A Randomized Study to Assess the Efficacy of Early Physical Therapy Intervention on Upper Quarter Strength and Mobility, and Reported Upper Extremity Disability and Quality of Life Measures Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disability of the Arm Shoulder and Hand
研究概览
简要总结
This study will determine whether patients who receive regular physical therapy immediately following a modified neck dissection surgery will report decreased shoulder disability, decreased pain, improved or maintained shoulder range of motion and strength, and improved quality of life than those who receive only home instruction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-85, able to give informed consent
- •Subject has provided written informed consent
- •Received Modified Unilateral Neck Dissection with sparing of the SAN
- •Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality
- •Not currently receiving acupuncture as a pain relieving modality
- •Able to participate with treatment group protocol including physical therapy appointment every other week
排除标准
- •History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty.
- •History of CVA with hemi paresis
- •Bilateral neck dissection
- •Known severed SAN
研究组 & 干预措施
Home Program
Participants perform home program only.
Physical Therapy Intervention
Physical therapy intervention provided for first 12 weeks following surgery.
干预措施: Physical therapy intervention (Other)
结局指标
主要结局
Disability of the Arm Shoulder and Hand
时间窗: 12, 24, 36 weeks
A standardized outcome tool which will be used to measure change in the level of disability related to involvement of the upper extremity at 12, 24, and 36 weeks compared to baseline.
次要结局
- SF-36(12, 24, 36 weeks)
研究者
Melissa M. Eden
Physical Therapist, Orthopedic Clinical Specialist, Primary Investigator
Mayo Clinic