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High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

Primary Purpose

Chronic Fatigue Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Acupuncture
moxibustion
placebo
Sponsored by
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hubei university of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Moxibustion group

Acupuncture group

Placebo group

Zusanli（ST36)-acupuncture group

Guanyuan(RN4)-acupuncture group

Arm Description

drug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa.

material: stainless steel needle In acupuncture treatment, needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),with manipulations to get Deqi sensation.

material: stainless steel needle Needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),but without any manipulations and Deqi sensation.

material: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture.

material: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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'.
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.
Deficiency of Qi Scale Score (DQSS)
In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'.
Total Power(TP)
Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.
Low frequency(LF)
Low frequency band (ms²/Hz, %), detected by portable HRV device.
High frequency (HF)
High frequency band (ms²/Hz, %), detected by portable HRV device.
LF/HF
Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.
Ultra-low frequency(ULF)
Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.
Very low frequency
Very low frequency band (ms²/Hz, %),,detected by portable HRV device.

Full Information

First Posted
September 27, 2016
Last Updated
October 3, 2016
Sponsor
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
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1. Study Identification

Unique Protocol Identification Number
NCT02924831
Brief Title
High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome
Official Title
High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV). To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moxibustion group
Arm Type
Experimental
Arm Description
drug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa.
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
material: stainless steel needle In acupuncture treatment, needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),with manipulations to get Deqi sensation.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
material: stainless steel needle Needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),but without any manipulations and Deqi sensation.
Arm Title
Zusanli（ST36)-acupuncture group
Arm Type
Experimental
Arm Description
material: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture.
Arm Title
Guanyuan(RN4)-acupuncture group
Arm Type
Experimental
Arm Description
material: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Stimulating acupoints by using stainless steel needles with manual manipulation.
Intervention Type
Other
Intervention Name(s)
moxibustion
Intervention Description
Stimulating acupoints by using burned moxa
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Stimulating acupoints by using stainless steel needles without manual manipulation.
Primary Outcome Measure Information:
Title
Chalder's Fatigue Scale Score(CFSS)
Description
In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Numeric Rating Scale(NRS)
Description
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
Title
36-item Short-Form Health Survey (SF-36)
Description
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
Title
Deficiency of Qi Scale Score (DQSS)
Description
In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'.
Time Frame
Two years
Title
Total Power(TP)
Description
Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.
Time Frame
Two years
Title
Low frequency(LF)
Description
Low frequency band (ms²/Hz, %), detected by portable HRV device.
Time Frame
Two years
Title
High frequency (HF)
Description
High frequency band (ms²/Hz, %), detected by portable HRV device.
Time Frame
Two years
Title
LF/HF
Description
Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.
Time Frame
Two years
Title
Ultra-low frequency(ULF)
Description
Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.
Time Frame
Two years
Title
Very low frequency
Description
Very low frequency band (ms²/Hz, %),,detected by portable HRV device.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The patients meeting criteria of CFS; Aged from 18-65; With no skin lesions for the acupuncture area; Sign on the Informed Consent Form; Exclusion Criteria: Patients who can't accept and are afraid of acupuncture in the acupuncture group. 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. Persons suffering from a mental disease, Alzheimer's disease or cancer. Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation. Pregnant women and nursing mothers. Persons suffering from thrombocytopenia and abnormalities of blood coagulation function. Persons with alcohol and drug abuse history.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang feng xia, Doctor
Phone
+86 18971371818
Email
315938821@qq.com
Facility Information:
Facility Name
Hubei university of TCM
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

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