The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue

NCT06330363 | Completed DMC

• 1 other identifier: METC 23-049
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Low level laser therapy, or photobiomodulation, is getting more attention as a non-invasive treatment strategy for numerous conditions. Phototherapy has been applied for more than 40 years for the treatment of musculoskeletal and neurological conditions. Low level laser therapy generally applies red or near-infrared lasers with a wavelength between 600 and 1000 nm and low power wattage from 5 to 500 mW and a power density between 1 and 5 W/cm2. The laser light is absorbed by the skin without thermal damage and penetrates deeply into tissues where it is supposed to induce its physiological effects at the cellular level. Laser therapy has been hypothesized to stimulate mitochondrial respiration, increase tissue oxygenation, and support tissue regeneration. Despite supportive research data on in vitro cell and in vivo animal data, there are surprisingly few data on the proposed impact of low level laser treatment (LLLT) on tissue metabolism in vivo in humans. Objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults. Secondary objectives include the in vivo assessment of cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity within muscle and skin. Study design: Within-subject study. Study population: 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) adults (6 men and 6 women). Intervention: One leg of the subjects will receive LLLT, while the other leg will receive no treatment. After the treatment muscle and skin biopsy samples will be taken from both legs. Main study parameters/endpoints: The primary outcome will be mitochondrial respiration of the LLLT treated and non-treated leg based on muscle samples. Secondary study parameters are muscle and skin gene expression, protein signalling and enzyme activity.

Conditions

Muscles Metabolism; Skin Metabolism

Outcome Measures

Primary Outcomes (1)

• Muscle mitochondrial respiration

  Maximal complex I+II-linked mitochondrial respiration of muscle tissue, expressed as oxygen consumption (JO2) in units of pmol/sec/mg dry weight muscle. Oxygen consumption will be monitored in an Oroboros O2K Oxygraph (Innsbruck, Austria) in the presence of pyruvate, malate, ADP, glutamate, and succinate, providing substrates to maximally stimulate complex I+II-linked respiration.

  only one time point, immediately after the intervention

Secondary Outcomes (3)

• Gene expression (mRNA) via real-time PCR

  only one time point, immediately after the intervention

• Protein expression via western blotting

  only one time point, immediately after the intervention

• Skin mitochondrial respiration

  only one time point, immediately after the intervention

Study Arms (2)

LLLT

EXPERIMENTAL

The LLLT will be performed using a Cube plus30 (Eltech K-Laser s.r.l., Italy). Settings will be based on manufacturer's guidelines for skin and deep tissue stimulation. The LLLT will take 25 min, with 3x5 min of treatment separated by 5 min of rest. In total 16800 J in form of light energy will be applied (3 x 5600 J). All 4 available wavelength will be used (660, 800, 905 and 970 nm). The randomization procedure to allocate the treated leg will occur via a random-number generator stratified for sex (www.randomization.com) performed by an independent researcher of the research group. During the laser treatment protective goggles (K-Laser Protective Goggles, Eltech K-Laser s.r.l.) need to be worn and will therefore be provided. LLLT will only be applied by trained personal.

Other: Laser therapy

Sham

SHAM COMPARATOR

Sham laser based on the same laser device which emitts only light.

Other: Sham

Interventions

Laser therapy OTHER

The Cube plus30 from Eltech K-Laser s.r.l. (Italy, www.k-laser.com) will be used for LLLT. The laser devices from Eltech K-Laser s.r.l. have been used in (clinical) studies with a variety in patient populations (38-41) and clinical practice (https://resources.k-laser.com.au/medical-laser-clinical-applications). The device is a registered medical device in the EU confirmed by Kiwa Cermet Italia.

LLLT

Sham OTHER

The laser device has sham light option that will be used.

Also known as: Light

Sham

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female sex
• Aged between 18 and 35 y inclusive
• BMI between 18.5 and 30 kg/m2

You may not qualify if:

• Participating in a structured (progressive) exercise program or \>4h of vigorous physical activity per week.
• Smoking regularly (i.e. \>5 cigarettes/week)
• Pregnancy
• Hormonal replacement therapy
• Diagnosed musculoskeletal disorders
• Diagnosed metabolic disorders (e.g. diabetes)
• Diagnosed skin disorders
• Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
• Chronic use of anti-coagulants

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

MeSH Terms

Interventions

Laser Therapy; salicylhydroxamic acid; Light

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: One let will receive the laser therapy, the other one will get a sham laser. The person analyzing the samples will be blinded to legs.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject study

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: April 1, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

NL (1)