Assessing the Safety and Efficacy of a Noninvasive Device in the Management of Musculoskeletal Pain Using Low-Level Light Therapy: Double-Blinded, Randomized, Placebo-Controlled, Multicentric Study.

Background: Musculoskeletal pain significantly impacts quality of life and daily functioning. Light-based therapies, including those using red and infrared wavelengths, have shown potential in pain management due to their anti-inflammatory and tissue healing properties. CURAPOD, a pain management device developed by Litemed, uses a combination of visible red and infrared light for noninvasive pain relief. Objective: This study aimed to assess the safety and efficacy of Litemed's pain management device (CURAPOD) in managing acute and chronic musculoskeletal pain at various pain sites, in comparison with a placebo, and to evaluate its efficacy across different skin types. Methods: In a double-blinded, randomized, placebo-controlled, multicentric study, 240 participants (aged 18-60 years) with acute or chronic musculoskeletal pain were enrolled and treated with either the test or control device for 30 minutes. The test device contains 7 LEDs designed to emit a combination of visible red and infrared radiation, while the control device emits visible light of the red spectrum. Pain intensity was subjectively measured at baseline, at 30 minutes after treatment, and at time windows of 8 to 12 hours and 21 to 24 hours after treatment. Results: A greater number of participants reported a reduction in pain (of up to 60%) in the treatment group than in the placebo group. Repeated measures ANOVA revealed significant effects of time (F3,684=282.37; P<.001) and treatment group (F1,228=662.12; P<.001), indicating that the relief experienced may be more sustained in the treatment group. No significant effects of pain site (F5,228=0.169; P=.97) or skin type (F5,228=0.8; P=.55) were observed, suggesting consistent action across anatomical locations and skin types. No significant adverse events were reported. Conclusions: The device appears to be safe and viable as a nonpharmacological adjunct for managing acute and chronic musculoskeletal pain. Treatment with the device showed short-term pain reduction, with reports of up to 60% pain reduction within 30 minutes of use and sustained self-reported relief in pain for up to 20 hours after treatment. No significant effects of pain sites or skin type on reduction in visual analog scale scores were observed, suggesting broad applicability. However, these results must be interpreted with caution while considering the limitations inherent to the study methodology and short-term follow-up. These findings should be interpreted as evidence of short-term analgesic response rather than definitive clinical effectiveness. Further investigation through rigorously designed randomized controlled trials and longitudinal studies is necessary to definitively establish the efficacy of the device, the durability of its action, and the potential integration of CURAPOD into pain management strategies.