Electro-acupuncture for Long Covid Neuropsychiatric Symptoms: a Prospective, Randomized Sham-controlled, Double-blinded Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial will be conducted to to investigate the efficacy and safety of electro-acupuncture compared to sham acupuncture for treatment of long covid neuropsychiatric symptoms.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• adults over 18 years of age to 80;
• history of SARS-CoV-2 PCR+ at least 4 weeks prior to study entry; SARS-CoV-2 negative (PCR) at study entry;
• at least one persistent neurological symptom (impaired concentration, headache, sensory disturbances, or depression, or brain fog) that began around the time of the acute COVID-19;
• willing and able to consent, complete all assessment and study procedures.
Locations
Other Locations
Hong Kong Special Administrative Region
Zhong Lidan
RECRUITING
Kowloon Tong
Contact Information
Primary
Linda Zhong, MD., Ph.D
ldzhong0305@gmail.com
852 34116523
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 150
Treatments
Experimental: Electro-acupuncture group
The electro-acupuncture intervention will be conducted for 2 session per week during 16-week treatment duration, and will be followed up for 8 weeks. In this study, 7 acupoints are chosen:GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). The puncture is made in accordance with the standards of traditional Chinese medicine, to a depth of 1 to 3 cm depending on the thickness of the local tissues. The acupoints are subjected to 2-5 Hz electroacupuncture from an electroacupuncture device at an intensity (5 to 10 mA) that can produce a muscle twitch acceptable to the participant.
Sham_comparator: Sham-acupuncture group
For subjects assigned to the sham control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2/ 0.30 x 30mm) will be applied to serve as a sham control at the corresponding non-acupoints, leave 0.5 cun from the corresponding acupoints, with the same stimulation modality. Addtionally, the stimulation will be a pseudo stimulation, which will be given by connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The credibility and validity of this system have been well demonstrated.~.
Related Therapeutic Areas
Sponsors
Leads: Hong Kong Baptist University