Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques in Patients with COVID19

Not Applicable

Completed

• Conditions: COVID 19 Disease

• Registration Number: NCT06795841
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lab Investigations	before starting the rehabilitation program and after 2 weeks	evaluate (1) ferritin, (2) D-dimer, (3) CRP, (4) Interleukin-6 and (5) white blood cell counts.

Secondary Outcome Measures

Name	Time	Method
Six-minute walk test	before starting the rehabilitation program and after 2 weeks	The 6-minute walk test (6-MWT) was conducted in the intensive care unit under the supervision
Dyspnea perception	before starting the rehabilitation program and after 2 weeks	It was assessed during a six-minute walking test
Percentage of oxygen saturation	before starting the rehabilitation program and after 2 weeks
Ease of breathing	before starting the rehabilitation program and after 2 weeks	It was assessed using visual analogue scale
Icu length of stay	before starting the rehabilitation program and after 2 weeks

Trial Locations

Locations (1)

Faculty of Physical Therapy , Beni-Suef University; 🇪🇬 Beni-Suef Governorate, Egypt