Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma

Sponsor
Oregon Health and Science University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05501262
Collaborator
(none)
32
1
2
17.2
1.9

Study Details

Study Description

Brief Summary

Morton's neuroma is a benign thickening involving the plantar interdigital nerve, most common in middle aged women. Morton's neuroma is one of the most frequent diagnoses seen in the investigators podiatry clinic and is difficult to treat. These lesions cause a burning or shooting pain that can radiate to the toes, or an aching pain in the ball of the foot. The pain is exacerbated with activity and certain footwear greatly limits activity in the involved patient population. Morton's neuroma is first treated conservatively with orthotics. Patients may require further interventions such as steroid injections. The literature reports only a 30% long term resolution of pain with the steroid. Surgical resection has a reported 51-85% success rate with 14-21% rate of complication; recurrent pain, numbness/loss of sensation, and subsequent stump neuromas.

Cryoablation is well known to be efficacious for neuropathic pain and has recently been shown in two small studies to be safe and efficacious for treatment of Morton's neuroma. The investigators study will compare outcomes of cryoablation to corticosteroid injection in short- and long-term for treatment of Morton's neuroma that have failed conservative therapy.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryoablation
  • Procedure: Nerve block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparative Effectiveness of Cryoablation Using the ICE-Seed Cryoablation Needle With Steroid and Lidocaine Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard of Care

Steroid and lidocaine injection

Procedure: Nerve block
Ultrasound and fluoroscopic guided nerve block.

Experimental: Study

Steroid and lidocaine injection with cryoablation

Device: Cryoablation
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.

Outcome Measures

Primary Outcome Measures

  1. Changes in quality of life [1 year post procedure]

    Will be evaluated using the SF-36 Quality of Life Survey

  2. RĂ©ponse in pain [1 year post procedure]

    Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable

  3. Changes to function [1 year post procedure]

    Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic

  4. Changes pain and function due to neuroma [1 year post procedure]

    Changes in Neuroma Scale, higher score is less symptomatic

  5. Incidence of Treatment - Emergent Adverse Events [1 year post procedure]

    Monitoring for safety of the treatment arm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age >18 years

  • Able to consent and complete questionnaires

  • Failure of a four-week trial of conservative therapy (includes orthotics, appropriate footwear, and/or metatarsal pads)

  • X-ray and ultrasound excluding other pathology and confirming the presence and location of a Morton's neuroma

Exclusion Criteria:
  • Inability to follow-up or to comply with the follow-up protocol

  • Contraindication to cryoablation and/or lidocaine/steroid injection

  • Other pathology which could account for symptoms identified on imaging studies

  • Unwillingness to be randomized

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health Sciences University Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University

Investigators

  • Principal Investigator: Claire Kaufman, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT05501262
Other Study ID Numbers:
  • STUDY00024090
First Posted:
Aug 15, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022