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临床试验/NCT05501262
NCT05501262招募中不适用

Comparative Effectiveness of Cryoablation Using the ICE-Seed Cryoablation Needle With Steroid and Lidocaine Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
2
主要终点
Incidence of Treatment - Emergent Adverse Events

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Incidence of Treatment - Emergent Adverse Events

时间窗: 1 year post procedure

Monitoring for safety of the treatment arm

Réponse in pain

时间窗: 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

时间窗: 1 year post procedure

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

Changes pain and function due to neuroma

时间窗: 1 year post procedure

Changes in Neuroma Scale, higher score is less symptomatic

Changes to function

时间窗: 1 year post procedure

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claire Kaufman

Principal Investigator

Oregon Health and Science University

研究点 (2)

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