Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Chronic Fatigue Syndrome

Treatments: Device: Acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01534130

30801488

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants who meet the diagnosis criteria of CFS;
2. Clinically evaluated, exclude any disease that can explain the chronic fatigue;
3. The onset age of CFS is between 18 and 50 years old;
4. Have not taken any hypnotic, melatonin, or antidepressants within 45 days;
5. Willing to finish the whole observation period;
6. With written consent form signed by themselves.

Exclusion criteria

1. Chronic fatigue caused by diseases such as internal diseases(for example, pulmonary emphysema, rheumatoid arthritis, etc.), mental illness(for example, any type of dementia paranoids, depression, etc.), some diseases that just onset or evaluated (for example, sleep deprivation, untreated diabetes, etc.), some diseases that need recovery gradually(for example, restless legs syndrome, lactation, etc.), morbid obesity;
2. Participants in other clinical research;
3. Pregnant women, lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

acupuncture

Experimental group

Treatment:

Device: Acupuncture

sham acupuncture

Sham Comparator group

Treatment:

Device: Sham acupuncture