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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 belowSelect...
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 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
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 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%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- X-ray and ultrasound tests show that you have a Morton's neuroma and not any other foot problems.You have already tried using orthotics, special shoes, or metatarsal pads for at least four weeks without success.You are older than 18 years.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.
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
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