Acupuncture for Post COVID-19 Fatigue

Study Overview
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Brief Summary
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The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.

Official Title
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The Efficacy and Safety of Acupuncture for Post COVID-19 Fatigue: a Randomized Controlled Trial

Conditions
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Acupuncture, Post COVID-19 Condition, Fatigue

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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. | Device: Acupuncture<br>* 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.<br>|
| Sham Comparator: Sham Acupuncture<br>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. | Device: Sham Acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 8, 12, and 16 | 
| 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. | Weeks 4, 8, 12, and 16 | 
| 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. | Weeks 4, 8 and 16 | 
| 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. | Weeks 4, 8, 12, and 16 | 
| 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. | Weeks 4, 8, 12, and 16 | 
| 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. | Weeks 4, 8, 12, and 16 | 
| 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. | Weeks 4 and 16 | 
| 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). | Weeks 4 and 16 | 
| 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. | Weeks 4 and 16 | 
| 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. | Weeks 4 and 16 | 
| 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. | Weeks 4, 8, 12, and 16 |