Effect of an Educational Intervention on Lower Limb Pain During the Hajj Mass Gathering: A Randomized Controlled Trial

Introduction/objectives: Lower limb pain is common and disabling from age 50 onwards, yet prevention before predictable episodes of intense ambulatory load has never been tested.We evaluated a pre-departure therapeutic patient education program in pilgrims attending a mass gathering.Method: A parallel-group randomized controlled trial (1:1) was conducted in two Moroccan vaccination centers: 218 pilgrims aged 50-75 years were enrolled in April 2025 and followed until late June 2025.The intervention group received a therapeutic patient education program, comprising a one-hour group education session plus an unsupervised home-based adapted physical activity program and WhatsApp reminders; controls received none.The primary outcome was lower limb pain on a visual analog scale (0-10) 48 hours after the end of the peak activity period.Analysis was by intention to treat, using linear mixed models, with blinded assessors and analyst.Results: The primary outcome was available for 216 of 218 participants (mean age: 62.6 years; 147 (67.4%) women).At T2 (48 hours after the end of the peak activity period), lower limb pain was lower in the education group (-1.75 points; 95% CI: -2.40 to -1.09; p<0.001); a smaller difference was already present seven days before departure, and the difference persisted seven days after return.The education group also had less limping (24 (22%) versus 42 (39.3%);p=0.01), less increased analgesic use (33 (30.3%) versus 48 (44.9%); p=0.027), less foot pain (11 (10.1%) versus 24 (22.4%);p=0.01), and better quality of life (+0.059;p=0.021).Low back pain, healthcare use, and falls did not differ.Conclusions: A pre-departure therapeutic patient education program, evaluated as a whole, produced a statistically significant reduction in lower limb pain in adults aged 50-75 years exposed to several days of intense walking.The point estimate did not reach the 2-point threshold set a priori, so a clinically important benefit can be neither confirmed nor excluded.Predictable episodes of high ambulatory load may offer a practical window for resource-light prevention, which requires confirmation against an active comparator.