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

B

Beni-Suef University

Status

Completed

Conditions

COVID 19 Disease

Treatments

Radiation: Photobiomodulation
Other: telerehabilitation
Device: traditional chest physiotherapy
Procedure: Myofascial release therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06795841
FBTBSUREC/2052020 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

45 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

102 participants in 3 patient groups

Photobiomodulation therapy
Experimental group
Description:
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
Treatment:
Other: telerehabilitation
Radiation: Photobiomodulation
Myofascial release therapy
Experimental group
Description:
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
Treatment:
Procedure: Myofascial release therapy
Other: telerehabilitation
traditional physical therapy program
Experimental group
Description:
included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles )
Treatment:
Device: traditional chest physiotherapy
Other: telerehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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