Chengdu university of Traditonal Chinese Medcine
Chengdu, Sichuan, 610075, China
NCT Number: NCT01534130
The investigators will conduct acupuncture for participants with chronic fatigue syndrome(CFS). Firstly the investigators aim to figure out the characteristic of sleep structure of CFS and the changes caused by acupuncture. Secondly the investigators seek to investigate the characteristic of sleep-wake rhythm, slow wave sleep(SWS)-rapid eye movement(REM)sleep rhythm, and REM sleep rhythm of CFS and the readjusting of acupuncture for it. Thirdly the investigators want to know the efficacy of acupuncture for relieving the fatigue, reducing accompanying symptoms and for improving the life quality of CFS.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610075, China
This trial is a randomized, placebo controlled clinical trial. 72 participants with CFS are randomly allocated to two different groups. Treatment group is acupuncture, while the control group is sham acupuncture. The ratio of treatment group and control group is 2:1. Both acupuncture and sham acupuncture group will receive 12 sessions of verum/sham acupuncture in 4 weeks.
The result of this trial (available in 2011) will supply evidence on the efficacy of acupuncture for sleep disorder of CFS.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive five sessions of verum acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.
Other names: Streitberger needles(Special No.16)
Participants will receive five sessions of sham acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.
Other names: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).
Time frame: Change from baseline in sleep perception at 4 weeks
The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG.
Time frame: Change from baseline in PSQI at 4 weeks
Time frame: Change from baseline in FSS at 4 weeks
Time frame: Change from baseline in SPHR at 4 weeks
Time frame: Change from baseline in SF-36 at 4 weeks
Time frame: Change from baseline in sleep-wake rhythm at 4 weeks
Time frame: Change from baseline in DSWS-REM sleep rhythm at 4 weeks
Time frame: Change from baseline in REM sleep rhythm at 4 weeks
Time frame: Change from baseline in sleep latency at 4 weeks
Time frame: Change from baseline in total sleep time at 4 weeks
Time frame: Change from baseline in sleep efficiency at 4 weeks
Time frame: Change from baseline in percentage of every sleep stage at 4 weeks
Chengdu University of Traditional Chinese Medicine
Other
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