Acupuncture for the Sleep Disorder of Chronic Fatigue Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Device: Acupuncture; Device: Sham acupuncture

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Si Chuan Province
    • Chengdu, Si Chuan Province, China, 610075
      • Chengdu university of Traditonal Chinese Medcine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture	Device: Acupuncture; 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)
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 Names: Streitberger Placeboneedles(Gauge 8 x 1.2"/0.30 x 30 mm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Collaborators: West China Hospital
• Investigators: Study Director: Xi Wu, A.P., School of Acupuncture& Tuina，Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: December 14, 2011
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Acupuncture; Chronic Fatigue Syndrome; Sleep Disorder, Adjustment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Sleep Wake Disorders; Parasomnias; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 30801488