15.

  PMID: 34523955 BACKGROUND

• Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

  PMID: 28336454 BACKGROUND

• Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.

  PMID: 26875052 BACKGROUND

• Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

  PMID: 29095245 BACKGROUND

• Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.

  PMID: 29189515 BACKGROUND

MeSH Terms

Conditions

Morton Neuroma; Agnosia

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Kevin M Miller, DPM, FACPM, FFPM

  NorthBay Healthcare

  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

Model Details: Proof-of-Concept

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: November 3, 2022
• Study Start: August 22, 2022
• Primary Completion: April 22, 2023
• Study Completion: April 22, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)