- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Denisa Manojlović Ivezić, PhD
- Telefonní číslo: +385989394672
- E-mail: denisa.manojlovic@fvz.upr.si
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Falešný srovnávač: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Handgrip Strength
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Wrist Flexor Muscle Stiffness
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- HILT effects_forearm
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