跳至主要内容
临床试验/NCT06235463
NCT06235463招募中不适用

Effectiveness of the Osteopathic Pedal Pump in Reducing Lower Limb Volume in Older Adults with Chronic Leg Lymphedema

Rowan University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年4月9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
72
试验地点
2
主要终点
Change in limb volume

研究概览

简要总结

Chronic lymphedema in the lower extremities is a common problem found in older adults that can result in cellulitis, poor wound healing, venous stasis ulcers, and other comorbidities. Compressive therapies are the present gold standard for the manual treatment of lymphedema in the lower extremities. However, the benefits of these compressive therapies are modest, and they are not well tolerated by older adults. An alternative manual treatment is the osteopathic pedal pump, an osteopathic manipulative treatment, that uses a rhythmical pumping motion instead of compressive force to move interstitial fluid from the lower extremities back to the circulatory system. However, the evidence that the osteopathic pedal pump can reduce volume in the lower extremities remains anecdotal. The aim of this study is to determine if the osteopathic pedal pump can reduce volume in the lower extremities among older adults with chronic lymphedema. Leg volume will be measured using water displacement. Older adults with chronic lymphedema of the lower extremities will be randomly assigned to one of two groups: a treatment group that will receive one session of the osteopathic pedal pump and a control group that will receive one session of a light touch treatment.

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 (Investigator)

盲法说明

The investigator who will be responsible for carrying out the measurements of lower limb volume via water displacement will be blinded to the condition each participant is randomized to. Withholding this information from the investigator conducing the measurements will prevent this information from influencing how the measurements are conducted and therefore removing bias that could skew the results in support of the study's hypotheses (i.e., that the pedal pump does reduce lower limb volume in older adults with lower extremity lymphedema).

入排标准

年龄范围
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 55 years old or older
  • Have lower leg lymphedema

排除标准

  • Any type of acute medical issue or exacerbation
  • A chronic medical condition (e.g., asthma, chronic obstructive pulmonary disease, congestive heart failure)
  • An active tissue infection or an open wound in the lower limb
  • An active bone fracture
  • Acute deep venous thrombosis not fully anticoagulated

结局指标

主要结局

Change in limb volume

时间窗: The time frame in which the pre and post-treatment measurements will take place in one session that will take approximately 30-45 minutes.

Difference in lower limb volume, as measured by water displacement, from pre to post-treatment.

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 (2)

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