Effects of acupuncture on sensory symptoms and motor signs in patients with restless legs syndrome: A crossover randomized controlled trial

Rapid effects of acupoint injection (acuinjection) at 4 acupoints (4P) (ST36, GB41, SP6, and BL60) on legs presenting sensory symptoms and motor signs in restless legs syndrome (RLS) were first described in a case report. This study aimed to confirm the beneficial effects of acuinjection. METHODS: A randomized, controlled, single-blinded, prospective crossover study was conducted during 2018 to 2021. Adult volunteers (age ≥ 20 years) with RLS symptoms for > 2 weeks were included. Eight adults were enrolled and randomized to receive acuinjection (Verum group) or sham injection (Sham group). The effects of acuinjection on discomfort and periodic leg movement (PLM) were evaluated using the suggested immobilization test in a crossover design. The acupoint used was 4P, and normal saline solution (0.1–0.25 mL) was injected in both groups. Leg discomfort was measured using the visual analog scale (VAS), and PLM was measured using an electromyogram. To compare the VAS scores between the groups, repeated measures analysis of variance was used, and the Student t test was used to assess the mean discomfort score (MLDS: average of the 6 VAS scores) and PLM index (PLMI) (defined as the degree of PLM/hour). RESULTS: A significant difference in the VAS score was observed; however, no significant difference was noted in the PLMI between the groups. The MLDS was significantly lower in the Verum group than in the Sham group. CONCLUSION: Acuinjection at 4P remarkably inhibited leg discomfort in patients with RLS. Despite the drastic PLM suppression in 1 patient by acuinjection, a statistically significant inhibition of PLM was not confirmed. The results of our study can be applied easily and safely in clinical situations where it is necessary to temporarily reduce or eliminate RLS symptoms.