What side effects are associated with this type of intervention?

The most common treatments for Morton's Neuroma include corticosteroid injections, cryoablation, and surgical resection. Corticosteroid injections can provide short-term pain relief but have a long-term resolution rate of only 30% and may cause side effects such as pain at the injection site and potential weakening of the surrounding tissues. Cryoablation, which involves freezing the nerve tissue to reduce pain, has been shown to be safe and effective in small studies, with minimal side effects reported. Surgical resection has a higher success rate (51-85%) but carries risks of complications such as recurrent pain, numbness, loss of sensation, and the development of stump neuromas.

What prior FDA approvals exist?

Morton's Neuroma is commonly treated with conservative methods such as orthotics and steroid injections, which have limited long-term success rates. Surgical resection is another option but comes with a higher complication rate. Cryoablation, a technique that involves freezing nerve tissue to reduce pain, has shown promise in recent studies for treating Morton's Neuroma. However, there is no specific mention of FDA approvals for cryoablation in the provided context. The focus remains on its efficacy and safety as demonstrated in small studies, suggesting it as a potential alternative to more traditional treatments.

What other types of research exist?

Promising novel alternatives to cryoablation for Morton's Neuroma include ultrasound-guided percutaneous needle tenotomy, which involves fenestrating tendinotic tissue to promote healing, and iontophoresis, which uses electrical currents to deliver anti-inflammatory medications like dexamethasone. Both methods have shown potential benefits in preliminary studies and may offer effective pain relief.

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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

No Placebo-Only Group

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

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

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 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%

Dyspnea

10%

Productive cough

10%

Hyperthyroidism

10%

Diarrhea

10%

Other, Decreased appetite

Abdominal bloating

Headache

Elevated ALT

Elevated AST

Intermittent heart palpitations

Tachycardia

Dry mouth

Intermittent nausea

Hyponatremia

Other, Pain to right chest wall at recent site of cryo

Wheezing

Nasal congestion

Dizziness

UTI

Other, Lack of appetite

Allergic reaction

Neuropathy under R axilla

Other, Motor deficit, right side

L eye pain

Hiccups

Pain

Other, Intermittent left sciatic pain

Intermittent brief blurry vision

Intermittent chills followed by hot flashes

Gum infection

Anxiety

Insomnia

Muscle weakness

Other, Motor deficit, left side

Pneumonitis

Right neck pain

Worsening anxiety

Other, Neuropathic pain

Pneumothorax

Hoarse voice

Peripheral sensory neuropathy

Muscle weakness, left-sided

Respiratory failure

Arthralgias

Other, Corneal abrasion

L eye redness

Confusion

Other, Intermittent bilateral hand numbness

Muscle and joint aches

Lower back throbbing pain

Right shoulder pain (Pain in extremity)

Pleural effusion

Arthritis

Right pleural effusion

Shortness of breath with exertion

Chest wall pain

Muscle weakness, right-sided

Other, Infectious diarrhea

Right apical pneumothorax

Intermittent abdominal bloating

Worsening cough

Worsening left leg weakness

Other, Occasional twitching sensation to anterior chest wall

Right pneumothorax

Chest Pain

Keratitis

Tension pneumothorax (requiring ICU stay)

Depression

Sore throat

Cardiac arrest

Adrenal insufficiency

Blood bilirubin increased

Alkaline phosphatase increased

Hematuria

Proteinuria

Intermittent bronchopulmonary hemorrhage

Shortness of breath

Hypoxia

Other, Deep vein thrombois (DVT) of catheter

Atrial fibrillation

Pericarditis

Sinus tachycardia

Other, Decreased pulse

Ringing in the ears (tinnitus)

Hypophysitis

Dry eyes

Flashing lights

L eye burning sensation

L eye blurred vision

R eye blurred vision

Increased abdominal pain

Diarrhea (intermittent)

Intermittent nausea/vomiting

Vomiting

Other, Mucositis

Intermittent fever

Low grade fever

Flu-like symptoms

Intermittent chest pain to R sternal border exacerbated with deep inhalation

Intermittent fatigue

Other, Presumed pneumonia

Fall

Creatinine increased

Elevated TSH

TSH increased

Decreased WBC count

Anorexia

Other, Gluteal pain and swelling

Other, Arm pain left

Other, Muscle aches and fatigue associated with COVID vaccine

Other, Right thigh pain

Other, Soreness to right lateral ribs

Other, Soreness at site of recent cryoablation (R lung)

Other, Soreness right chest wall

Other, Soreness to left side at site of recent cryoablation

Other, Soreness, right shoulder

Other, Pelvic bone pain

Other, Intermittent peripheral edema

Other, Weakness to left shoulder

Intermittent hematuria

Blood tinge sputum

Intermittent cough

Intermittent cough w/chest tightness

Intermittent cough with Blood tinge sputum

Dry cough

Other, Hair thinning

Other, Leg ulcer left

Other, Molluscum contagiousum on left arm

Pulmonary embolism

Upper respiratory infection (COVID-19)

Intermittent wheezing

Other, Hemoptysis

Dry skin

Facial rash

Maculo-papular rash

Maculo-papular rash to bilateral arms

Post-inflammatory hyperpigmentation on left breast

Tinea

Other, Burned hand

100%

80%

60%

40%

20%

Study treatment Arm

Ipilimumab/Nivolumab + Cryotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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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.