Therapeutic Chinese Foot Massage for Peripheral Neuropathy Symptoms Among People With Human Immunodeficiency Virus: A a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Lower extremity pain
研究概览
简要总结
Peripheral neuropathy (PN) is a common neurological complication in people with human immunodeficiency virus (PHIV) with no Food and Drug Administration-approved treatment. Medications commonly used to treat HIV-related PN are not effective and have many side effects. HIV-related PN symptoms may be alleviated or treated with therapeutic Chinese foot massage (TCFM), a non-invasive, relatively safe, non-pharmacological intervention.
详细描述
This is a prospective, two-arm, double-blinded, randomized controlled trial. Aim: This trial aims to assess the effectiveness of TCFM on HIV-related PN in people with HIV (PHIV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants, the outcome assessors, and the statistician will be unaware of the group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have confirmed HIV diagnosis
- •self-report PN-related symptoms in their lower extremity, such as sharp, jabbing, throbbing, or burning pain, numbness, decreased sensation to pinprick, prickling or tingling feeling, lack of coordination and falling muscle weakness, and extreme sensitivity to touch
- •are not taking any medications, including pain medicine, to alleviate PN
- •age 18 years and older
- •can communicate with researchers in English or Mandarin Chinese
- •are not pregnant or lactating
- •are not concurrently enrolled in other clinical trials.
排除标准
- •People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months
结局指标
主要结局
Lower extremity pain
时间窗: at 6 months
The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.
Lower extremity functioning
时间窗: at 6 months
The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning.
次要结局
未报告次要终点
研究者
Song Ge
Assistant Professor
University of Houston Downtown