High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02924831
• Other study ID #: XTCX2016-QXZ
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 27, 2016
• Last updated: October 3, 2016
• Start date: November 2016
• Est. completion date: July 2018

Study information

• Verified date: July 2016
• Source: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
• Contact: Liang feng xia, Doctor
• Phone: +86 18971371818
• Email: 315938821[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei Province
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Other:
• Acupuncture
Stimulating acupoints by using stainless steel needles with manual manipulation.
• moxibustion
Stimulating acupoints by using burned moxa
• placebo
Stimulating acupoints by using stainless steel needles without manual manipulation.

Locations

Country	Name	City	State
China	Hubei university of TCM	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chalder's Fatigue Scale Score(CFSS)	In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.	Two years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Total Power(TP)	Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.	Two years	No
Secondary	Low frequency(LF)	Low frequency band (ms²/Hz, %), detected by portable HRV device.	Two years	No
Secondary	High frequency (HF)	High frequency band (ms²/Hz, %), detected by portable HRV device.	Two years	No
Secondary	LF/HF	Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.	Two years	No
Secondary	Ultra-low frequency(ULF)	Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.	Two years	No
Secondary	Very low frequency	Very low frequency band (ms²/Hz, %),,detected by portable HRV device.	Two years	No