Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome
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|ClinicalTrials.gov Identifier: NCT01534130|
Recruitment Status : Unknown
Verified August 2012 by Wu Xi, Chengdu University of Traditional Chinese Medicine.
Recruitment status was: Recruiting
First Posted : February 16, 2012
Last Update Posted : August 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome||Device: Acupuncture Device: Sham acupuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
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 Name: Streitberger needles(Special No.16)
|Sham Comparator: sham acupuncture||
Device: Sham acupuncture
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 Name: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).
- The sleep perception [ 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.
- The Pittsburgh Sleep Quality Index(PSQI) [ Time Frame: Change from baseline in PSQI at 4 weeks ]
- The Fatigue Severity Scale(FSS) [ Time Frame: Change from baseline in FSS at 4 weeks ]
- The Somatic and Psychological Health Report(SPHR) [ Time Frame: Change from baseline in SPHR at 4 weeks ]
- The Medical outcomes Study 36-Item Short-Form Health Survey questionnaire(SF-36) [ Time Frame: Change from baseline in SF-36 at 4 weeks ]
- Sleep-wake rhythm [ Time Frame: Change from baseline in sleep-wake rhythm at 4 weeks ]
- DSWS-REM sleep rhythm [ Time Frame: Change from baseline in DSWS-REM sleep rhythm at 4 weeks ]
- REM sleep rhythm [ Time Frame: Change from baseline in REM sleep rhythm at 4 weeks ]
- Sleep latency [ Time Frame: Change from baseline in sleep latency at 4 weeks ]
- Total sleep time [ Time Frame: Change from baseline in total sleep time at 4 weeks ]
- Sleep efficiency [ Time Frame: Change from baseline in sleep efficiency at 4 weeks ]
- Percentage of every sleep stage [ Time Frame: Change from baseline in percentage of every sleep stage at 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534130
|Contact: Xi Wu, A.P.||firstname.lastname@example.org|
|China, Si chuan Province|
|Chengdu university of Traditonal Chinese Medcine||Recruiting|
|Chengdu, Si chuan Province, China, 610075|
|Contact: Xi Wu, A.P. 86-15928830710 email@example.com|
|Principal Investigator: Xiangdong Tang, Professor|
|Principal Investigator: Xiaoqin Chen, Physician|
|Sub-Investigator: Fei Lei, Housestaff|
|Sub-Investigator: Bin Huang, Postgraduate|
|Sub-Investigator: Jun Lin, Postgraduate|
|Sub-Investigator: Rufei Zhang, Postgraduate|
|Study Director:||Xi Wu, A.P.||School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine|