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Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04959747
Recruitment Status : Not yet recruiting
First Posted : July 13, 2021
Last Update Posted : July 22, 2021
Sponsor:
Collaborators:
Tseung Kwan O Hospital
Haven of Hope - The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Sai Kung District)
Information provided by (Responsible Party):
Zhong Lidan, Hong Kong Baptist University

Brief Summary:
In this a 12-week, single blinded, randomized sham controlled, and cross-over clinical trial. It will be conducted to explore the safety and efficacy of acupuncture for olfactory dysfunction in infected COVID-19 patients in Hong Kong.

Condition or disease Intervention/treatment Phase
Olfactory Dysfunction Covid19 Other: acupuncture Not Applicable

Detailed Description:
This is a single blinded, randomized sham controlled, and cross-over clinical trial. 40 Post COVID-19 patients presenting to olfactory dysfunction will be recruited. 40 patients will be randomly assigned into 2 groups, the acupuncture group (AC) and the sham acupuncture group (SAC) with 1:1 ratio, for 4-week treatment and 2-week follow-up. After the follow-up, the sham group will be conducted with real acupuncture for another 4 weeks and the real acupuncture group will be conducted with the 4-week sham acupuncture.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: single blinded, randomized sham controlled, cross-over clinical trial
Masking: Single (Participant)
Masking Description: Subjects of both groups will be randomly assigned into 2 groups, the acupuncture group or the control (sham) acupuncture group with 1:1 ratio. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
Primary Purpose: Treatment
Official Title: Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: A Randomized, Sham-controlled Clinical Trial
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: acupuncture group

Subject will be scheduled for a total of 8 sessions of acupuncture treatment, to be done by the 30 minutes for each session, twice per week over a 4-week period.

Body acupuncture will choose eight acupoints as Yingxiang (LI20),Shangxing (GV23), BiTong, Yintang, Hegu. Disposable acupuncture needle (0.25 mm in diameter and 25-30mm in length) are inserted at a depth of 10-25 mm obliquely into scalp acupuncture points (ShangXing, YinTang) and straightly into face/body acupuncture points (Yingxiang, BiTong, Hegu).

We will also deliver electro-acupuncture will be applied to the face points at fast and dispersed waves through electric needle stimulator which is provided by Chinese Medicine Clinic (ES-160 6-Channel Programmable electro-acupuncture) for 30 minutes.

Other: acupuncture

Body acupuncture will choose eight acupoints as Yingxiang (LI20),Shangxing (GV23), BiTong, Yintang, Hegu. Disposable acupuncture needle (0.25 mm in diameter and 25-30mm in length) are inserted at a depth of 10-25 mm obliquely into scalp acupuncture points (ShangXing, YinTang) and straightly into face/body acupuncture points (Yingxiang, BiTong, Hegu).

We will also deliver electro-acupuncture will be applied to the face points at fast and dispersed waves through electric needle stimulator which is provided by Chinese Medicine Clinic (ES-160 6-Channel Programmable electro-acupuncture) for 30 minutes.


Placebo Comparator: sham-acupuncture group
For subjects assigned to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to serve as sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of insertion. Its validity and credibility have been well demonstrated.
Other: acupuncture

Body acupuncture will choose eight acupoints as Yingxiang (LI20),Shangxing (GV23), BiTong, Yintang, Hegu. Disposable acupuncture needle (0.25 mm in diameter and 25-30mm in length) are inserted at a depth of 10-25 mm obliquely into scalp acupuncture points (ShangXing, YinTang) and straightly into face/body acupuncture points (Yingxiang, BiTong, Hegu).

We will also deliver electro-acupuncture will be applied to the face points at fast and dispersed waves through electric needle stimulator which is provided by Chinese Medicine Clinic (ES-160 6-Channel Programmable electro-acupuncture) for 30 minutes.





Primary Outcome Measures :
  1. ASOF scores [ Time Frame: 1, 6, 8, 12, 14 weeks ]
    The Assessment of Self-reported Olfactory Functioning and olfaction related quality of life (ASOF) is a 12-item validated questionnaire, it can be subdivided into three domains: the one-item subjective olfactory capability scale (SOC), the five-item self-reported capability of perceiving specific odors scale (SRP), and the six-item olfactory-related quality of life (ORQ) scale. We proceeded to calculate cutoff scores for the three scales. Patients will be considered to have abnormal olfactory capabilities if the SOC score was equal to or less than 3. Scale from 10 (best possible) to 0 (worst possible-unable to smell). Patients were considered to have problems smelling odors if the SRP score was equal to or less than 2.9 (Scale from 0 to 5) Patients were considered to have smell-related problems in quality of life if the ORQ score was equal to or less than 3.7 (Scale from 0 to 6)

  2. sQOD-NS scores [ Time Frame: 1, 6, 8, 12, 14 weeks ]
    The Short version of the Questionnaire of Olfactory Disorders-Negative Statements (sQOD-NS) is a 7-item patient-reported outcome questionnaire. Patients rated the item proposition from 0 (agree) to 3 (disagree) with total score ranging from 0 (significant impact of olfactory dysfunction on quality of life) to 21 (no impact on quality of life). The sQOD-NS is composed of seven questions including social, eating, annoyance, and anxiety and assessed using a 4-point Likert scale (0-3). A higher score means better olfactory specific quality of life.


Secondary Outcome Measures :
  1. UPSIT-TC [ Time Frame: 0, 14 weeks ]
    The University of Pennsylvania Smell Identification Test (UPSIT) is widely used internationally and the worldwide standard for olfactory testing. UPSIT is a 40-item "scratch and sniff" multiple choice test to assess how well participants can identify different odors. Patients will be required to identify each of the 40 odors from four alternatives listed for each odor. The number of correct responses provided a test score such that patients could be categorized into one of four categories: mild, moderate, severe, or total loss. The test is scored by the number of odors identified correctly to generate a maximum score of 40.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who have been previously diagnosed to be infected with COVID-19 and are discharged from local hospitals with all the follows: 1) post COVID-19 olfactory dysfunction with moderate or severe grades (base on UPSIT-TC scores, the cutoff scores are set at 29.5 for male and 30.5 for female); 2) post COVID-19 olfactory dysfunction who did not undergo treatment; 3) no history of trauma, injury or surgery to head or nose or any bleeding from the nose; 4) aged 18 to 80 years who are able to read and write Chinese.

Exclusion Criteria:

Patients will be excluded if they have one or more of follows: 1) patients with olfactory or gustatory dysfunctions before the COVID-19 epidemic; 2) patients with history of chronic rhinosinusitis or nasal polyposis; 3) history of nasal surgery (including rhino/septoplasty with or without functional endoscopic sinus surgery; 4) Pregnant or breastfeeding women.; 5) Medical history: cancers, conditions that affect the nervous system, such as Parkinson's disease or Alzheimer's disease, and/or any other serious diseases; 6) Unstable medical conditions; 7) Patients who have received acupuncture treatment within one month, 8) Alcoholism or drug abuse in past 1 year; 9) Have needle phobia; 10) Have known history of developing acupuncture related severe adverse reaction.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04959747


Contacts
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Contact: Linda Zhong, MD., Ph.D 852-34116523 ldzhong0305@gmail.com

Locations
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Hong Kong
Linda Zhong
Kowloon Tong, Kowloon, Hong Kong
Contact: Linda Zhong, MD,PhD    34116523    ldzhong0305@gmail.com   
Sponsors and Collaborators
Hong Kong Baptist University
Tseung Kwan O Hospital
Haven of Hope - The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Sai Kung District)
Investigators
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Principal Investigator: Chi Fung CHO, Dr. Department of Medicine, Tseung Kwan O Hospital
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Responsible Party: Zhong Lidan, Assistant Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT04959747    
Other Study ID Numbers: Acupuncture for OD
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The sharing of the research data of individual participants will be available.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will be shared within 7 years of the completion of this study.
Access Criteria: By requirement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhong Lidan, Hong Kong Baptist University:
olfactory dysfunction
acupuncture
COVID-19
randomized
sham controlled trial
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases