AcupunctureNCT05749757
Acupuncture for Post COVID-19 Fatigue
A study testing Acupuncture in people with Acupuncture and Post COVID-19 Condition, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupuncture, Post COVID-19 Condition, Fatigue
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Acupuncture for Post COVID-19 Fatigue: a Randomized Controlled Trial
The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.
- Conditions
- Acupuncture, Post COVID-19 Condition, Fatigue
- Being tested
- Acupuncture, Sham Acupuncture
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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.
Sham AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | 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. Receives: Device: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 4, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749757
- Sponsor's protocol ID
- 2023-013-KY-01
- Status last verified
- Feb 2023
- First submitted
- 28 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Acupuncture for Post COVID-19 Fatigue: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05749757
- Acronym / sponsor ID
- 2023-013-KY-01
- Conditions
- Acupuncture, Post COVID-19 Condition, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureHwato 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. |
| Sham Acupuncture | Sham comparator | Device: Sham AcupunctureHwato 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureFor 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. | Device | Acupuncture |
| Sham AcupunctureFor 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. | Device | Sham Acupuncture |
Primary outcome
The change from baseline in the Chalder Fatigue Scale (CFS) score
Time frame: Week 4
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.
11 secondary outcomes
The change from baseline in the Chalder Fatigue Scale (CFS) score
Time frame: Weeks 8, 12, and 16
Proportion of participants with a score of less than 15 on CFS
Time frame: Weeks 4, 8, 12, and 16
The change from baseline in the distance of Six-Minute Walk Test (6MWT).
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).
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).
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).
Time frame: Weeks 4, 8, 12, and 16
The change from baseline in the score of Montreal Cognitive Assessment (MoCA).
Time frame: Weeks 4 and 16
The change from baseline in the score of Patient Health Questionnaire-15 (PHQ-15) score.
Time frame: Weeks 4 and 16
The change from baseline in the score of Physical Health Questionnaire-9 (PHQ-9)
Time frame: Weeks 4 and 16
The change from baseline in the score of General Anxiety Disorder-7 (GAD-7).
Time frame: Weeks 4 and 16
The change from baseline in the score of Insomnia Severity Index (ISI).
Time frame: Weeks 4, 8, 12, and 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture and Post COVID-19 Condition, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanjie Sun (86 18810337542, puzhisun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the Chalder Fatigue Scale (CFS) score (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.