研究疾病:
|
骨转移癌痛
|
研究疾病代码:
|
|
Target disease:
|
Bone metastatic cancer pain
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
探索性研究/预试验
Pilot clinical trial
|
研究目的:
|
这项研究目的是对医联体电针耳穴结合三阶梯止痛药物对肾虚血瘀骨转移癌针灸镇痛干预研究,制定可推广的、实用性强的医者干预和癌痛患者自我管理的针灸镇痛方案。这项研究已通过广州市黄埔区黄埔街社区卫生服务中心伦理委员会的审查。
|
Objectives of Study:
|
The purpose of this study is to study the acupuncture analgesic intervention of the medical association electro-acupuncture ear acupuncture combined with three-step analgesic drugs for kidney deficiency blood and stasis metastatic carcinoma, and to formulate a generalizable and practical doctor intervention and self-management acupuncture analgesia program for cancer patients. The study has been reviewed by the Ethics Committee of the Huangpu Street Community Health Service Center in Huangpu District, Guangzhou.
|
药物成份或治疗方案详述:
|
(1)治疗组措施:电针耳穴结合止痛药物
针刺治疗:主穴:大椎,华佗夹脊,命门,肾俞,四花穴
操作方法:上述穴位常规消毒后进针,徐入徐出的提插手法,得气后留针30分钟,夹电,连续波。
耳穴:取肝,脾,皮质,内分泌,神门
止痛药物疗法
上述治疗同时进行,每周2次治疗,连续4周。
(2)对照组措施:药物止痛疗法
按照原医嘱口服或者外用止痛药物。
|
Description for medicine or protocol of treatment in detail:
|
(1) Treatment group measures: electric needle ear acupuncture combined with analgesic drugs
Acupuncture treatment: main acupuncture: large vertebrae, Hua Tuo ridge, life gate, kidney Yu, four flower acupuncture
Operation method: the needle is entered after the routine disinfection of the above acupuncture points, the needle is lifted in and out, the needle is left for 30 minutes after getting the gas, and the electricity is clamped and the continuous wave is continuous.
Ear acupuncture: take the liver, spleen, cortex, endocrine, shenmen
Analgesic drug therapy
The above treatment is carried out simultaneously, 2 times a week for 4 weeks.
(2) Control group measures: drug analgesic therapy
Oral or topical pain medication as prescribed by the original doctor.
|
纳入标准:
|
经组织学或细胞学确诊为恶性肿瘤且经X线片、CT、MRI、ECT 或PET-CT 检査结合临床表现证实为骨转移癌。证型符合肾虚血瘀型患者。①年龄30 ~75岁,预计生存期大于1个月;②根据2015年美国成人癌痛临床实践指南,癌痛病因,直接由肿瘤引起,包括原发肿瘤和/或转移性肿瘤引起的疼痛;由肿瘤治疗引起的疼痛;与肿瘤相关的疼痛;③有与肿瘤骨转移相关的骨骼疼痛且癌痛NRS (疼痛数字评定法)>4分;④卡氏功能状态评分(KamofskyPerformance Status,KPS)≥60分;⑤语言表达能力正常,对自身一般状况和疼痛有判断能力,依从性良好,与合作研究者且能表达评价疼痛。
|
Inclusion criteria
|
Histological or cytologically confirmed malignancy and clinical manifestations by X-ray, CT, MRI, ECT, or PET-CT tests combined with bone metastatic carcinoma. The syndrome is consistent with patients with renal deficiency and blood stasis. (1) Age 30 to 75 years old, estimated survival period greater than 1 month; (2) According to the 2015 U.S. Clinical Practice Guidelines for Cancer Pain in Adults, the cause of cancer pain is directly caused by tumors, including pain caused by primary tumors and/or metastatic tumors; pain caused by tumor treatment; pain associated with tumors; (3) bone pain associated with bone metastases of tumors and cancer pain NRS (Pain Numerical Assessment Method) > 4 points; (4) Kamofsky Performance Status (KPS) ≥ 60 points; (5) Normal language expression ability, judgment ability of their general condition and pain, good compliance, and can express and evaluate pain with cooperative researchers.
|
排除标准:
|
①治疗前疼痛剧烈,NRS≥9分,吗啡用量较大仍不能缓解疼痛者;②一个月内对肿瘤部位或疼痛部位使用了放疗、化疗或神经阻断治疗;③非癌性疼痛,如手术切口痛等;④合并严重心、肝、肾、造血系统功能不全等;⑤晕针或对针灸治疗存在恐惧或抗拒者;⑥有智力障碍或伴有听力、精神、认知、意识障碍者;⑦参与其他研究项目者。
|
Exclusion criteria:
|
(1) Severe pain before treatment, NRS ≥ 9 points, morphine dosage is large but still can not relieve pain; (2) within one month of the tumor site or pain site used radiotherapy, chemotherapy or nerve blockade therapy; (3) non-cancer pain, such as surgical incision pain, etc.; (4) combined severe heart, liver, kidney, hematopoietic system insufficiency, etc.; (5) halo needles or fear or resistance to acupuncture treatment; (6) intellectual disabilities or accompanied by hearing, mental, cognitive, and cognitive impairment; (7) participants in other research projects.
|
研究实施时间:
Study execute time:
|
从From
2020-05-01
至To
2021-12-21
|
征募观察对象时间:
Recruiting time:
|
从From
2020-05-01
至To
2021-12-21
|