Massage for Treatment of Pain Advanced Cancer

描述（由申请人提供）：背景：疼痛不仅是一种普遍的 癌症症状，而且也是患者报告的引起最大的症状 痛苦它在晚期和终末期疾病中特别普遍。而 有许多有效的治疗癌症相关疼痛的方法， 阿片类药物，大量患者经历中度或 尽管有最好的管理措施，但仍然存在严重的疼痛。当前全国综合 癌症网络癌症疼痛指南建议考虑按摩， 对持续性痛苦的辅助治疗然而，高 按摩治疗癌症相关疼痛的质量研究，特别是在晚期阶段 和临终人口。在MSKCC的初步研究中， 至少在短期内对疼痛非常有效。一系列 超过400名患有中度至重度疼痛的患者接受了按摩师的治疗， MSKCC，疼痛评分立即平均降低了57% 治疗后。 建议：我们计划进行一项按摩止痛的随机III期研究 在晚期癌症中。在本提案中，我们计划试行此类研究，以便 是否需要进行更大规模的试验，如果需要，提供数据以帮助研究 设计 方法：这项随机研究将测试按摩减轻疼痛的能力， 比较按摩与两个对照组：假治疗触摸或安静 时间60例晚期癌症患者，疼痛大于3，0 - 10 规模将增加。患者将完成基线疼痛和情绪评估 然后将被随机分为三个20分钟的背部治疗， 按摩每天，或假治疗触摸或安静的时间。痛苦将 每天重新评估六次，情绪评分每天一次，持续六天。我们将 如果至少75%的患者提供可评价的结果，则进入III期研究 数据，如果累积速度足够快， 计算，对照试验可以在不到两年的时间内完成， 如果组间差异的95%置信区间 包括按摩治疗后平均疼痛评分至少降低20% 比假治疗

DESCRIPTION (provided by applicant): BACKGROUND: Pain is not only a pervasive cancer symptom, but also the symptom reported by patients to cause greatest distress. It is particularly prevalent in advanced and end-stage disease. While there are many effective treatments for cancer-related pain, most notably opiate medication, a significant number of patients experience moderate or severe pain despite best management efforts. Current National Comprehensive Cancer Network guidelines for cancer pain recommend consideration of massage as an ancillary treatment for persisting distress. However, there are few high quality studies of massage for cancer-related pain, particularly in late stage and end-of-life populations. In preliminary studies at MSKCC, massage appears to be highly effective for pain, in the short term at least. In a series of over 400 patients with moderate to severe pain seen by massage practitioners at MSKCC, pain scores were reduced by an average of 57 percent immediately following treatment. OBJECTIVES: We plan to conduct a randomized Phase III study of massage for pain in advanced cancer. In this proposal, we plan to pilot such a study in order to whether a larger trial is warranted, and if so, to provide data to aid study design. METHODS: This randomized-study will test the ability of massage to reduce pain, comparing massage with two control groups: sham therapeutic touch or quiet time. Sixty patients with advanced cancer and pain greater than 3 on a 0-10 scale will be accrued. Patients will complete baseline pain and mood evaluation scales and will then be randomized to three 20-minute treatments of back massage daily, or to sham therapeutic touch or quiet time. Pain will be reassessed six times a day and mood scores once a day for six days. We will move to a Phase III study if at least 75 percent of patients provide evaluable data, if accrual is sufficiently rapid so that, after suitable sample size calculations, a controlled trial could be completed in less than two years, and if the 95 percent confidence interval for the difference between group means includes at least a 20 percent lower mean post-treatment pain score on massage than sham treatment