Clinical Trial: Efficacy Study of Acupuncture in the Prevention of Migraine Without Aura

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Clinical Efficacy of Acupuncture in the Prevention of Migraine Without Aura: a Randomized Sham-controlled Trial

Brief Summary: The purpose of this study is to evaluate the efficacy of verum acupuncture (VA) for the prevention of migraine without aura compared to non-penetrating sham acupuncture (SA) and usual care alone (UC). This study also aims to determine whether the intensity of deqi sensations and psychosocial factors (including patient expectations, patient personality traits, patient-doctor relationship, traditional Chinese medicine constitution, depression, anxiety, sleep quality, etc.) are associated with clinical outcomes.

Detailed Summary: The trail consists of three periods: baseline period before treatment and randomization (week-4 to week 0), treatment period (week 1 to week 8), and follow-up period (week 9 to week 20).A total of 150 participants will be randomly assigned to verum acupuncture(VA)group, sham acupuncture(SA)group, and usual care(UC) group in a ratio of 2:2:1. The primary outcome measures are the change of migraine days and migraine attacks in a cycle of 4 weeks compared to baseline. The secondary outcome measures are the proportion of responders, headache intensity, intake of acute medication, and the change of life quality and sleep quality. Deqi sensations will be measured by the Chinese version of the Massachusetts General Hospital Acupuncture Sensation Scale. Psychological outcome measures are Beck Depression Rating Scale, Beck Anxiety Inventory, NEO Five-Factor Inventory, Doctor-Patient Relationship Scale, and Difficult Doctor-Patients Relationship Scale. Participants will be asked to complete headache diaries from the baseline to follow-up period. The central randomization and data collection will be conducted by an electronic data management system.
Sponsor: Wei Wang

Current Primary Outcome:

  • Change in the number of migraine days [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in the frequency of migraine attacks [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]


Original Primary Outcome:

  • Change in the number of migraine days [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in the frequency of migraine attacks [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]


Current Secondary Outcome:

  • The proportion of responders [ Time Frame: At weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in visual analogue scale [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in Migraine Disability Assessment questionnaire(MIDAS). [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
  • Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1. [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in 36-Item Short-Form Health Survey(SF-36). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in Pittsburgh Sleep Quality Index(PSQI). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in the dose of intake of acute medication. [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]


Original Secondary Outcome:

  • The proportion of responders [ Time Frame: At weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in visual analogue scale [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in Migraine Disability Assessment questionnaire(MIDAS). [ Time Frame: At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. ]
  • Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1. [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in 36-Item Short-Form Health Survey(SF-36). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in Pittsburgh Sleep Quality Index(PSQI). [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]
  • Change in the dose of intake of acute medication. [ Time Frame: At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after radomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. ]


Information By: Huazhong University of Science and Technology

Dates:
Date Received: April 10, 2016
Date Started: May 2016
Date Completion: December 2018
Last Updated: May 28, 2016
Last Verified: May 2016