Clinical trial NCT05501262: Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morton Neuroma
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in quality of life
timeFrame: 1 year post procedure
measure: Réponse in pain
timeFrame: 1 year post procedure
measure: Changes to function
timeFrame: 1 year post procedure
measure: Changes pain and function due to neuroma
timeFrame: 1 year post procedure
measure: Incidence of Treatment - Emergent Adverse Events
timeFrame: 1 year post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Claire Kaufman
role: PRINCIPAL_INVESTIGATOR
References: