Back to resultsAcupuncture for Olfactory Dysfunction in Infected COVID-19 Patients
Primary Purpose
Olfactory Dysfunction, Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Olfactory Dysfunction focused on measuring olfactory dysfunction, acupuncture, COVID-19, randomized, sham controlled trial
Eligibility 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.
Sites / Locations
- Linda Zhong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
acupuncture group
sham-acupuncture group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
ASOF scores
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)
sQOD-NS scores
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
UPSIT-TC
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.
Full Information
NCT ID
NCT04959747
First Posted
July 12, 2021
Last Updated
July 17, 2021
Sponsor
Hong Kong Baptist University
Collaborators
Tseung Kwan O Hospital, Hong Kong, Haven of Hope - The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Sai Kung District)
1. Study Identification
Unique Protocol Identification Number
NCT04959747
Brief Title
Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients
Official Title
Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: A Randomized, Sham-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Tseung Kwan O Hospital, Hong Kong, Haven of Hope - The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Sai Kung District)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfactory Dysfunction, Covid19
Keywords
olfactory dysfunction, acupuncture, COVID-19, randomized, sham controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single blinded, randomized sham controlled, cross-over clinical trial
Masking
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.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham-acupuncture group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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 Measure Information:
Title
ASOF scores
Description
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)
Time Frame
1, 6, 8, 12, 14 weeks
Title
sQOD-NS scores
Description
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.
Time Frame
1, 6, 8, 12, 14 weeks
Secondary Outcome Measure Information:
Title
UPSIT-TC
Description
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.
Time Frame
0, 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Zhong, MD., Ph.D
Phone
852-34116523
Email
ldzhong0305@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fung CHO, Dr.
Organizational Affiliation
Department of Medicine, Tseung Kwan O Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linda Zhong
City
Kowloon Tong
State/Province
Kowloon
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Zhong, MD,PhD
Phone
34116523
Email
ldzhong0305@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The sharing of the research data of individual participants will be available.
IPD Sharing Time Frame
The data will be shared within 7 years of the completion of this study.
IPD Sharing Access Criteria
By requirement
Learn more about this trial
Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients
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