University of Nove de Julho — Biomedical Watch V2

Traitements5programmes

Essais2liés

Publications6liées

SourceDBlocale

Traitements

5

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Photobiomodulation TherapyStroke is a non-progressive and permanent syndrome in adults, with approximately 60% of patients presenting with spastic hemiparesis. Spasticity leads to changes in the physiological pattern of muscle tissue contraction and hemodynamics, and, when left untreated, negatively impacts functionality. Photobiomodulation (PBM) has demonstrated positive effects on tissue regeneration, muscle relaxation, reduction of inflammation, fatigue, and pain relief in various muscular and neurological disorders. Methods: This blinded, randomized, controlled clinical trial aims to evaluate the effects of PBM on triceps surae muscle spasticity in adults with stroke. Forty-two participants with spastic hemiparesis post-stroke will be randomized into two groups: active PBM (850 nm, 200 mW, 4 J/point in the gastrocnemius, 12 points, weekly for 8 weeks) or placebo PBM (same protocol, device switched off). Both groups will receive the institute's standard rehabilitation treatment. Outcomes will be assessed using the Modified Ashworth Scale (MAS), ankle range of motion, presence of pain, amount of antispastic medication in use, contraction strength (by manual examination) muscle oxygenation (by transcutaneous near-infrared spectroscopy), functionality, and the occurrence of adverse events before and after the intervention. At the end of recruitment, comparisons between groups and between time points will be performed and statistically analyzed using a two-way repeated means ANOVA test and the Generalized Estimating Equations (GEE) test. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.	Myopathies	Phase 1/2	Traitement symptomatique		À vérifier
Sham PhotobiomodulationThis double-blind, randomized, sham-controlled clinical trial aims to evaluate the effects of vascular photobiomodulation on blood pressure and vascular function in hypertensive patients treated with losartan. A total of 80 patients using losartan (100 mg/day for at least two months) will be recruited and followed for 4 weeks. Participants will be randomly allocated to either an active photobiomodulation group or a sham control group.	Hypertension	Non applicable	À vérifier	Brazil	À vérifier
Vascular PhotobiomodulationThis double-blind, randomized, sham-controlled clinical trial aims to evaluate the effects of vascular photobiomodulation on blood pressure and vascular function in hypertensive patients treated with losartan. A total of 80 patients using losartan (100 mg/day for at least two months) will be recruited and followed for 4 weeks. Participants will be randomly allocated to either an active photobiomodulation group or a sham control group.	Hypertension	Non applicable	À vérifier	Brazil	À vérifier
Photobiomodulation TherapyStroke is a non-progressive and permanent syndrome in adults, with approximately 60% of patients presenting with spastic hemiparesis. Spasticity leads to changes in the physiological pattern of muscle tissue contraction and hemodynamics, and, when left untreated, negatively impacts functionality. Photobiomodulation (PBM) has demonstrated positive effects on tissue regeneration, muscle relaxation, reduction of inflammation, fatigue, and pain relief in various muscular and neurological disorders. Methods: This blinded, randomized, controlled clinical trial aims to evaluate the effects of PBM on triceps surae muscle spasticity in adults with stroke. Forty-two participants with spastic hemiparesis post-stroke will be randomized into two groups: active PBM (850 nm, 200 mW, 4 J/point in the gastrocnemius, 12 points, weekly for 8 weeks) or placebo PBM (same protocol, device switched off). Both groups will receive the institute's standard rehabilitation treatment. Outcomes will be assessed using the Modified Ashworth Scale (MAS), ankle range of motion, presence of pain, amount of antispastic medication in use, contraction strength (by manual examination) muscle oxygenation (by transcutaneous near-infrared spectroscopy), functionality, and the occurrence of adverse events before and after the intervention. At the end of recruitment, comparisons between groups and between time points will be performed and statistically analyzed using a two-way repeated means ANOVA test and the Generalized Estimating Equations (GEE) test. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.	Myopathies	Phase 1/2	Traitement symptomatique		À vérifier
Vascular PhotobiomodulationThis double-blind, randomized, sham-controlled clinical trial aims to evaluate the effects of vascular photobiomodulation on blood pressure and vascular function in hypertensive patients treated with losartan. A total of 80 patients using losartan (100 mg/day for at least two months) will be recruited and followed for 4 weeks. Participants will be randomly allocated to either an active photobiomodulation group or a sham control group.	Hypertension	Non applicable	À vérifier	Brazil	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Vascular Photobiomodulation	Hypertension	Non applicable	NCT07525310	Photobiomodulation Effects on Blood Pressure and Vascular Function in Treated Hypertensive Patients	RECRUITING
Photobiomodulation Therapy	Myopathies	Phase 1/2	NCT07784231	DarbarIllora — The Use of Photobiomodulation in the Treatment of Spasticity After Stroke.	NOT_YET_RECRUITING

Publications

6

Molécule	Indication / population	Titre	Journal	Date
Vascular Photobiomodulation		Systemic Effects of Vascular Photobiomodulation on Early Macrophage Recruitment During Skeletal Muscle Repair.	Journal of biophotonics
Vascular Photobiomodulation		Effects of Vascular Photobiomodulation on Glycemic Control in Patients With Type II Diabetes Mellitus: A Prospective Single-Arm Clinical Study.	Lasers in surgery and medicine
Vascular Photobiomodulation		Effect of local and vascular photobiomodulation on the success of autogenous bone grafts in the alveolar ridge of patients with cleft lip and palate.	Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery
Sham Photobiomodulation		Acute effects of photobiomodulation therapy applied to respiratory muscles of chronic obstructive pulmonary disease patients: a double-blind, randomized, placebo-controlled crossover trial.	Lasers in medical science
Sham Photobiomodulation		Does photobiomodulation influence the resting-state brain networks in young human subjects?	Experimental brain research
Sham Photobiomodulation		Role of photobiomodulation application frequency in facial rejuvenation: randomized, sham-controlled, double-blind, clinical trial.	Lasers in medical science