Abstract / Summary
Background and objectiveNonpharmacological approaches for neuropathic pain are increasingly used, but noninvasive cutaneous stimulation devices remain insufficiently studied.The Tsubu-Tsubu Therapy Patch is an adhesive medical device containing glass beads and is suggested to provide analgesia through noninvasive stimulation based on the gate control theory.We conducted a prospective pilot clinical trial to explore its potential analgesic effect in patients with intractable neuropathic pain. MethodsA crossover trial aimed to enroll 26 patients.Patients were randomized to receive the treatment or control patches during Days 1-8 and Days 15-22, with a washout period on Days 9-14.The primary outcome was the between-treatment difference in daily Visual Analog Scale (VAS) scores, analyzed using a linear mixedeffects model.Secondary outcomes included mean VAS differences, PainVision scores, sleep duration, PainDETECT, Pain Disability Assessment Scale (PDAS), Athens Insomnia Scale (AIS), and adverse events. ResultsNine patients completed the study.Five had postherpetic neuralgia, and four had post-thoracotomy pain.The estimated treatment effect on daily VAS scores was -8.46 mm (95% CI, -11.83 to -5.09; p < 0.001).No significant effects of treatment period or day within the treatment period were observed.No statistically significant differences were observed in secondary outcomes, including mean VAS difference, sleep duration, pain-related measures (PainVision scores, PainDETECT, and PDAS), and AIS.Adverse events such as erythema, itching, and skin indentation occurred in both groups and were not serious. ConclusionsThis pilot trial found an estimated reduction in daily VAS scores with the Tsubu-Tsubu Therapy Patch compared with the control patch.Given the very small sample size and methodological limitations, these findings should be considered preliminary.Further adequately powered randomized controlled trials are needed to determine the clinical efficacy of this intervention.