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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Society of Interventional Radiology Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Steroid and lidocaine injection |
|
| Study | Experimental | Steroid and lidocaine injection with cryoablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life | Will be evaluated using the SF-36 Quality of Life Survey | 1 year post procedure |
| 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 |
| 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 |
| Changes pain and function due to neuroma | Changes in Neuroma Scale, higher score is less symptomatic | 1 year post procedure |
| Incidence of Treatment - Emergent Adverse Events | Monitoring for safety of the treatment arm | 1 year post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori L Russell, MSN BSN RN | Contact | 503-494-7226 | watsonlo@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Claire Kaufman | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
Anonymized data may be shared with other researchers via a secure web based portal.
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| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
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| Nerve block | Procedure | Ultrasound and fluoroscopic guided nerve block. |
|
| D009437 |
| Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000760 |
| Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |