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

Not Applicable

• Conditions: Morton Neuroma
• Interventions: Device: Cryoablation; Procedure: Nerve block

• Registration Number: NCT05501262
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-25
• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-15
• Primary Completion: 2023-07-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	Cryoablation	Steroid and lidocaine injection with cryoablation
Standard of Care	Nerve block	Steroid and lidocaine injection

Primary Outcome Measures

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

Trial Locations

Locations (1)

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States