High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

Study Overview
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Brief Summary
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To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV). To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).

Official Title
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High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability

Conditions
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Chronic Fatigue Syndrome

Intervention / Treatment
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* Other: Acupuncture
* Other: moxibustion
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients meeting criteria of CFS; Aged from 18-65; With no skin lesions for the acupuncture area; Sign on the Informed Consent Form; Exclusion Criteria: Patients who can't accept and are afraid of acupuncture in the acupuncture group. Patients suffering from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of liver, kidney and the hematopoietic system. Persons suffering from a mental disease, Alzheimer's disease or cancer. Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation. Pregnant women and nursing mothers. Persons suffering from thrombocytopenia and abnormalities of blood coagulation function. Persons with alcohol and drug abuse history.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxibustion group<br>drug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa. | Other: moxibustion<br>* Stimulating acupoints by using burned moxa<br>|
| Experimental: Acupuncture group<br>material: stainless steel needle In acupuncture treatment, needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),with manipulations to get Deqi sensation. | Other: Acupuncture<br>* Stimulating acupoints by using stainless steel needles with manual manipulation.<br>|
| Placebo Comparator: Placebo group<br>material: stainless steel needle Needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),but without any manipulations and Deqi sensation. | Other: placebo<br>* Stimulating acupoints by using stainless steel needles without manual manipulation.<br>|
| Experimental: Zusanli（ST36)-acupuncture group<br>material: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture. | Other: Acupuncture<br>* Stimulating acupoints by using stainless steel needles with manual manipulation.<br>|
| Experimental: Guanyuan(RN4)-acupuncture group<br>material: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture. | Other: Acupuncture<br>* Stimulating acupoints by using stainless steel needles with manual manipulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chalder's Fatigue Scale Score(CFSS) | In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale(NRS) | NRC is a 10cm scale to assess the fatigue degree ranging from 0 to 10, the score of 0 stands for 'no fatigue' and 10 for 'serious'. | Two years | 
| 36-item Short-Form Health Survey (SF-36) | SF-36 consists of 36 items categorized as 8 dimensions: social functioning (2 items), role limitation-emotion (3 items), mental health (5 items), physical functioning (10 items), role limitation-physical (4 items), bodily pain (2 items), vitality (4 items), general health (5 items) and 1 question of health change in recent one year. | Two years | 
| Deficiency of Qi Scale Score (DQSS) | In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'. | Two years | 
| Total Power(TP) | Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device. | Two years | 
| Low frequency(LF) | Low frequency band (ms²/Hz, %), detected by portable HRV device. | Two years | 
| High frequency (HF) | High frequency band (ms²/Hz, %), detected by portable HRV device. | Two years | 
| LF/HF | Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results. | Two years | 
| Ultra-low frequency(ULF) | Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device. | Two years | 
| Very low frequency | Very low frequency band (ms²/Hz, %),,detected by portable HRV device. | Two years |