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Cryoablation vs Steroid Injections for Morton's Neuroma

N/A
Recruiting
Led By Claire Kaufman
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Failure of a four-week trial of conservative therapy (includes orthotics, appropriate footwear, and/or metatarsal pads)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post procedure
Awards & highlights

Study Summary

This trial is studying whether cryoablation (freezing the nerve) is better than a corticosteroid injection for treating Morton's neuroma.

Who is the study for?
This trial is for adults over 18 who have Morton's neuroma, a painful foot condition, and haven't improved after four weeks of non-surgical treatments like orthotics. Participants must be able to consent and complete surveys. Those with other foot issues on imaging or unable to follow the study plan can't join.Check my eligibility
What is being tested?
The study compares two treatments for Morton's neuroma: cryoablation (freezing nerves) and steroid injections combined with lidocaine (a numbing agent). It aims to see which method better relieves pain in the short and long term after conservative methods fail.See study design
What are the potential side effects?
Cryoablation may cause temporary discomfort, skin changes at the treatment site, or nerve damage. Steroid injections might lead to fat tissue thinning under the skin, color changes in the skin, increased blood sugar levels in diabetics, or tendon weakening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are older than 18 years.
Select...
You have tried using special shoe inserts, proper shoes, and/or metatarsal pads for four weeks, but they did not help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in quality of life
Changes pain and function due to neuroma
Changes to function
+2 more

Side effects data

From 2022 Phase 2 trial • 30 Patients • NCT04118166
50%
Other, Disease Progression (death)
30%
Fatigue
23%
Cough
17%
Constipation
17%
Nausea
17%
Pruritis
13%
Anemia
13%
Hypothyroidism
13%
Abdominal pain
13%
Fever
13%
Weight loss
13%
Rash
10%
Productive cough
10%
Dyspnea
10%
Hyperthyroidism
10%
Diarrhea
10%
Other, Decreased appetite
7%
Headache
7%
Abdominal bloating
7%
Elevated ALT
7%
Elevated AST
7%
Intermittent heart palpitations
7%
Tachycardia
7%
Dry mouth
7%
Intermittent nausea
7%
Hyponatremia
7%
Other, Pain to right chest wall at recent site of cryo
7%
Wheezing
3%
L eye redness
3%
Pneumothorax
3%
Pneumonitis
3%
Other, Infectious diarrhea
3%
Peripheral sensory neuropathy
3%
Worsening anxiety
3%
Allergic reaction
3%
Confusion
3%
Nasal congestion
3%
Right pneumothorax
3%
Dizziness
3%
Muscle and joint aches
3%
Other, Intermittent bilateral hand numbness
3%
Hoarse voice
3%
Worsening left leg weakness
3%
Pleural effusion
3%
Insomnia
3%
Chest wall pain
3%
Arthralgias
3%
Muscle weakness, left-sided
3%
Gum infection
3%
UTI
3%
Other, Neuropathic pain
3%
Right pleural effusion
3%
Respiratory failure
3%
Right neck pain
3%
L eye pain
3%
Other, Motor deficit, right side
3%
Other, Lack of appetite
3%
Intermittent brief blurry vision
3%
Other, Corneal abrasion
3%
Muscle weakness
3%
Neuropathy under R axilla
3%
Worsening cough
3%
Other, Intermittent left sciatic pain
3%
Anxiety
3%
Hiccups
3%
Arthritis
3%
Muscle weakness, right-sided
3%
Other, Motor deficit, left side
3%
Other, Occasional twitching sensation to anterior chest wall
3%
Right apical pneumothorax
3%
Pain
3%
Intermittent chills followed by hot flashes
3%
Lower back throbbing pain
3%
Shortness of breath with exertion
3%
Right shoulder pain (Pain in extremity)
3%
Intermittent abdominal bloating
3%
Chest Pain
3%
Keratitis
3%
Tension pneumothorax (requiring ICU stay)
3%
Depression
3%
Sore throat
3%
Cardiac arrest
3%
Adrenal insufficiency
3%
Blood bilirubin increased
3%
Alkaline phosphatase increased
3%
Hematuria
3%
Proteinuria
3%
Intermittent bronchopulmonary hemorrhage
3%
Shortness of breath
3%
Hypoxia
3%
Other, Deep vein thrombois (DVT) of catheter
3%
Atrial fibrillation
3%
Pericarditis
3%
Sinus tachycardia
3%
Other, Decreased pulse
3%
Ringing in the ears (tinnitus)
3%
Hypophysitis
3%
Dry eyes
3%
Flashing lights
3%
L eye burning sensation
3%
L eye blurred vision
3%
R eye blurred vision
3%
Increased abdominal pain
3%
Diarrhea (intermittent)
3%
Intermittent nausea/vomiting
3%
Vomiting
3%
Other, Mucositis
3%
Intermittent fever
3%
Low grade fever
3%
Flu-like symptoms
3%
Intermittent chest pain to R sternal border exacerbated with deep inhalation
3%
Intermittent fatigue
3%
Other, Presumed pneumonia
3%
Fall
3%
Creatinine increased
3%
Elevated TSH
3%
TSH increased
3%
Decreased WBC count
3%
Anorexia
3%
Other, Gluteal pain and swelling
3%
Other, Arm pain left
3%
Other, Muscle aches and fatigue associated with COVID vaccine
3%
Other, Right thigh pain
3%
Other, Soreness to right lateral ribs
3%
Other, Soreness at site of recent cryoablation (R lung)
3%
Other, Soreness right chest wall
3%
Other, Soreness to left side at site of recent cryoablation
3%
Other, Soreness, right shoulder
3%
Other, Pelvic bone pain
3%
Other, Intermittent peripheral edema
3%
Other, Weakness to left shoulder
3%
Intermittent hematuria
3%
Blood tinge sputum
3%
Intermittent cough
3%
Intermittent cough w/chest tightness
3%
Intermittent cough with Blood tinge sputum
3%
Dry cough
3%
Other, Hair thinning
3%
Other, Leg ulcer left
3%
Other, Molluscum contagiousum on left arm
3%
Pulmonary embolism
3%
Upper respiratory infection (COVID-19)
3%
Intermittent wheezing
3%
Other, Hemoptysis
3%
Dry skin
3%
Facial rash
3%
Maculo-papular rash
3%
Maculo-papular rash to bilateral arms
3%
Post-inflammatory hyperpigmentation on left breast
3%
Tinea
3%
Other, Burned hand
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ipilimumab/Nivolumab + Cryotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: StudyExperimental Treatment1 Intervention
Steroid and lidocaine injection with cryoablation
Group II: Standard of CareActive Control1 Intervention
Steroid and lidocaine injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~1050

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
966 Previous Clinical Trials
6,845,719 Total Patients Enrolled
Claire KaufmanPrincipal InvestigatorOregon Health and Science University

Media Library

Cryoablation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05501262 — N/A
Morton's Neuroma Research Study Groups: Standard of Care, Study
Morton's Neuroma Clinical Trial 2023: Cryoablation Highlights & Side Effects. Trial Name: NCT05501262 — N/A
Cryoablation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501262 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the numerical extent of participants in this trial?

"Affirmative. Information found on clinicaltrials.gov indicates that this research is actively seeking participants, having been posted on July 25th 2022 and updated most recently in August 11th 2022. At present, 32 individuals are being recruited at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Oregon Health Sciences University
What portion of applicants met pre-screening criteria?
Met criteria
~12 spots leftby Mar 2025