Morton Neuroma
Conditions
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.
Interventions
DEVICECryoablation
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.
PROCEDURENerve block
Ultrasound and fluoroscopic guided nerve block.
Sponsors
Boston Scientific Corporation
Society of Interventional Radiology Foundation
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life | 1 year post procedure | Will be evaluated using the SF-36 Quality of Life Survey |
| Réponse in pain | 1 year post procedure | Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable |
| Changes to function | 1 year post procedure | Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic |
| Changes pain and function due to neuroma | 1 year post procedure | Changes in Neuroma Scale, higher score is less symptomatic |
| Incidence of Treatment - Emergent Adverse Events | 1 year post procedure | Monitoring for safety of the treatment arm |
Countries
United States
Contacts
Primary ContactLori L Russell, MSN BSN RN
Outcome results
None listed