研究疾病:
|
绝经后骨质疏松症
|
研究疾病代码:
|
|
Target disease:
|
postmenopausal osteoporosis
|
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:
|
观察明确针刺治疗绝经后骨质疏松症患者的可行性及初步疗效
|
Objectives of Study:
|
Observing and clarifying the feasibility and preliminary efficacy of acupuncture in the treatment of postmenopausal patients with osteoporosis
|
药物成份或治疗方案详述:
|
基础治疗:
试验组与对照组患者均服用骨健康基本补充剂。选用钙尔奇 D。
试验组治疗:
采用针刺治疗。
针刺方法:取肾俞、足三里、太溪、绝骨、大杼、阳陵泉,均取双侧。嘱患
者取俯卧位,穴位局部用 75%乙醇常规消毒,取 0.30 mm×25~50 mm 一次性无菌针灸针(汉医牌,长春爱康医疗器械有限公司生产)进行针刺,针刺深度视患者胖瘦及所刺穴位深浅而定。肾俞、太溪直刺 0.5~1 寸,当产生酸、胀、麻等得气感后,肾俞、太溪施捻转补法,绝骨行平补平泻。以上穴位操作后,均留针30 分钟。每周 2 次。
对照组治疗:
采用假针刺(安慰针刺)治疗。
假针刺方法:非穴位浅刺。
每周 2 次。
|
Description for medicine or protocol of treatment in detail:
|
Basic Treatment
Patients in the test and control groups are given a basic bone health supplement. Calcium D is chosen.
Test group treatment:
Treatment with acupuncture.
Acupuncture method: Taking BL23ST36KI3GB39BL11GB34, all on both sides.The patient is instructed to the patient to be in the prone position and the acupuncture point to be disinfected locally with 75% ethanol routinely. 0.30 mm×25-50 mm disposable sterile acupuncture needles (Han Medical brand, produced by Changchun Aikang Medical Equipment Co., Ltd.) are taken for acupuncture.The depth of needling depends on the fatness of the patient and the depth of the acupuncture point.BL23 and KI3: 0.5 to 1 inch.When a feeling of soreness, swelling, numbness, etc. is produced, apply the twisting and tonifying method to BL23 and KI3. GB39 for average tonic and diarrhea. After the above points are operated, the needles are left in place for 30 minutes. 2 times per week.
Control group treatment:
Treatment with sham acupuncture.
Sham acupuncture method: shallow pricking at non-acupuncture points.
2 times per week.
|
纳入标准:
|
(1)符合绝经后骨质疏松症诊断标准;
(2)45 岁(含)至 70 岁(不含)的绝经后骨质疏松症患者;
(3)基线 VAS≥4 分,且 VAS<7 分;
(4)自愿参加本次临床研究,签署知情同意书。
|
Inclusion criteria
|
(1)Meets diagnostic criteria for postmenopausal osteoporosis
(2)Patients with postmenopausal osteoporosis between the ages of 45 (inclusive) and 70 (exclusive)
(3)Baseline VAS ≥ 4 points and VAS < 7 points
(4)Voluntary participation in this clinical study, signed informed consent form
|
排除标准:
|
(1)继发性骨质疏松症或近 1 年内有骨质疏松性骨折史;
(2)合并有类风湿性关节炎、骨性关节炎、糖尿病、胃肠道疾病等;
(3)严重心、肝、肾等脏器功能不全、血液系统及自身免疫疾病、急慢性
感染、恶性肿瘤或或严重精神疾病者;
(4)具有甲状腺、垂体、下丘脑及其他内分泌疾病史;
(5)近 1 年内使用过唑来膦酸盐,近半年内使用过地舒单抗,口服双膦酸
盐、抗骨质疏松中药制剂如护骨胶囊,金天格胶囊等停用不足 3 个月;
(6)常年服用激素如糖皮质激素、性激素,活性维生素 D 、氟化物、抗癫
痫药物等;
(7)无法配合完成本研究者。
|
Exclusion criteria:
|
(1)Secondary osteoporosis or history of osteoporotic fracture within the last 1 year
(2)Combined with rheumatoid arthritis, osteoarthritis, diabetes, gastrointestinal diseases, etc.
(3)Severe cardiac, hepatic, renal and other organ insufficiencies, hematologic and autoimmune diseases, acute and chronic infections, malignant tumors, or serious mental illnesses
(4)History of thyroid, pituitary, hypothalamus and other endocrine disorders
(5)Use of zoledronate within the last 1 year, use of disulfiramab within the last 6 months, oral bisphosphonates Salt, anti-osteoporosis herbal preparations such as bone care capsule, Jin Tian Ge capsule, etc. discontinued for less than 3 months
(6)Year-round use of hormones such as glucocorticoids, sex hormones, active vitamin D, fluoride, anti-seizure epileptic drugs, etc.
(7)Those unable to cooperate in completing this study
|
研究实施时间:
Study execute time:
|
从From
2022-12-01
至To
2024-04-01
|
征募观察对象时间:
Recruiting time:
|
从From
2022-12-01
至To
2024-04-01
|