Back to resultsAcupuncture for Post COVID-19 Fatigue
Primary Purpose
Acupuncture, Post COVID-19 Condition, Fatigue
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture
Eligibility Criteria
Inclusion Criteria: Patients aged between 18 and 75. Confirmed COVID-19 infection in the past four weeks to six months, and a negative RT PCR and/or Antigen-Based Rapid Test at present. A main complaint of fatigue emerged newly following COVID-19 infection. A score of ≥15 on Chalder Fatigue Scale (CFS, score range 0-33). Participating the trial volunteerly and providing written informed consent. Exclusion Criteria: Severe anxiety and depression: a score of ≥25 on 17-item Hamilton Rating Scale for Depression (HAMD-17) and/or a score scores >29 on 14-item Hamilton Rating Scale for Anxiety (HAMA-14). Significant cognitive dysfunction or suicidal tendency. Usage of anti-anxiety and/or anti-depression treatments over the last three months. Previously diagnosed hypothyroidism or chronic fatigue syndrome. A complication of serious and poorly controlled underlying diseases. Having symptoms indicating emergency or severe conditions. Concurrent use of other anti-fatigue agents or treatments at present. Impaired walking ability. Pregnant and/or lactating or planning to get pregnant in the next 4 months.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture
Sham Acupuncture
Arm Description
Hwato brand disposable acupuncture needles (size 0.30 × 40 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.
Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session sham acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.
Outcomes
Primary Outcome Measures
The change from baseline in the Chalder Fatigue Scale (CFS) score
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
Secondary Outcome Measures
The change from baseline in the Chalder Fatigue Scale (CFS) score
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
Proportion of participants with a score of less than 15 on CFS
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
The change from baseline in the distance of Six-Minute Walk Test (6MWT).
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
The proportion of participants rated as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C).
PGI-C is a 7-point scale, reted by participants themselves, to assess their overall improvement as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse".
The change from baseline in the score of physical function dimension of Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36).
Physical functioning of SF-36 is used to assess the health-related quality of life (HRQoL). Physical functioning dimension consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate better HRQoL related to physical functioning.
The change from baseline in the score of Chinese Version of the Work and Social Adjustment Scale (CWSAS).
The CWSAS assesses the impairment of social function in five items of ability to work, home management, social leisure, private leisure, and close relationship. Each item is rated on a 9-point Likert scale from 0 (no impairment) to 8 (very severe impaired). The total score of the scale ranges from 0 to 40, with higher scores indicating more severe psychopathology.
The change from baseline in the score of Montreal Cognitive Assessment (MoCA).
The MoCA is used for rapid assessment of mild cognitive impairment. It consists of 12 subtasks exploring the cognitive domains of memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, temporal and spatial orientation. The total score ranges from 0 (worst performance) to 30 (best performance) and the normal score is no less than 26.
The change from baseline in the score of Patient Health Questionnaire-15 (PHQ-15) score.
PHQ-15 is a self-administered test to assess somatization disorder. It comprises 15 items, and each item scores from 0 ("not bothered at all") to 2 ("bothered a lot").
The change from baseline in the score of Physical Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a nine-item self-rated questionnaire to measure the severity of depressive symptoms over the last two weeks corresponding to the DSM-IV criteria of major depressive disorder. Each item is scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater severity of depressive symptoms.
The change from baseline in the score of General Anxiety Disorder-7 (GAD-7).
The GAD-7 is a seven-item self-rated questionnaire to assess the severity of generalized anxiety disorder over the last two weeks according to DSM-IV diagnostic criteria. Each item is rated from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater severity of anxiety symptoms.
The change from baseline in the score of Insomnia Severity Index (ISI).
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale (0-4) is used to rate each item and the total score of ISI ranges from 0 to 28. Higher scores indicate more severe insomnia.
Full Information
NCT ID
NCT05749757
First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05749757
Brief Title
Acupuncture for Post COVID-19 Fatigue
Official Title
The Efficacy and Safety of Acupuncture for Post COVID-19 Fatigue: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Post COVID-19 Condition, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Hwato brand disposable acupuncture needles (size 0.30 × 40 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
Hwato brand disposable placebo needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) and adhesive pads will be used. Acupoints of Guanyuan, Zhongwan, Tianshu, Zusanli, Taixi, Shangyintang, Taiyang, Hegu, Taichong and Shenmen will be selected. Participants will receive a total of 10-session sham acupuncture treatment during four weeks, three times a week in the first two weeks and twice a week in the last two weeks.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
For Shangyitang acupoint, the needle will be inserted towards the direction of nasal tip horizontally to a depth of 10-20mm without any manipulation, and a pad will be adhered afterwards. For other acupoints, the needles will be inserted through adhesive pads to 10-20mm. Needles will be lifted, thrust, and twirled for 3 times to achieve deqi sensation, and will be manipulated every ten minutes during 30-minute maintenance.
Intervention Type
Device
Intervention Name(s)
Sham Acupuncture
Intervention Description
For all the points, the needles will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrust and twirled for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
Primary Outcome Measure Information:
Title
The change from baseline in the Chalder Fatigue Scale (CFS) score
Description
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
The change from baseline in the Chalder Fatigue Scale (CFS) score
Description
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
Time Frame
Weeks 8, 12, and 16
Title
Proportion of participants with a score of less than 15 on CFS
Description
CFS evaluates physical and mental fatigue with two subscales and 11 items. Total fatigue score is obtained by summing 11 items, which were rated on a four-point Likert scale (0=better than usual, 1=no worse than usual, 2=worse than usual, and 3=much worse than usual). Higher scores indicate more severe fatigue.
Time Frame
Weeks 4, 8, 12, and 16
Title
The change from baseline in the distance of Six-Minute Walk Test (6MWT).
Description
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Time Frame
Weeks 4, 8 and 16
Title
The proportion of participants rated as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C).
Description
PGI-C is a 7-point scale, reted by participants themselves, to assess their overall improvement as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse".
Time Frame
Weeks 4, 8, 12, and 16
Title
The change from baseline in the score of physical function dimension of Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36).
Description
Physical functioning of SF-36 is used to assess the health-related quality of life (HRQoL). Physical functioning dimension consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate better HRQoL related to physical functioning.
Time Frame
Weeks 4, 8, 12, and 16
Title
The change from baseline in the score of Chinese Version of the Work and Social Adjustment Scale (CWSAS).
Description
The CWSAS assesses the impairment of social function in five items of ability to work, home management, social leisure, private leisure, and close relationship. Each item is rated on a 9-point Likert scale from 0 (no impairment) to 8 (very severe impaired). The total score of the scale ranges from 0 to 40, with higher scores indicating more severe psychopathology.
Time Frame
Weeks 4, 8, 12, and 16
Title
The change from baseline in the score of Montreal Cognitive Assessment (MoCA).
Description
The MoCA is used for rapid assessment of mild cognitive impairment. It consists of 12 subtasks exploring the cognitive domains of memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, temporal and spatial orientation. The total score ranges from 0 (worst performance) to 30 (best performance) and the normal score is no less than 26.
Time Frame
Weeks 4 and 16
Title
The change from baseline in the score of Patient Health Questionnaire-15 (PHQ-15) score.
Description
PHQ-15 is a self-administered test to assess somatization disorder. It comprises 15 items, and each item scores from 0 ("not bothered at all") to 2 ("bothered a lot").
Time Frame
Weeks 4 and 16
Title
The change from baseline in the score of Physical Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a nine-item self-rated questionnaire to measure the severity of depressive symptoms over the last two weeks corresponding to the DSM-IV criteria of major depressive disorder. Each item is scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater severity of depressive symptoms.
Time Frame
Weeks 4 and 16
Title
The change from baseline in the score of General Anxiety Disorder-7 (GAD-7).
Description
The GAD-7 is a seven-item self-rated questionnaire to assess the severity of generalized anxiety disorder over the last two weeks according to DSM-IV diagnostic criteria. Each item is rated from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater severity of anxiety symptoms.
Time Frame
Weeks 4 and 16
Title
The change from baseline in the score of Insomnia Severity Index (ISI).
Description
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale (0-4) is used to rate each item and the total score of ISI ranges from 0 to 28. Higher scores indicate more severe insomnia.
Time Frame
Weeks 4, 8, 12, and 16
Other Pre-specified Outcome Measures:
Title
Expectance assessment
Description
Participants will be asked what do you think the condition of fatigue will be in a month?
Time Frame
Baseline
Title
Blinding assessment
Description
Participants will be asked do you think you have received traditional acupuncture over the past 4 weeks.
Time Frame
Within 5 minutes after the either treatment in week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged between 18 and 75.
Confirmed COVID-19 infection in the past four weeks to six months, and a negative RT PCR and/or Antigen-Based Rapid Test at present.
A main complaint of fatigue emerged newly following COVID-19 infection.
A score of ≥15 on Chalder Fatigue Scale (CFS, score range 0-33).
Participating the trial volunteerly and providing written informed consent.
Exclusion Criteria:
Severe anxiety and depression: a score of ≥25 on 17-item Hamilton Rating Scale for Depression (HAMD-17) and/or a score scores >29 on 14-item Hamilton Rating Scale for Anxiety (HAMA-14).
Significant cognitive dysfunction or suicidal tendency.
Usage of anti-anxiety and/or anti-depression treatments over the last three months.
Previously diagnosed hypothyroidism or chronic fatigue syndrome.
A complication of serious and poorly controlled underlying diseases.
Having symptoms indicating emergency or severe conditions.
Concurrent use of other anti-fatigue agents or treatments at present.
Impaired walking ability.
Pregnant and/or lactating or planning to get pregnant in the next 4 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanjie Sun
Phone
86 18810337542
Email
puzhisun@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data and data dictionary will be available with publication until six months after publication.
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
IPD Sharing Time Frame
The data will be available with publication until until six months after publication.
IPD Sharing Access Criteria
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved.
Researchers whose proposal has been approved will sign a data access agreement.
Learn more about this trial
Acupuncture for Post COVID-19 Fatigue
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