Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients

NCT ID: NCT04959747

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-09-30

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.

Conditions

Olfactory Dysfunction; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

acupuncture

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tseung Kwan O Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

Haven of Hope - The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Sai Kung District)

UNKNOWN

Sponsor Role: collaborator

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

Zhong Lidan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi Fung CHO, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Tseung Kwan O Hospital

Locations

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

Countries

Hong Kong

Central Contacts

Linda Zhong, MD., Ph.D

Role: CONTACT

ldzhong0305@gmail.com

852-34116523

Facility Contacts

Linda Zhong, MD,PhD

Role: primary

ldzhong0305@gmail.com

34116523

Other Identifiers

Acupuncture for OD

Identifier Type: -

Identifier Source: org_study_id