BACKGROUND: Few studies have investigated the dry needling (DN) approach on knee osteoarthritis (KO) patients. The study's aim was to evaluate the short-term efficacy of adding DN to a therapeutic exercise protocol in the treatment of KO in older adults. METHODS: A double-blind, pilot clinical trial with parallel groups (NCT02698072) was carried out for 12 weeks of treatment and follow-up. Twenty patients aged 65 years and older with myofascial trigger points (MTrPs) in the muscles of the thigh were recruited from older-adult care centers and randomly assigned to a DN+exercise group or a sham-DN+exercise group. The numeric rating scale (NRS; primary outcome) and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire (WOMAC) were assessed before and after the intervention. RESULTS: The NRS (analysis of variance, ANOVA) showed statistically significant differences in the time factor (F = 53.038; p < 0.0001; eta-p2 = 0.747). However, it did not show a significant change in the group-time interaction (F = 0.082; p = 0.777; eta-p2 = 0.005). The WOMAC scores (ANOVA) showed statistically significant differences in the time factor for total score WOMAC questionnaire (F = 84.826; p < 0.0001; eta-p2 = 0.825), WOMAC pain (F = 90.478; p < 0.0001; eta-p2 = 0.834), WOMAC stiffness (F = 14.556; p < 0.001; eta-p2 = 0.447), and WOMAC function (F = 70.872; p < 0.0001; eta-p2 = 0.797). However, it did not show a statistically significant change in the group-time interaction. CONCLUSION: Despite the pain intensity and disability clinically relevant improvement for both DN and sham-DN combined with exercise, 6 sessions of DN added to a therapeutic exercise program for older adults with KO did not seem to improve pain intensity and functionality.

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