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Trial Title:
Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
NCT ID:
NCT05501262
Condition:
Morton Neuroma
Conditions: Official terms:
Neuroma
Morton Neuroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Cryoablation
Description:
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's
neuroma after nerve block.
Arm group label:
Study
Intervention type:
Procedure
Intervention name:
Nerve block
Description:
Ultrasound and fluoroscopic guided nerve block.
Arm group label:
Standard of Care
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
105 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Oregon Health Sciences University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lori Russell
Start date:
July 25, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
Oregon Health and Science University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05501262