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

Morton Neuroma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501262
• Other study ID #: STUDY00024090
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Oregon Health and Science University
• Contact: Dotter Interventional Institute
• Phone: (503) 418-6725
• Email: watsonlo[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Morton Neuroma
• Neuroma

Intervention

Device:
• Cryoablation
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.

Procedure:
• Nerve block
Ultrasound and fluoroscopic guided nerve block.

Locations

Country	Name	City	State
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quality of life	Will be evaluated using the SF-36 Quality of Life Survey	1 year post procedure
Primary	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
Primary	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
Primary	Changes pain and function due to neuroma	Changes in Neuroma Scale, higher score is less symptomatic	1 year post procedure
Primary	Incidence of Treatment - Emergent Adverse Events	Monitoring for safety of the treatment arm	1 year post procedure