Effectiveness of the Osteopathic Pedal Pump in Reducing Lower Limb Volume in Older Adults with Chronic Leg Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Osteopathic Pedal Pump
Participant lays supine on the table and the operator stands at foot of table. Operator places hands on the feet, contacting the balls of the feet, and carefully plantar flexing to a slight degree. Operator dorsiflexes the feet to cause the whole body to move cephalad. The body is allowed to rebound back caudad towards foot of the table. The operator times the next dosiflexion motion to occur towards the end of the caudad motion wave. Technique time is 5 minutes.
干预措施: Osteopathic Pedal Pump (Other)
Light Touch Treatment
Participant lays supine on the table and the operator stands at foot of table. Operator places hands on the feet and touches participant body on the balls of the feet, but operator does not palpate feet or lower limbs.
干预措施: Light Touch Treatment (Other)
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