Massage for Treatment of Pain Advanced Cancer

描述(申请人提供)：背景：疼痛不仅是一种普遍存在的 癌症症状，也是患者报告的症状造成的最大 苦恼。它在晚期和终末期疾病中特别流行。而当 有许多有效的治疗癌症相关疼痛的方法，最值得注意的是 阿片类药物治疗，相当数量的患者经历中度或 尽管管理层做出了最大的努力，但仍存在严重的痛苦。当前国家综合实力 癌症网络癌症疼痛指南建议考虑将按摩作为 一种治疗持续性痛苦的辅助疗法。然而，几乎没有什么高 推拿治疗癌症相关疼痛的质量研究，特别是在晚期 以及濒临死亡的人群。在MSKCC的初步研究中，按摩出现 对疼痛非常有效，至少在短期内是这样。在一系列 超过400名中度至重度疼痛的患者由按摩师在 MSKCC，疼痛评分立即平均降低57% 在治疗之后。 目的：我们计划进行一项推拿止痛的随机第三阶段研究 癌症晚期。在这项建议中，我们计划试行这项研究，以便 是否有必要进行更大规模的试验，如果是，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， 推拿与两个对照组的比较：假抚触或安静 时间到了。60名晚期癌症患者，疼痛在0-10分上超过3分 规模将会累积。患者将完成基线疼痛和情绪评估 然后随机进行三次20分钟的背部治疗 每天按摩，或伪装的治疗触摸或安静的时间。痛苦将会是 每天重新评估六次，并在六天内每天一次进行情绪评分。我们会 如果至少75%的患者提供了可评估的信息，则转移到III期研究 数据，如果应计足够快，那么在适当的样本量之后 计算，对照试验可能在不到两年的时间内完成，以及 如果两组之间的差值的95%可信区间为 包括至少降低20%的治疗后平均疼痛评分 而不是虚假的待遇

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