The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
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.
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.
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.
Time frame: Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 4, 8, 12, and 16