Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients

NCT04959747 | Unknown DMC

• 1 other identifier: Acupuncture for OD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfactory Dysfunction; Covid19

Keywords

olfactory dysfunction; acupuncture; COVID-19; randomized; sham controlled trial

Outcome Measures

Primary Outcomes (2)

• 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)

  1, 6, 8, 12, 14 weeks

• 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.

  1, 6, 8, 12, 14 weeks

Secondary Outcomes (1)

• UPSIT-TC

  0, 14 weeks

Study Arms (2)

acupuncture group

EXPERIMENTAL

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

sham-acupuncture group

PLACEBO COMPARATOR

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

Interventions

acupuncture OTHER

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.

acupuncture group; sham-acupuncture group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Tseung Kwan O Hospital, Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

COVID-19

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Chi Fung CHO, Dr.

  Department of Medicine, Tseung Kwan O Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Zhong, MD., Ph.D

CONTACT

852-34116523; ldzhong0305@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: single blinded, randomized sham controlled, cross-over clinical trial

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 13, 2021
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be shared within 7 years of the completion of this study.
• Access Criteria: By requirement

Locations

HK (1)