2024-513609-29-01招募中4 期
Prospective, randomized, blinded, comparative study between botulinum toxin and topical capsaicin in the treatment of postmastectomy syndrome. Pilot study
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月4日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain assessment: Recording of pain intensity using a visual analogue scale (VAS)
研究概览
简要总结
To determine the effectiveness of Botulinum Toxin type A and topical Capsaicin for the treatment of moderate-severe pain in PMS among women who underwent surgery for unilateral breast neoplasia.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years of age operated on for unilateral breast neoplasia
- •Patients with painful symptoms defining postmastectomy syndrome.
- •Patients with moderate-severe pain.
- •Signed informed consent form.
排除标准
- •Age less than 18 years
- •Presence of cognitive-behavioral deficits.
- •Patients with bilateral tumor involvement, cases of tumor recurrence, patients referred for non-oncologic breast surgery.
- •Non-acceptance to participate in the study.
- •Breast tumors in men.
结局指标
主要结局
Pain assessment: Recording of pain intensity using a visual analogue scale (VAS)
Pain assessment: Recording of pain intensity using a visual analogue scale (VAS)
Characterization of the predominant pain perception: burning, stabbing pain, sensation of pressure or numbness.
Characterization of the predominant pain perception: burning, stabbing pain, sensation of pressure or numbness.
次要结局
- Recording of side effects
- Recording of the degree of patient satisfaction
- Recording of concomitant analgesic medications
研究者
M Rosario Beseler Soto
Scientific
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
研究点 (1)
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