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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-105
SponsorOregon Health and Science University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryoablation

    Device

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

  • Nerve block

    Procedure/Surgery

    Ultrasound and fluoroscopic guided nerve block.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: StudyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in quality of life

Will be evaluated using the SF-36 Quality of Life Survey

Time frame
1 year post procedure
2

Réponse in pain

Will be evaluated using the visual analog scale with 0 as no pain and 10 as the word pain imaginable

Time frame
1 year post procedure
3

Changes to function

Changes to the modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal--Interphalangeal Scale, higher score is less symptomatic

Time frame
1 year post procedure
4

Changes pain and function due to neuroma

Changes in Neuroma Scale, higher score is less symptomatic

Time frame
1 year post procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Boston Scientific Corporation

Collaborator

Society of Interventional Radiology Foundation

Collaborator