New Modality for Post Covid Syndrome Patients

Effect of Laser Acupuncture on Immunological Response and Dyspnea in Post Covid Syndrome Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Covid Syndrome
• Intervention / Treatment: Device: laser acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: salma alghitany, PHD degree; Phone Number: 00201229723881; Email: fardreams@yahoo.com
• Study Contact Backup: Name: sandra girguis, PHD degree; Phone Number: 00201221426663; Email: sandra_sweety@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group(1); 40 post covid 19 patients will receive laser acupuncture	Device: laser acupuncture; 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
Placebo Comparator: group(2); 40 post covid patients will receive placebo laser acupuncture in which laser will be off	Device: laser acupuncture; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in fatigability	chalder fatigue scale is 11 items scale. people of 4 or more are considered meeting the criteria of fatigue	after 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: shawky fouad, PHD degree, Cairo University; Principal Investigator: sandra girguis, PHD degree, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: P.T.REC/012/003582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No