Efficacy of High-Intensity Laser Therapy Combined With Plantar Fascia Stretching Exercises in the Treatment of Plantar Fasciitis: Randomized, Double-Blind, Sham-Controlled Trial.

Background: Plantar fasciitis causes heel pain and functional limitations; conservative treatment typically includes plantar fascia and calf stretching. High-intensity laser therapy (HILT) offers deeper photobiomodulation and potential tissue-healing benefits, but robust evidence of added clinical benefit remains limited. Objective: This study aims to evaluate the efficacy of HILT combined with plantar fascia stretching exercises compared with a sham control for the treatment of plantar fasciitis. Methods: This study was designed as a randomized, double-blind, sham-controlled trial conducted at the outpatient clinic of a university hospital. Participants were randomly allocated into 2 groups: the HILT group and the sham treatment group. Both groups received 9 treatment sessions over 3 weeks. The HILT group received active laser therapy, while the sham group received identical treatment without laser emission. The HILT used a wavelength of 1064 nm in continuous mode, with a power output of 12 W applied for 250 seconds, delivering an energy density of 120 J/cm² applied to a 25-cm² area for a total energy of 3000 J. In addition to the assigned interventions, all participants performed a standardized self-stretching exercise program targeting the plantar fascia and Achilles tendon throughout the study period. The primary outcome was pain intensity measured using a visual analog scale. Secondary outcomes included ultrasonographic measurement of plantar fascia thickness (PFT) and the subjective foot and ankle ability measure (FAAM) score, recorded before and immediately after the intervention. Results: A total of 34 patients diagnosed with unilateral plantar fasciitis were enrolled in this study. Based on intragroup comparison, both groups demonstrated statistically significant improvements in all outcomes compared with baseline (P<.001). However, no significant differences were found between the 2 groups across all outcomes. The mean difference in pain reduction, measured by the visual analog scale, was -35.3 (95% CI -45.3 to -25.0) mm in the HILT group and -30.4 (95% CI -46.3 to -14.4) mm in the sham group (-5.0 mm, 95% CI -14.3 to 4.3; P=.59). Similarly, reductions in PFT and improvements in FAAM scores showed no significant differences between groups (mean difference -0.02 mm, 95% CI -0.2 to 0.1; P=.90 and 5.6 points, 95% CI -1.1 to 12.4; P=.40, respectively). Conclusions: There was no additional clinical effectiveness of HILT on pain reduction, decreased PFT, or increased FAAM scores compared with sham laser when combined with standard stretching exercises for plantar fasciitis and the Achilles tendon.