Background: Acupuncture may be a clinically effective treatment for insomnia. We will perform a multicenter, large-scale, single-blinded, randomized controlled trial to compare the differences in the clinical efficacy between the use of singleacupoints and compatibilityacupoints in the treatment of primary insomnia.
Methods/design: A total of 333 participants will be randomly assigned to 2 acupoint treatment groups or 1 nonacupoint control group in a 1:1:1 ratio by a central stochastic system. The acupuncture groups are: the single acupoint group: Shenmen (HT7); and he compatibility acupoint group: Shenmen (HT7), Baihui (DU20), and Sanyinjiao (SP6). The observation period of this trial will be 10 weeks. All patients will be followed for 1 week before randomization (baseline phase). After randomization, the patients will receive 30 minutes of electro-acupuncture once per day for 5 weeks. In the fourth week after the treatment, follow-up will be performed once. The primary outcome will be the Pittsburgh sleep quality index score at 1 week before randomization and 2 and 8 weeks after randomization. The secondary outcomes will include data from sleep diaries, Athens insomnia scale scores, ShortForm-36 Health Survey scores, electroencephalogram technology results and polysomnogram) results. Patients will be required to complete a sleep diary every day during the treatment period. Patients will also undergo electroencephalogram technology and polysomnogram 1 week before randomization and 5 weeks after randomization. The other secondary outcomes will be measured 1 week before randomization and 5 and 9 weeks after randomization.
Discussion: This trial will be helpful in identifying whether acupuncture at compatibility acupoints is more effective than acupuncture at single acupoints.
Trial registration: Clinical Trials.govNCT02448602, Registered 5May 2015, https://www.clinicaltrials.gov/ct2/show/NCT02448602?term=NCT02448602&rank=1.
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