High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust210 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

210

Conditions

Chronic Fatigue Syndrome

Interventions

AcupunctureOTHER

Stimulating acupoints by using stainless steel needles with manual manipulation.

moxibustionOTHER

Stimulating acupoints by using burned moxa

placeboOTHER

Stimulating acupoints by using stainless steel needles without manual manipulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hubei university of TCM

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Chalder's Fatigue Scale Score(CFSS)

In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.

Time frame: Two years

Secondary Outcomes

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'.

Time frame: 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.

Time frame: 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'.

Time frame: Two years

Total Power(TP)

Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.

Time frame: Two years

Low frequency(LF)

Low frequency band (ms²/Hz, %), detected by portable HRV device.

Time frame: Two years

High frequency (HF)

High frequency band (ms²/Hz, %), detected by portable HRV device.

Time frame: Two years

Central Contacts

Liang feng xia, Doctor

CONTACT

+86 18971371818 315938821@qq.com

Data from ClinicalTrials.gov

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