COVID 19 DiseasePBM in COVID19NCT06795841
Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With COVID-19 With Follow-Up Telerehabilitation
A study testing Photobiomodulation, Myofascial release therapy and traditional chest physiotherapy in people with COVID 19 Disease, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- COVID 19 Disease
- What is being tested?
- Photobiomodulation, Myofascial release therapy and traditional chest physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Severe electrolyte imbalance
- Acute Venous Thromboembolism (VTE) without therapeutic anticoagulation for over 48 hours,
- Unstable Atrial fibrillation , or Severe Tachycardia compared to baseline.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy , Beni-Suef University
Banī Suwayf, 62511
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- COVID 19 Disease
- Being tested
- Photobiomodulation, Myofascial release therapy, traditional chest physiotherapy, telerehabilitation
- Keywords
- COVID19, Photobiomodulation, Myofascial release
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
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
Myofascial release therapyProcedure or surgery
technique was applied from supine position, with both hands cupping both diaphragmatic domes
traditional chest physiotherapyDevice
included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise
telerehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation therapy | Experimental | 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 Receives: Radiation: Photobiomodulation; Other: telerehabilitation |
| Myofascial release therapy | Experimental | 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 Receives: Procedure: Myofascial release therapy; Other: telerehabilitation |
| traditional physical therapy program | Experimental | included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles ) Receives: Device: traditional chest physiotherapy; Other: telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lab Investigations
(1) ferritin
Measured: at baseline and at discharge from ICU up to 14 days and at 3 month of discharge
lab investigation
- D-dimer
Measured: at baseline and at icu discharge up to 14 days and at 3 months of discharge
Secondary outcomes (11)
lab analysis
(3) CRP
Measured: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
lab analysis
(4) Interleukin-6
Measured: at baseline and at icu discharge up to 14 days and at 3 months of discharge
lab analysis
(5) white blood cell counts.
Measured: at baseline and at icu discharge up to 14 days and at 3 months of discharge
Maximum inspiratory pressure
Maximum inspiratory pressure
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Icu length of stay
Measured: 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.
Measured: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Lower limbs strength
Quadriceps strength
Measured: at baseline and at ICU discharge upto 14 days and at 3 months of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Jun 2020
- Primary completion15 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID 19 DiseaseStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherin Hassan Mohammed Mehani, Beni-Suef University
- Investigators
- Mahmoud Ibrahim Mahmoud, Lecturer, Principal investigator, Faculty of Physical Therapy - Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795841
- Sponsor's protocol ID
- FBTBSUREC/2052020
- Other IDs
- FBTBSUREC/2052020
- Acronym
- PBM in COVID19
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 38638386
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With Moderate COVID 19 Inside Intensive Care Unit, With a Complementary Home Telerehabilitation
- ClinicalTrials.gov ID
- NCT06795841
- Acronym / sponsor ID
- PBM in COVID19 / FBTBSUREC/2052020
- Conditions
- COVID 19 Disease
- Keywords
- COVID19, Photobiomodulation, Myofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation therapy | Experimental | Radiation: Photobiomodulation, Other: telerehabilitationPhotobiomodulation 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 |
| Myofascial release therapy | Experimental | Procedure: Myofascial release therapy, Other: telerehabilitationMyofascial 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 |
| traditional physical therapy program | Experimental | Device: traditional chest physiotherapy, Other: telerehabilitationincluded traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles ) |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Patients on Invasive Mechanical Ventilation
- Hemodynamically Unstable with inotropic support
- Septic Shock
- ICU admission less than 24 h
- physician termination of physiotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationIt 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 | Radiation | Photobiomodulation therapy |
| Myofascial release therapytechnique was applied from supine position, with both hands cupping both diaphragmatic domes | Procedure or surgery | Myofascial release therapy |
| traditional chest physiotherapyincluded traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise | Device | traditional physical therapy program |
| telerehabilitationFollowing 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 | Other | Myofascial release therapy, Photobiomodulation therapy, traditional physical therapy program |
Primary outcome
Lab Investigations
Time frame: at baseline and at discharge from ICU up to 14 days and at 3 month of discharge
(1) ferritin
lab investigation
Time frame: at baseline and at icu discharge up to 14 days and at 3 months of discharge
2. D-dimer
11 secondary outcomes
lab analysis
Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
lab analysis
Time frame: at baseline and at icu discharge up to 14 days and at 3 months of discharge
lab analysis
Time frame: at baseline and at icu discharge up to 14 days and at 3 months of discharge
Maximum inspiratory pressure
Time frame: at baseline and at icu discharge upto 14 days and at 3 months of discharge
Six-minute walk test
Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Ease of breathing
Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Dyspnea perception
Time frame: at baseline and at ICU discharge, up to 14 days and at 3 months of discharge
Percentage of oxygen saturation
Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Icu length of stay
Time frame: at ICU discharge up to 2weeks
fatigue
Time frame: at baseline and at ICU discharge up to 14 days and at 3 months of discharge
Lower limbs strength
Time frame: at baseline and at ICU discharge upto 14 days and at 3 months of discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 38638386Azadeh 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.
- Light as a Cure in COVID-19: A Challenge for MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Ibrahim Mahmoud, Lecturer principal investigator
Faculty of Physical Therapy - Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation, Myofascial release therapy and traditional chest physiotherapy in people with COVID 19 Disease, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lab Investigations (time frame: at baseline and at discharge from ICU up to 14 days and at 3 month of discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.