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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05501262
Status
Recruiting
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Conditions

  • Morton Neuroma

Eligibility Criteria

Sex
ALL
Age
18 Years - 105 Years
Healthy Volunteers
Accepted

Interventions

  • Cryoablation — DEVICE
    Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block.
  • Nerve block — PROCEDURE
    Ultrasound and fluoroscopic guided nerve block.

Study Details

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.

Key Dates

Start date
Jul 25, 2022
Status verified
Oct 2025
Primary completion
Dec 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Steroid and lidocaine injection
  • Experimental: Study
    Steroid and lidocaine injection with cryoablation

Primary Outcome Measure

Changes in quality of life [ Time Frame: 1 year post procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health Sciences UniversityPortlandOregon97239
Lori Russell

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Oregon Health Sciences University· Portland, OR

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