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Cryoablation vs Steroid Injections for Morton's Neuroma
N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post procedure
Awards & highlights
Summary
This trial is testing cryoablation, a treatment that uses extreme cold to destroy nerve tissue, on middle-aged women with Morton's neuroma who haven't found relief from other treatments. The goal is to see if this method is more effective than steroid injections in reducing pain. Cryoablation is a specialized technique for providing long-term pain relief and has been used in various medical fields since its development in 1961.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in quality of life
Changes pain and function due to neuroma
Changes to function
+2 moreSide effects data
From 2022 Phase 2 trial • 30 Patients • NCT0411816650%
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%
Abdominal bloating
7%
Headache
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%
Neuropathy under R axilla
3%
Worsening cough
3%
Worsening anxiety
3%
Right pleural effusion
3%
Intermittent chills followed by hot flashes
3%
UTI
3%
Muscle and joint aches
3%
Confusion
3%
Allergic reaction
3%
Other, Motor deficit, left side
3%
Muscle weakness, left-sided
3%
Intermittent brief blurry vision
3%
Worsening left leg weakness
3%
Other, Motor deficit, right side
3%
Intermittent abdominal bloating
3%
Gum infection
3%
Other, Infectious diarrhea
3%
Arthralgias
3%
Dizziness
3%
Muscle weakness, right-sided
3%
Anxiety
3%
Insomnia
3%
Pneumothorax
3%
Hiccups
3%
Lower back throbbing pain
3%
Pneumonitis
3%
Nasal congestion
3%
Other, Lack of appetite
3%
Right apical pneumothorax
3%
Pain
3%
Other, Intermittent left sciatic pain
3%
Shortness of breath with exertion
3%
Hoarse voice
3%
L eye pain
3%
Other, Intermittent bilateral hand numbness
3%
Pleural effusion
3%
Other, Corneal abrasion
3%
L eye redness
3%
Right neck pain
3%
Right pneumothorax
3%
Arthritis
3%
Muscle weakness
3%
Right shoulder pain (Pain in extremity)
3%
Peripheral sensory neuropathy
3%
Respiratory failure
3%
Chest wall pain
3%
Other, Neuropathic pain
3%
Other, Occasional twitching sensation to anterior chest wall
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
2017
Completed Phase 2
~1030
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Morton's Neuroma is commonly treated with cryoablation and corticosteroid injections. Cryoablation involves freezing the nerve tissue, which disrupts the nerve's ability to transmit pain signals, providing relief from the burning or shooting pain associated with the condition.
This method is particularly relevant for patients who have not responded to conservative treatments like orthotics. Corticosteroid injections, on the other hand, reduce inflammation and swelling around the nerve, which can alleviate pain but often only provides short-term relief.
Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, especially when considering the long-term efficacy and potential side effects.
Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients.
Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
996 Previous Clinical Trials
7,387,648 Total Patients Enrolled
Claire KaufmanPrincipal InvestigatorOregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another medical condition that could explain the symptoms found on imaging tests.You are older than 18 years.You should not have a medical condition that makes cryoablation or lidocaine/steroid injection unsafe for you.You have tried using special shoe inserts, proper shoes, and/or metatarsal pads for four weeks, but they did not help.You had an X-ray and ultrasound to confirm the presence and location of a Morton's neuroma, and no other issues were found.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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