New Modality for Post Covid Syndrome Patients
Effect of Laser Acupuncture on Immunological Response and Dyspnea in Post Covid Syndrome Patients
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Coronavirus (19) is a pandemic that affects many countries allover the world. Many patients experienced symptoms as dyspnea and fatigue after their recovery from coronavirus . These symptoms appear to occur regardless the severity of the infection. In addition, many studies reported change in the inflammatory status and immunity in post covid patients. laser acupuncture is a painless noninvasive modality that is used in treating many diseases. laser acupuncture appear to have a role in relieving symptoms, altering inflammatory status and boosting immunity in post covid patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMarch 9, 2022
March 1, 2022
4 months
March 7, 2022
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
change in the level of CD 3 T cells
5ml of blood will be drawn and serum will be separated. cd3 level will be measured using BD FACS Canto flow cytometer
after 12 weeks of treatment
change in the level of cd4 T cells
cd4 will be measured using BD FACS Canto flow cytometer after blood sample will be separated
after 12 weeks of treatment
change in level of interleukin 4
BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
after 12 weeks of treatment
change in level of interleukin 6
BD FACS Canto flow cytometer with BD CBA human th1/th2 cytokine kit will be used
after 12 weeks of treatment
change in lymphocyte count
BD FACS Canto flow cytometer will be used
after 12 weeks of treatment
change in level of dyspnea
mMRC scale is a five point scale to detect degree of dyspnea while performing physical activity. it is ranged from 0-4
after 12 weeks of treatment
Secondary Outcomes (1)
change in fatigability
after 12 weeks of treatment
Study Arms (2)
group(1)
ACTIVE COMPARATOR40 post covid 19 patients will receive laser acupuncture
group(2)
PLACEBO COMPARATOR40 post covid patients will receive placebo laser acupuncture in which laser will be off
Interventions
gallium-aluminum arsenide diode laser with a continuous wave and a wavelength of 850nm will be used for laser acupuncture. it will be applied for three times per week for 12 weeks
Eligibility Criteria
You may qualify if:
- age will be ranged from 30 to 40 years
- patients were diagnosed as covid 19 by polymerase chain reaction test using nasopharyngeal swap
- patients will be negative polymerase chain reaction test (pcr) with symptoms of dyspnea and fatigue.
- patients will be recruited after 2 weeks post the negative pcr
- patients who want to participate and complete the study till the end
You may not qualify if:
- patients with photosensitivity
- pacemaker plantation pregnant women
- BMI more than 30kg/m2 infection or inflammation at the site of acupuncture laser malignancy uncontrolled diabetes psychiatric disorders or mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Officials
- PRINCIPAL INVESTIGATOR
shawky fouad, PHD degree
Cairo University
- PRINCIPAL INVESTIGATOR
sandra girguis, PHD degree
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- teacher at faculty of physical therapy, Cairo university
Study Record Dates
First Submitted
March 7, 2022
First Posted
March 9, 2022
Study Start
March 15, 2022
Primary Completion
June 30, 2022
Study Completion
July 30, 2022
Last Updated
March 9, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share