Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With COVID-19 With Follow-Up Telerehabilitation (PBM in COVID19)

Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With Moderate COVID 19 Inside Intensive Care Unit, With a Complementary Home Telerehabilitation

Objective: To compare low-level laser therapy and myofascial release in reducing inflammation and functional recovery in critically ill COVID-19 patients with 3-month home-based telerehabilitation assessment.

Participants: One hundred two COVID-19 patients aged 45-60 years randomized into three groups: low-level laser therapy (n=34), myofascial release (n=34), and control (n=34).

Intervention: Intensive care unit-based low-level laser therapy, myofascial release, or standard physiotherapy with medical treatment. Following discharge, all participants received 12 weeks of multidimensional home-based telerehabilitation incorporating patient education, breathing exercises, inspiratory muscle training, limb strengthening, aerobic training, and trunk control.

Outcomes: Primary outcomes were ferritin and D-dimer levels. Secondary outcomes included C-reactive protein, interleukin-6, white blood cell counts, maximum inspiratory pressure, six-minute walk test, bilateral knee strength, dyspnea perception, fatigue severity, and oxygen saturation. All measured at baseline, discharge, and 3 months. Intensive care unit length of stay and physiotherapy sessions measured at discharge.

Study Overview

• Status: Completed
• Conditions: COVID 19 Disease
• Intervention / Treatment: Procedure: Myofascial release therapy; Device: traditional chest physiotherapy; Radiation: Photobiomodulation; Other: telerehabilitation

Detailed Description

One hundred-two COVID 19 patients (56 men and 46 women) aged 45-60 years were recruited from the Al Kasr Al Ainy teaching hospitals ICUs. All patients were informed of the study, risks, and expected benefits before signing the informed consent form. The low-level laser therapy group (LLLT) consisted of 34 patients, who received low-level laser therapy, traditional physiotherapy, medical treatment and the myofascial release group (MR) consisted of 34 patients, who received myofascial release techniques, traditional physiotherapy, and medical treatment; and the control group (C) consisted of 34 patients, who received traditional physiotherapy and medical treatment only. After discharge all patients received home multidimension telerehabilitation program.

The eligibility criteria were as follows: (I) Patients aged from 45 to 60 years old, (II) Diagnosed by CT or PCR as positive COVID 19, (III) Moderate cases of COVID-19 (According to CO-RA DS Scale).22 (IV) on low flow rate oxygen supply Exclusion criteria were (I) patients on Invasive Mechanical Ventilation, (II) Hemodynamically Unstable with inotropic support; (III) Septic Shock; (IV) ICU admission less than 24 h.

(V) physician termination of physiotherapy; and (VI) fever with causes other than chest infection, (VII) severe electrolyte imbalance, acute venous thromboembolism without therapeutic anticoagulation for over 48 h, (VIII) Unstable Atrial fibrillation, or severe tachycardia compared to baseline.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Faculty of Physical Therapy , Beni-Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The eligibility criteria were as follows:
• Patients aged from 45 to 60 years old.
• Diagnosed by CT or PCR as positive COVID 19.
• Moderate cases of COVID-19(According to CO-RADS Scale).
• 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 , or Severe Tachycardia compared to baseline.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myofascial release therapy; Myofascial release therapy A- Suboccipital release technique B- anterior cervical myofascial release C- Anterior thoracic and sternal myofascial release D- diaphragmatic dome release technique in addition to traditional physical therapy program	Procedure: Myofascial release therapy; technique was applied from supine position, with both hands cupping both diaphragmatic domes; Other: telerehabilitation; Following ICU discharge, all patients participated in a 12-week structured home multidimensional telerehabilitation program delivered via videoconferencing (Zoom or Microsoft Teams) under the remote supervision of a physiotherapist. Sessions were conducted three times per week and incorporated patient education, breathing exercises, inspiratory muscle training (30 -50% MIP), strengthening of upper and lower limb muscle groups (50- 70 % 1RM), aerobic training (40- 60% HRR), and trunk control activities. Safety monitoring was emphasized throughout, with patients instructed to use a pulse oximeter before, during, and after each session. Adherence was assessed by session attendance, exercise diaries, and weekly therapist follow-up
Experimental: traditional physical therapy program; included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles )	Device: traditional chest physiotherapy; included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise; Other: telerehabilitation; Following ICU discharge, all patients participated in a 12-week structured home multidimensional telerehabilitation program delivered via videoconferencing (Zoom or Microsoft Teams) under the remote supervision of a physiotherapist. Sessions were conducted three times per week and incorporated patient education, breathing exercises, inspiratory muscle training (30 -50% MIP), strengthening of upper and lower limb muscle groups (50- 70 % 1RM), aerobic training (40- 60% HRR), and trunk control activities. Safety monitoring was emphasized throughout, with patients instructed to use a pulse oximeter before, during, and after each session. Adherence was assessed by session attendance, exercise diaries, and weekly therapist follow-up
Experimental: Photobiomodulation therapy; Photobiomodulation therapy :Red laser wavelength (630-660 nm), Average power: 50-100 Mw, Dose: 6-10 J/cm2• Area 2-3 minutes/cm2, Sessions: twice -daily, acupuncture Laser Positions: transcutaneous laser therapy	Radiation: Photobiomodulation; It was applied for upper respiratory tract over tonsils, trachea, and main bronchi (bilaterally parasternal at the level of angle of Lewis), upper and lower lung, and at cubital vein; Other: telerehabilitation; Following ICU discharge, all patients participated in a 12-week structured home multidimensional telerehabilitation program delivered via videoconferencing (Zoom or Microsoft Teams) under the remote supervision of a physiotherapist. Sessions were conducted three times per week and incorporated patient education, breathing exercises, inspiratory muscle training (30 -50% MIP), strengthening of upper and lower limb muscle groups (50- 70 % 1RM), aerobic training (40- 60% HRR), and trunk control activities. Safety monitoring was emphasized throughout, with patients instructed to use a pulse oximeter before, during, and after each session. Adherence was assessed by session attendance, exercise diaries, and weekly therapist follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lab Investigations	(1) ferritin	at baseline and at discharge from ICU up to 14 days and at 3 month of discharge
lab investigation	2. D-dimer	at baseline and at icu discharge up to 14 days and at 3 months of discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lab analysis	(3) CRP	at baseline and at ICU discharge up to 14 days and at 3 months of discharge
lab analysis	(4) Interleukin-6	at baseline and at icu discharge up to 14 days and at 3 months of discharge
lab analysis	(5) white blood cell counts.	at baseline and at icu discharge up to 14 days and at 3 months of discharge
Maximum inspiratory pressure	Maximum inspiratory pressure	at baseline and at icu discharge upto 14 days and at 3 months of discharge
Six-minute walk test	The 6-minute walk test (6-MWT) was conducted in the intensive care unit under the supervision	at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Ease of breathing	It was assessed using visual analogue scale: Zero represented deep, comfortable breathing; 10 represented inability to breathe deeply. Scores were recorded on a graduated ruler	at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Dyspnea perception	It was assessed during a six-minute walking test: modified Borg scale (0-10) assessed dyspnea: zero = no dyspnea; 10 = maximum dyspnea ever experienced	at baseline and at ICU discharge, up to 14 days and at 3 months of discharge
Percentage of oxygen saturation	portable intra-hospital patient monitor measured hemoglobin oxygen saturation in arterial blood.	at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Icu length of stay		at ICU discharge up to 2weeks
fatigue	The Fatigue Severity Scale:Nine-item scale with 7-point Likert responses (1=strongly disagree to 7=strongly agree). Total score represents arithmetic mean of item responses.	at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Lower limbs strength	Quadriceps strength	at baseline and at ICU discharge upto 14 days and at 3 months of discharge

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Mahmoud Ibrahim Mahmoud, Lecturer, Faculty of Physical Therapy - Beni-Suef University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Light as a Cure in COVID-19: A Challenge for Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: COVID19; Photobiomodulation; Myofascial release
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Health Services Administration; Delivery of Health Care; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Laser Therapy; Phototherapy; Telemedicine; Patient Care Management; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Low-Level Light Therapy; Telerehabilitation; Myofascial Release Therapy
• Other Study ID Numbers: FBTBSUREC/2052020 (Registry Identifier: Faculty of Physical Therapy = Beni-Suef University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD could be shared in the form of study protocol , full details about study procedure and summary about the results . The sharing is available through the study principal investigator ; Prof. Sherin Mehani for about 12 months after publishing the paper.
• IPD Sharing Time Frame: The sharing is available through the study principal investigator ; Prof. Sherin Mehani for about 12 months after publishing the paper.
• IPD Sharing Access Criteria: All of the interested readers could access the needed IPD and supportive information upon request through E- mail sherinhassin@yahoo.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No