High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

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

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 Overview

• Status: Unknown
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Other: moxibustion; Other: Acupuncture; Other: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liang feng xia, Doctor; Phone Number: +86 18971371818; Email: 315938821@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Hubei university of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: XTCX2016-QXZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided