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ObjectivesEffectiveness of Foot Reflexology (FR) on the pain intensity in Parkinson's disease (PD) compared with Sham Massage (SM).DesignMonocentric, longitudinal, prospective, double-blind, randomized controlled trial. Randomization with a random number generator in the R software. Fixed-sized block randomization of 3 implemented into Clinsight.ParticipantsIdiopathic PD patients with chronic pain (Visual Analogue Scale (VAS)≥4) were recruited from the Toulouse University Hospital between the 14th of April 2021 and the 25th of May 2025.InterventionFour one-hour long FR or SM sessions three weeks apart with the same specialized FR researcher.Main outcome measurePain intensity change measured by the mean VAS before and after full completed interventions. The difference was compared between group using a Wilcoxon Mann Witney test. Exploratory outcome: brain functional connectivity.Results30 PD patients were randomized and analyzed. Interventions were delivered as planned for all patients. Clinical variables did not significantly differed between FR and SM groups. Mean VAS decreased by -12.3 mm ± 15.2 in FR group (n = 15) and -17.9 mm ± 29.4 in SM group (n = 15). Analyses did not reveal any significant difference between the FR and SM groups (p-value = 0.88). There are different patterns in connectivity changes in the medial pain system between responders (at least 30% pain reduction) and non-responders to both therapies. There were no adverse events.ConclusionFR is not more effective than SM in relieving chronic pain in PD. The differences in connectivity patterns within the medial pain pathway may underlie the response to tactile stimulation (FR and SM).Trial registrationClinicalTrials.gov NCT04705207.
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