Chronic Fatigue Syndrome
Conditions
Brief summary
1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV). 2. To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).
Interventions
OTHERAcupuncture
Stimulating acupoints by using stainless steel needles with manual manipulation.
OTHERmoxibustion
Stimulating acupoints by using burned moxa
OTHERplacebo
Stimulating acupoints by using stainless steel needles without manual manipulation.
Sponsors
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. The patients meeting criteria of CFS; 2. Aged from 18-65; 3. With no skin lesions for the acupuncture area; 4. Sign on the Informed Consent Form;
Exclusion criteria
1. Patients who can't accept and are afraid of acupuncture in the acupuncture group. 2. 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. 3. Persons suffering from a mental disease, Alzheimer's disease or cancer. 4. Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation. 5. Pregnant women and nursing mothers. 6. Persons suffering from thrombocytopenia and abnormalities of blood coagulation function. 7. Persons with alcohol and drug abuse history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chalder's Fatigue Scale Score(CFSS) | Two years | In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 36-item Short-Form Health Survey (SF-36) | Two years | 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. |
| Deficiency of Qi Scale Score (DQSS) | Two years | In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'. |
| Total Power(TP) | Two years | Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device. |
| Low frequency(LF) | Two years | Low frequency band (ms²/Hz, %), detected by portable HRV device. |
| Numeric Rating Scale(NRS) | Two years | 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'. |
| LF/HF | Two years | Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results. |
| Ultra-low frequency(ULF) | Two years | Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device. |
| Very low frequency | Two years | Very low frequency band (ms²/Hz, %),,detected by portable HRV device. |
| High frequency (HF) | Two years | High frequency band (ms²/Hz, %), detected by portable HRV device. |
Countries
China
Contacts
Primary ContactLiang feng xia, Doctor
Outcome results
None listed