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Exercise-Induced Muscle FatigueHILTNCT07895862

Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults

A study of Exercise-Induced Muscle Fatigue and Fatigue Recovery, run by University of Primorska.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 18 to 40 years.
  • Willingness to participate and provide written informed consent.

Who cannot join

  • Acute or chronic injuries of the upper limbs.
  • Neurological, musculoskeletal, or systemic diseases that could affect muscle function.
  • Contraindications to high-intensity laser therapy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Denisa Manojlović Ivezić, PhD contact

+385989394672

denisa.manojlovic@fvz.upr.si

About this study

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:

Read more

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.

Being tested
High-Intensity Laser Therapy (HILT) and sham HILT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Intensity Laser Therapy (HILT) and sham HILTDevice

    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.

Study groups in NCT07895862
Study groupRoleWhat they receive
Active HILT Followed by Placebo HILTExperimentalHigh-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.
Receives: Device: High-Intensity Laser Therapy (HILT) and sham HILT
Sham HILT Followed by Placebo HILTSham comparatorSham 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.
Receives: Device: High-Intensity Laser Therapy (HILT) and sham HILT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Handgrip Strength

    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.

    Measured: 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.

Secondary outcomes (1)
  1. Wrist Flexor Muscle Stiffness

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895862
Sponsor's protocol ID
HILT effects_forearm
Acronym
HILT
Status last verified
Aug 2026
First submitted
19 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study of Exercise-Induced Muscle Fatigue and Fatigue Recovery, run by University of Primorska.

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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Denisa Manojlović Ivezić, PhD (+385989394672, denisa.manojlovic@fvz.upr.si), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Handgrip Strength (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2026.

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