Acupuncture for Pain and Dysfunction Following Neck Dissection: A Randomized, Controlled, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Pain, function and activities of daily living as measured by the Constant-Murley instrument
研究概览
简要总结
RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is not yet known whether acupuncture is more effective than standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.
PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether acupuncture reduces pain and dysfunction in patients with head and neck cancer who have undergone neck dissection.
Secondary
- Determine whether acupuncture relieves dry mouth in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Must have undergone neck dissection for cancer ≥ 3 months ago (in order to qualify pain as chronic sequella)
- •Subjective complaint of pain and/or dysfunction in the neck and/or shoulders that, in the opinion of the investigator, is due to neck dissection
- •Constant-Murley score ≤ 70 (i.e., moderate or severe pain and dysfunction)
- •No moderate or severe neck or shoulder pain that, in the opinion of the investigator, is not due to cancer surgery
- •PATIENT CHARACTERISTICS:
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy
- •More than 6 weeks since prior acupuncture
- •Concurrent analgesics allowed
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
干预措施: acupuncture therapy (Procedure)
Arm II
Patients undergo standard of care for 4 weeks.
干预措施: standard follow-up care (Procedure)
结局指标
主要结局
Pain, function and activities of daily living as measured by the Constant-Murley instrument
次要结局
- Xerostomia as measured by the Xerostomia Inventory questionnaire