Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 112 for:    Chronic Fatigue Syndrome

High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924831
Recruitment Status : Unknown
Verified July 2016 by Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Other: Acupuncture Other: moxibustion Other: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability
Study Start Date : November 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Chalder's Fatigue Scale Score(CFSS) [ Time Frame: Two years ]
    In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.


Secondary Outcome Measures :
  1. Numeric Rating Scale(NRS) [ Time Frame: 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'.

  2. 36-item Short-Form Health Survey (SF-36) [ Time Frame: 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.

  3. Deficiency of Qi Scale Score (DQSS) [ Time Frame: Two years ]
    In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'.

  4. Total Power(TP) [ Time Frame: Two years ]
    Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.

  5. Low frequency(LF) [ Time Frame: Two years ]
    Low frequency band (ms²/Hz, %), detected by portable HRV device.

  6. High frequency (HF) [ Time Frame: Two years ]
    High frequency band (ms²/Hz, %), detected by portable HRV device.

  7. LF/HF [ Time Frame: Two years ]
    Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.

  8. Ultra-low frequency(ULF) [ Time Frame: Two years ]
    Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.

  9. Very low frequency [ Time Frame: Two years ]
    Very low frequency band (ms²/Hz, %),,detected by portable HRV device.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924831


Contacts
Layout table for location contacts
Contact: Liang feng xia, Doctor +86 18971371818 315938821@qq.com

Locations
Layout table for location information
China, Hubei
Hubei university of TCM
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

Layout table for additonal information
Responsible Party: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
ClinicalTrials.gov Identifier: NCT02924831     History of Changes
Other Study ID Numbers: XTCX2016-QXZ
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases