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

Study Overview
=================
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.

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

Conditions
-----------------
Morton Neuroma

Intervention / Treatment
-----------------
* Device: Cryoablation
* Procedure: Nerve block


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Steroid and lidocaine injection | Procedure: Nerve block<br>* Ultrasound and fluoroscopic guided nerve block.<br>|
| Experimental: Study<br>Steroid and lidocaine injection with cryoablation | Device: Cryoablation<br>* Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life | Will be evaluated using the SF-36 Quality of Life Survey | 1 year post procedure | 
| Réponse in pain | Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable | 1 year post procedure | 
| Changes to function | Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic | 1 year post procedure | 
| Changes pain and function due to neuroma | Changes in Neuroma Scale, higher score is less symptomatic | 1 year post procedure | 
| Incidence of Treatment - Emergent Adverse Events | Monitoring for safety of the treatment arm | 1 year post procedure |