Clinical trial NCT06795841: Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques in Patients with COVID19
Official title: Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques in Patients with Mild to Moderate COVI19 Inside Intensive Care Unit, a Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID 19 Disease
Keywords: COVID19
Photobiomodulation
Myofascial release
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group (A) consisted of 15 patients (men and women) who received medical treatment, traditional physiotherapy, and low-level laser therapy; the intervention group (B) consisted of 15 patients ( men and women) who received medical treatment and traditional physiotherapy and myofascial release techniques; and the control group (C) consisted of 15 patients ( men and women ) who received medical treatment and traditional physiotherapy only.
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effectiveness of low-level laser therapy and myofascial release therapy in reducing inflammation and enhancing functional capacity for patients with coronavirus disease2019 (COVID-19).

Design: This was a single-center, randomized, controlled, parallel-group intervention study.

Participants: Forty five patients with covid 19 , aged 45-60 years (men and women), completed this study and were randomised into three groups: an intervention group(A) (n = 15), Intervention group (B) (n=15) and an control group (C) (n = 15).

Intervention:. The intervention group (A) received medical treatment, traditional physiotherapy, and low-level laser therapy; the intervention group (B) received medical treatment, traditional physiotherapy, and myofascial release techniques; and the control group (C) received medical treatment and traditional physiotherapy only.

Main Outcome Measures: Laboratory analysis encompassed a sample obtained from the patient's peripheral vein or Central Venous line to evaluate (I) ferritin, (II) D-dimer, (III) CRP, (IV) Interleukin-6 and (V) white blood cell counts as primary outcomes. Functional capacity as assessed by the Six-minute walk test, dyspnoea as measured by visual analogue scale, and dyspnoea perception as evaluated by the modified Borg scale, length of Intensive care unit stay, and oxygen saturation were the secondary outcome measures.

Detailed description: Forty five COVID 19 patients (24 men and 16 women) aged 45-60 years were recruited from the ALqasr Aleiny Intensive Care Unit.All patients were informed of the study, risks, and expected benefits before signing the informed consent form.The intervention group (A) consisted of 15 patients (men and women) who received medical treatment, traditional physiotherapy, and low-level laser therapy; the intervention group (B) consisted of 15 patients ( men and women) who received medical treatment and traditional physiotherapy and myofascial release techniques; and the control group (C) consisted of 15 patients ( men and women ) who received medical treatment and traditional physiotherapy only.

The eligibility criteria were as follows: (1) Patients aged from 40 to 60 years old, (2) Diagnosed by CT or PCR as positive COVID 19, (3) Moderate to severe cases of COVID-19(According to CO-RADSScale).(4) on low flow rate oxygen supply Exclusion criteria were (1) patients on Invasive Mechanical Ventilation, (2) Hemodynamically Unstable with inotropic support; (3) Septic Shock; (4) ICU admission less than 24 h; (5) physician termination of physiotherapy; and (6) fever with causes other than chest infection.

* (7) severe electrolyte imbalance, Acute Venous Thromboembolism (VTE) without therapeutic anticoagulation for over 48 hours, (8) Unstable Atrial fibrillation (A.F.), or Severe Tachycardia compared to baseline.

Eligibility criteria: Inclusion Criteria:

* The eligibility criteria were as follows:
* Patients aged from 40 to 60 years old.
* Diagnosed by CT or PCR as positive COVID 19.
* Moderate to severe cases of COVID-19(According to CO-RADSScale).
* On low flow rate oxygen supply

Exclusion Criteria:

* Patients on Invasive Mechanical Ventilation
* Hemodynamically Unstable with inotropic support
* Septic Shock
* ICU admission less than 24 h
* physician termination of physiotherapy;
* Fever with causes other than chest infection.
* Severe electrolyte imbalance
* Acute Venous Thromboembolism (VTE) without therapeutic anticoagulation for over 48 hours,
* Unstable Atrial fibrillation (A.F.), or Severe Tachycardia compared to baseline.

Primary outcomes:
measure: Lab Investigations
timeFrame: before starting the rehabilitation program and after 2 weeks
Secondary outcomes:
measure: Six-minute walk test
timeFrame: before starting the rehabilitation program and after 2 weeks
measure: Ease of breathing
timeFrame: before starting the rehabilitation program and after 2 weeks
measure: Dyspnea perception
timeFrame: before starting the rehabilitation program and after 2 weeks
measure: Percentage of oxygen saturation
timeFrame: before starting the rehabilitation program and after 2 weeks
measure: Icu length of stay
timeFrame: before starting the rehabilitation program and after 2 weeks
Other outcomes:
Locations:
city: Beni-Suef Governorate
country: Egypt
facility: Faculty of Physical Therapy , Beni-Suef University
Study officials:
affiliation: Faculty of Physical Therapy - Beni-Suef University
name: Mahmoud Ibrahim Mahmoud, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azadeh SS, Esmaeeli Djavid G, Nobari S, Keshmiri Neghab H, Rezvan M. Light-Based Therapy: Novel Approach to Treat COVID-19. Tanaffos. 2023 Mar;22(3):279-289.