- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07895862
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults (HILT)
The goal of this clinical trial is to learn whether high-intensity laser therapy applied before exercise reduces the loss of handgrip strength, muscle stiffness, and pain after a tiring forearm exercise in healthy adults. This therapy delivers laser light through the skin to the underlying tissues.
The main questions this study aims to answer are:
Does laser therapy reduce the loss of handgrip strength after exercise compared with placebo treatment?
Does laser therapy reduce the increase in forearm muscle stiffness after exercise?
Does laser therapy reduce pain after exercise?
Researchers will compare active laser therapy with placebo laser treatment to assess whether the active treatment affects the muscles' response to exercise. Each participant will receive both treatments on separate visits. The order of treatments will be assigned by chance.
Participants will attend two laboratory visits at the Faculty of Health Sciences, University of Primorska, Slovenia. At one visit, they will receive active laser therapy over the muscles that bend the wrist in their dominant forearm. At the other visit, they will receive placebo treatment over the same area.
At each visit, participants will:
Rest before the initial measurements.
Have their handgrip strength, forearm muscle stiffness, and pain measured before treatment.
Receive active laser therapy or placebo treatment.
Wait five minutes before starting the exercise procedure.
Complete a wrist-strength test, then hold a muscle contraction at half of their maximum wrist-bending strength until they can no longer maintain the required force.
Have their handgrip strength, muscle stiffness, and pain measured again immediately after exercise and five and fifteen minutes later.
Handgrip strength will be measured by squeezing a handheld device. Muscle stiffness will be measured using a device that applies a brief, gentle mechanical tap to the skin over the muscle. Participants will rate their pain using a visual scale.
Participants will be asked to avoid strenuous physical activity for at least 24 hours before each visit and to keep their diet and regular supplement use similar before both visits.
The main outcome is the change in handgrip strength from before treatment to after exercise. Changes in muscle stiffness and pain will also be compared between the two treatments. Researchers expect active laser therapy to result in a smaller decrease in handgrip strength and smaller increases in muscle stiffness and pain than placebo treatment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Denisa Manojlović Ivezić, PhD
- Numéro de téléphone: +385989394672
- E-mail: denisa.manojlovic@fvz.upr.si
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Healthy adults aged 18 to 40 years.
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Acute or chronic injuries of the upper limbs.
- Neurological, musculoskeletal, or systemic diseases that could affect muscle function.
- Contraindications to high-intensity laser therapy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Active HILT Followed by Placebo HILT
High-intensity laser therapy will be administered using the Platinum 4 device (Summus Medical Laser) over the wrist flexor muscles of the dominant forearm, from the medial epicondyle of the humerus toward the wrist. All four wavelengths available on the device will be used. Each participant will receive one active treatment session, followed by a five-minute interval before the muscle-fatiguing exercise procedure. Both the participant and the therapist will wear appropriate protective eyewear. |
High-intensity laser therapy will be administered using the Platinum 4 device (Summus Medical Laser) over the wrist flexor muscles of the dominant forearm, from the medial epicondyle of the humerus toward the wrist. All four wavelengths available on the device will be used. Each participant will receive one active treatment session, followed by a five-minute interval before the muscle-fatiguing exercise procedure. Both the participant and the therapist will wear appropriate protective eyewear. Placebo high-intensity laser therapy will be administered over the wrist flexor muscles of the dominant forearm before the same muscle-fatiguing exercise procedure used in the active treatment condition. Each participant will receive one placebo treatment session, followed by a five-minute interval before the exercise procedure. |
|
Comparateur factice: Sham HILT Followed by Placebo HILT
Sham high-intensity laser therapy will be administered over the wrist flexor muscles of the dominant forearm before the same muscle-fatiguing exercise procedure used in the active treatment condition. Each participant will receive one placebo treatment session, followed by a five-minute interval before the exercise procedure. |
High-intensity laser therapy will be administered using the Platinum 4 device (Summus Medical Laser) over the wrist flexor muscles of the dominant forearm, from the medial epicondyle of the humerus toward the wrist. All four wavelengths available on the device will be used. Each participant will receive one active treatment session, followed by a five-minute interval before the muscle-fatiguing exercise procedure. Both the participant and the therapist will wear appropriate protective eyewear. Placebo high-intensity laser therapy will be administered over the wrist flexor muscles of the dominant forearm before the same muscle-fatiguing exercise procedure used in the active treatment condition. Each participant will receive one placebo treatment session, followed by a five-minute interval before the exercise procedure. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Handgrip Strength
Délai: At each of the two study visits: before the intervention (baseline), immediately after the fatiguing exercise, and 5 and 15 minutes after the fatiguing exercise. Visits will be separated by at least one week.
|
Handgrip strength will be measured using a Baseline Lite handheld dynamometer on the dominant hand. Participants will be seated with the upper arm alongside the trunk, the elbow flexed to 90 degrees, the forearm in a neutral position, and the wrist in slight extension and ulnar deviation. Three maximal grip attempts will be performed at each assessment, and the highest value will be used for analysis. Changes from the pre-intervention baseline will be compared between active and placebo high-intensity laser therapy. |
At each of the two study visits: before the intervention (baseline), immediately after the fatiguing exercise, and 5 and 15 minutes after the fatiguing exercise. Visits will be separated by at least one week.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Wrist Flexor Muscle Stiffness
Délai: At each of the two study visits: before the intervention (baseline), immediately after the fatiguing exercise, and 5 and 15 minutes after the fatiguing exercise. Visits will be separated by at least one week.
|
Muscle stiffness will be assessed using the MyotonPRO device at a predefined and marked anatomical measurement site over the wrist flexor muscles of the dominant forearm. The device applies a brief mechanical impulse to the skin and measures the tissue response to calculate muscle stiffness in newtons per meter (N/m). Higher values indicate greater stiffness. Changes from the pre-intervention baseline will be compared between active and placebo high-intensity laser therapy. |
At each of the two study visits: before the intervention (baseline), immediately after the fatiguing exercise, and 5 and 15 minutes after the fatiguing exercise. Visits will be separated by at least one week.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HILT effects_forearm
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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