High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

Phase 2

• Conditions: Chronic Fatigue Syndrome
• Interventions: Other: moxibustion; Other: Acupuncture; Other: placebo

• Registration Number: NCT02924831
• Lead Sponsor: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-05
• Last Update Posted: 2016-10-05
• Study Start: 2016-11
• Primary Completion: 2018-05
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxibustion group	moxibustion	drug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa.
Zusanli（ST36)-acupuncture group	Acupuncture	material: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture.
Placebo group	placebo	material: stainless steel needle Needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),but without any manipulations and Deqi sensation.
Acupuncture group	Acupuncture	material: stainless steel needle In acupuncture treatment, needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),with manipulations to get Deqi sensation.
Guanyuan(RN4)-acupuncture group	Acupuncture	material: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture.

Primary Outcome Measures

Name	Time	Method
Chalder's Fatigue Scale Score(CFSS)	Two years	In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.

Secondary Outcome Measures

Name	Time	Method
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'.
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.
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'.
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.
Low frequency(LF)	Two years	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.
Very low frequency	Two years	Very low frequency band (ms²/Hz, %),,detected by portable HRV device.
Total Power(TP)	Two years	Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.

Trial Locations

Locations (1)

Hubei university of TCM; 🇨🇳 Wuhan, Hubei, China