Manual Lymphatic Drainage Integrated With Kinesio Tape and Traditional Rehabilitation Techniques in Patients Operated for Knee Arthroplasty in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Pain severity
研究概览
简要总结
Aim of the study: To evaluate the efficacy of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint ROM in patients undergoing surgery of total knee arthroplasty in osteoarthritis.
Inclusion criteria: Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery, Patients of both sexes aged between 65 and 85, Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3 cm.
Exclusion criteria: Patients operated for re-implantation or revision, presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies, absence of DVT of the lower limb.
Study design: Prospective, open, randomized, lasting 12 months GROUP 1 (33 pts) KINESIOTAPING + STANDARD REHABILITATION GROUP 2 (33 pts) LYMPHODRAINAGE+ STANDARD REHABILITATION GROUP 3 (33 pts) KINESIOTAPING + LYMPHODRAINAGE + STANDARD REHABILITATION Outcome measures: Pain: evaluation with NRS scale 0-10, Edema: cirtometric evaluation (in 4 standard points), ROM: goniometric measurement of the knee joint excursion. All measures at the beginning and end of treatment (6 days).
详细描述
Background In the days following knee arthroplasty, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, sometimes it can take longer, and sometimes result in a condition of chronic inflammation, albeit modest, that lasts for years. Lymphodrainage and Kinesiotaping have been indicated as effective treatments to reduce edema and alleviate pain. However it is not clear which of these techniques is more effective and if their effectiveness increases when combined.
Objective of the study The objective of the study is to evaluate the effectiveness of lymphatic drainage treatment associated with the application of kinesiotaping in the reduction of lymphedema, pain and in the recovery of knee joint excursion (ROM) in patients undergoing total arthroplasty knee in osteoarthritis. The hypothesis is that the associated treatment of kinesiotaping and lymphatic drainage produces better results than the individual treatments.
Methods
Patients will be divided in 3 groups according to the type of treatment:
GROUP 1 Lymphatic drainage + standard rehabilitation GROUP 2 Kinesiotaping + standard rehabilitation GROUP 3 Lymphatic drainage + Kinesiotaping + standard rehabilitation For each patient the duration of the study will be 6 days, the total duration of the study will be 12 months.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operated patients of total primary knee arthroplasty in osteoarthritis not later than 5 days after surgery
- •Patients of both sexes aged between 65 and 85;
- •Presence of lymphedema and volumetric difference with the contralateral limb of the cirtometry equal or greater than 3cm.
排除标准
- •Patients operated for re-implantation or revision
- •Presence of inflammatory, neurological, important cardiological diseases and active tumor pathologies.
- •Absence of DVT of the lower limb.
结局指标
主要结局
Pain severity
时间窗: Change between baseline and the end of treatment (6 days)
NRS Pain: the Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. Pain Level rating: 0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-10 Severe Pain
次要结局
- Edema(Change between baseline and the end of treatment (6 days))
- KNEE ROM(Change between baseline and the end of treatment (6 days))
研究者
Laura Tornatore
Physical Therapist
Istituto Ortopedico Rizzoli