Clinical trial NCT05749757: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Post COVID-19 Condition
Fatigue
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The change from baseline in the Chalder Fatigue Scale (CFS) score
timeFrame: Week 4
Secondary outcomes:
measure: The change from baseline in the Chalder Fatigue Scale (CFS) score
timeFrame: Weeks 8, 12, and 16
measure: Proportion of participants with a score of less than 15 on CFS
timeFrame: Weeks 4, 8, 12, and 16
measure: The change from baseline in the distance of Six-Minute Walk Test (6MWT).
timeFrame: Weeks 4, 8 and 16
measure: The proportion of participants rated as "very much improved" or "much improved" based on the Patient Global Impression-Change (PGI-C).
timeFrame: Weeks 4, 8, 12, and 16
measure: The change from baseline in the score of physical function dimension of Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36).
timeFrame: Weeks 4, 8, 12, and 16
measure: The change from baseline in the score of Chinese Version of the Work and Social Adjustment Scale (CWSAS).
timeFrame: Weeks 4, 8, 12, and 16
measure: The change from baseline in the score of Montreal Cognitive Assessment (MoCA).
timeFrame: Weeks 4 and 16
measure: The change from baseline in the score of Patient Health Questionnaire-15 (PHQ-15) score.
timeFrame: Weeks 4 and 16
measure: The change from baseline in the score of Physical Health Questionnaire-9 (PHQ-9)
timeFrame: Weeks 4 and 16
measure: The change from baseline in the score of General Anxiety Disorder-7 (GAD-7).
timeFrame: Weeks 4 and 16
measure: The change from baseline in the score of Insomnia Severity Index (ISI).
timeFrame: Weeks 4, 8, 12, and 16
Other outcomes:
measure: Expectance assessment
timeFrame: Baseline
measure: Blinding assessment
timeFrame: Within 5 minutes after the either treatment in week 4
Locations:
Study officials:
References: