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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental |
| |
| sham acupuncture | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The sleep perception | The percentage of the ratio between the total sleep time perceived by the patient and the total sleep time obtained by PSG. | Change from baseline in sleep perception at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Pittsburgh Sleep Quality Index(PSQI) | Change from baseline in PSQI at 4 weeks | |
| The Fatigue Severity Scale(FSS) | Change from baseline in FSS at 4 weeks | |
| The Somatic and Psychological Health Report(SPHR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xi Wu, A.P. | School of Acupuncture& Tuina,Chengdu University of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu university of Traditonal Chinese Medcine | Chengdu | Sichuan | 610075 | China |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D020920 | Dyssomnias |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham acupuncture | Device | 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. |
|
|
| Change from baseline in SPHR at 4 weeks |
| The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36) | Change from baseline in SF-36 at 4 weeks |
| Sleep-wake rhythm | Change from baseline in sleep-wake rhythm at 4 weeks |
| DSWS-REM sleep rhythm | Change from baseline in DSWS-REM sleep rhythm at 4 weeks |
| REM sleep rhythm | Change from baseline in REM sleep rhythm at 4 weeks |
| Sleep latency | Change from baseline in sleep latency at 4 weeks |
| Total sleep time | Change from baseline in total sleep time at 4 weeks |
| Sleep efficiency | Change from baseline in sleep efficiency at 4 weeks |
| Percentage of every sleep stage | Change from baseline in percentage of every sleep stage at 4 weeks |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |