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

Primary Purpose

Morton Neuroma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryoablation
Nerve block
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morton Neuroma

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Health Sciences UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Study

Arm Description

Steroid and lidocaine injection

Steroid and lidocaine injection with cryoablation

Outcomes

Primary Outcome Measures

Changes in quality of life
Will be evaluated using the SF-36 Quality of Life Survey
Réponse in pain
Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable
Changes to function
Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic
Changes pain and function due to neuroma
Changes in Neuroma Scale, higher score is less symptomatic
Incidence of Treatment - Emergent Adverse Events
Monitoring for safety of the treatment arm

Secondary Outcome Measures

Full Information

First Posted
August 8, 2022
Last Updated
August 11, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05501262
Brief Title
Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morton Neuroma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Steroid and lidocaine injection
Arm Title
Study
Arm Type
Experimental
Arm Description
Steroid and lidocaine injection with cryoablation
Intervention Type
Device
Intervention Name(s)
Cryoablation
Intervention Description
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.
Intervention Type
Procedure
Intervention Name(s)
Nerve block
Intervention Description
Ultrasound and fluoroscopic guided nerve block.
Primary Outcome Measure Information:
Title
Changes in quality of life
Description
Will be evaluated using the SF-36 Quality of Life Survey
Time Frame
1 year post procedure
Title
Réponse in pain
Description
Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable
Time Frame
1 year post procedure
Title
Changes to function
Description
Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic
Time Frame
1 year post procedure
Title
Changes pain and function due to neuroma
Description
Changes in Neuroma Scale, higher score is less symptomatic
Time Frame
1 year post procedure
Title
Incidence of Treatment - Emergent Adverse Events
Description
Monitoring for safety of the treatment arm
Time Frame
1 year post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dotter Interventional Institute
Phone
(503) 418-6725
Email
watsonlo@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Kaufman
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Russell

12. IPD Sharing Statement

Learn more about this trial

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

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