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Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With COVID-19 With Follow-Up Telerehabilitation

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06795841
Acronym
PBM in COVID19
Enrollment
102
Registered
2025-01-28
Start date
2020-06-01
Completion date
2020-12-31
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19 Disease

Keywords

COVID19, Photobiomodulation, Myofascial release

Brief summary

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.

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.

Interventions

RADIATIONPhotobiomodulation

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

technique was applied from supine position, with both hands cupping both diaphragmatic domes

included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise

OTHERtelerehabilitation

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

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Data analyzer

Intervention model description

The intervention group (A) consisted of 34 patients (men and women) who received medical treatment, traditional physiotherapy, and low-level laser therapy; the intervention group (B) consisted of 34 patients ( men and women) who received medical treatment and traditional physiotherapy and myofascial release techniques; and the control group (C) consisted of 34 patients ( men and women ) who received medical treatment and traditional physiotherapy only.After discharge all patients received home multidimension telerehabilitation program for 3 month.

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lab Investigationsat baseline and at discharge from ICU up to 14 days and at 3 month of discharge(1) ferritin
lab investigationat baseline and at icu discharge up to 14 days and at 3 months of discharge2\. D-dimer

Secondary

MeasureTime frameDescription
lab analysisat baseline and at ICU discharge up to 14 days and at 3 months of discharge(3) CRP
Maximum inspiratory pressureat baseline and at icu discharge upto 14 days and at 3 months of dischargeMaximum inspiratory pressure
Six-minute walk testat baseline and at ICU discharge up to 14 days and at 3 months of dischargeThe 6-minute walk test (6-MWT) was conducted in the intensive care unit under the supervision
Ease of breathingat baseline and at ICU discharge up to 14 days and at 3 months of dischargeIt was assessed using visual analogue scale: Zero represented deep, comfortable breathing; 10 represented inability to breathe deeply. Scores were recorded on a graduated ruler
Dyspnea perceptionat baseline and at ICU discharge, up to 14 days and at 3 months of dischargeIt was assessed during a six-minute walking test: modified Borg scale (0-10) assessed dyspnea: zero = no dyspnea; 10 = maximum dyspnea ever experienced
Percentage of oxygen saturationat baseline and at ICU discharge up to 14 days and at 3 months of dischargeportable intra-hospital patient monitor measured hemoglobin oxygen saturation in arterial blood.
Icu length of stayat ICU discharge up to 2weeks
fatigueat baseline and at ICU discharge up to 14 days and at 3 months of dischargeThe 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.
Lower limbs strengthat baseline and at ICU discharge upto 14 days and at 3 months of dischargeQuadriceps strength

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMahmoud Ibrahim Mahmoud, Lecturer

Faculty of Physical Therapy - Beni-Suef University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026