An interventional study of Near-infrared photobiomodulation (NIR PBM) and Sham Placebo in Local Skin Blood Flow, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Other
This study investigated whether near-infrared photobiomodulation (PBM), a non-invasive light therapy, can consistently increase blood flow in the skin of healthy adults. Participants attended two identical study sessions in which they received both active PBM treatment and a placebo treatment using the same device with the light turned off. A subgroup of participants also completed a heat-control session to determine whether any changes in blood flow were caused by the light itself or by heat from the device.
Exclusion Criteria:
Near Infrared PBM
Device: Near-infrared photobiomodulation (NIR PBM)
Inactive light - no near infrared applied
Device: Sham Placebo
Heat Control
Device: Control (heat)
Near-infrared photobiomodulation delivered using a modified Anodyne® Therapy System (Model 120). Device parameters included 890 nm wavelength, irradiance of 5.1 mW/cm², radiant exposure of 4.6 J/cm² and total radiant energy of 35.9 J. The intervention consisted of ten cycles of 3 minutes ON followed by 2-minute OFF intervals.
Identical device placement and treatment schedule with the LEDs deactivated. No near-infrared light was delivered.
The modified device was wrapped in aluminium foil to prevent near-infrared light from reaching the skin while allowing conductive heat transfer. The protocol was otherwise identical to the active intervention.
Reproducibility of NIR-induced change in local skin blood flow between two experimental sessions
Local skin blood flow was measured using laser Doppler flowmetry and expressed as blood perfusion units (BPU). A 5-minute baseline measurement was obtained before exposure. This was followed by ten consecutive 5-minute cycles, consisting of 3 minutes of near-infrared (NIR) exposure followed by 2 minutes without NIR exposure, during which skin blood flow was recorded. After completion of the tenth cycle (50 minutes), NIR exposure was discontinued and skin blood flow was recorded for an additional 15 minutes to assess if the blood flow response lasts post NIR exposure. The outcome was expressed as percent change in skin blood flow relative to baseline. Reproducibility was assessed by comparing the percent change from baseline between the two experimental sessions following the same protocol (Day1 Vs Day2).
Time frame: Day 1 and Day 2 (5-minute baseline, 50-minute NIR intervention period, and 15-minute post-intervention assessment).
change in local skin temperature relative to baseline.
Local skin temperature was measured at the intervention site before the start of the intervention and immediately after completion of the 50-minute intervention period. The change in local skin temperature was calculated relative to the baseline measurement. Measurements were performed using the same protocol on Day 1 and Day 2.
Time frame: Day 1 and Day 2 (baseline and immediately after the 50-minute intervention period).
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Norwegian University of Science and Technology