ChiCTR-IOR-16008001Active, not recruitingNot Applicable
平衡针灸针刺偏头痛患者头痛穴的短期疗效及脑 fMRI 研究
广东省科学技术厅1 site in 1 country40 target enrollmentStarted: July 1, 2015Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 脑功能磁共振
Study Overview
Brief Summary
（1）通过采用平衡针灸针刺治疗偏头痛患者，评价平衡针灸针刺的短期疗效。研究平衡针作为中国传统医学治疗方法，在偏头痛治疗中，乃至急诊痛症治疗中的作用。 （2）从功能磁共振的角度探讨平衡针灸治疗的作用机理。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Ages
- 18 to 45 (—)
- Sex
- All
Inclusion Criteria
- •1.18 岁≤年龄≤65 岁；
- •2.男女不限，右利手；
- •3.符合西医无先兆偏头痛诊断标准，且初次发病的年龄<50 岁；
- •4.就诊前 3 个月头痛发作≥6 次，且 2 次≤每月发作次数≤6 次；
- •5.中、重度疼痛，影响工作学习，3.6 分＜NRS 评分≤10 分；
- •6.近 3 月来未服用精神类药物及血管活性药物，无长期服用镇痛药物习惯；
- •7.体内无金属植入物、无幽闭恐惧症等磁共振及 fMRI 检测禁忌症；
- •8.受试者知情，自愿签署知情同意书。
Exclusion Criteria
- •1.其它疾病引起的头痛；
- •2.特殊类型的偏头痛，如眼肌麻痹型偏头痛，偏瘫型偏头痛等类型；
- •4.不能理解并进行数字疼痛量表测定；
- •5.月经期女性和妊娠或哺乳期妇女者；
- •6.合并循环、呼吸、消化等系统严重原发性疾病，严重精神病患者或易出血及感染者；
- •7.存在肿瘤、痛风、风湿性关节炎等其他疾病所致的慢性疼痛；
- •8.既往脑出血、脑梗塞等颅内器质性病变或 MR 扫描过程中发现严重的头颅解剖结构不对称或者颅内明确病变（其中脑白质疏松者 Aharon-Peretz 标准 3 级及 3 级以上）；
- •9.近一月来服用预防偏头痛的药物；
- •10.患者 3 个月内参加了其他临床试验。
Arms & Interventions
1
平衡针刺治疗
2
穴位
Outcomes
Primary Outcomes
脑功能磁共振
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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