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临床试验/NCT02168244
NCT02168244已完成不适用

Reduction of Injection-related Pain Caused by Subcutaneous Administration of Biologic Drugs in Psoriasis

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Reduction of pain measured on a visual analogue scale

研究概览

简要总结

Injectable biologic drugs are used as a treatment of psoriasis. These injections can sometimes be associated with pain. In this study the investigators aim to reduce the pain by applying heat or ice to the skin 2-3 minutes before injecting the drug, and to compare the pain to injection without any heat or ice.

详细描述

As part of their therapy, some patients with psoriasis require treatment with biologic drugs, which are injected into their skin. While these are very effective, patients may experience some pain or discomfort associated with the injection of these drugs.

In this research study conducted at Mount Sinai hospital, the investigators aim to identify whether this injection-related pain can be reduced if the area of skin to be injected with the biologic drug is treated with either ice packs or heating for two to three minutes prior to the injection.

The investigators' aim is to include a total of 110 patients into this study, who have been started by their physician on one of these biologic drugs, such as etanercept, adalimumab, ustekinumab, or receiving secukinumab as part of a research study. Patients will be recruited at the Dermatology department. Patients who are receiving a biologic drug, which is injected subcutaneously (into their skin) are eligible to participate in this study.

Each patient will receive his/her injection at our study site, by a study doctor/investigator. The same designee should inject the subject all three times. Each patient will receive a total of three of their biologic drug injections at the study site, so he/she can receive the injection once following pre-treatment with ice, once following pre-treatment with heating, and once without any pre-treatment.

Patients will then be asked to mark the intensity of the pain associated with the injection on a scale, consisting of a horizontal line, by placing a single mark on the scale. The order of pre-treatment with ice or heat, or no pre-treatment will be randomized among all subjects (1/3 will receive ice first, 1/3 will receive heat first, 1/3 will receive no treatment first; the same randomization ratio will apply for the second and third injections).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients requiring treatment with a biologic drug
  • Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study-related activity is performed

排除标准

  • Patients receiving concurrent therapeutic injections for other indications
  • Patients who have taken analgesics within 12 hours of their injection
  • A past history of cold-, heat- or pressure-induced urticaria

结局指标

主要结局

Reduction of pain measured on a visual analogue scale

时间窗: At time of injection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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