Abstract
Background: Filiform-fire-needle(FFN)has been used in clinical treatment of upper extremity spastic paralysis after stroke(UESPAS). This study will evaluate the effect of filiform-fire-needle in the treatment of UESPAS under the background of standardized clinical research, and study the relationship between the efficacy and the course of treatment, so as to provide high-quality evidence-based basis for further clinical treatment and future research design.Methods: A prospective randomized controlled study was conducted to evaluate the clinical efficacy of FFN acupuncture therapy for patients with UESPAS. UESPAS patients were recruited in Changhai Hospital, Shanghai, China and they were randomly divided into FFN acupuncture group (F group), filiform needle acupuncture group (A group) or rehabilitation treatment group (R group). During the 20-day treatment, the same acupoints were taken in A group and F group. F group was treated once every 2 days for a total of 10 times, while A group and R group were treated 8 d in a row and then rest for for 2 days for a total of 16 times. In this study, the primary outcome indicators were modified Ashworth scale (MAS), secondary results including Fugl-Meyer assessment of Upper Extremity Motor Function (FMA-UE), National Institutes of Health Stroke Scale (NIHSS), Barthel index (BI). The above scales were evaluated before treatment, 10 days and 20 days after treatment. The safety was evaluated by self-made acupuncture adverse reaction observation table.Results: A significant difference was observed in MAS, FMA-UE, BI, NIHSS in the three groups from pre- to post treatment. From the evaluation of the changes of MAS, the curative effect of F group was better than the other two groups after 10 days of treatment, and F group was better than the R group on the 20th day, but there was no significant difference among the three groups after follow-up. The the difference of FMA-UE score showed F group was higher than the other two groups after 20 days of treatment and follow-up. The change of BI score in group F was higher than that in group R after 10 days of treatment, and the change of BI score in group F was higher than that in the other two groups after 20 days of treatment and follow-up. No significant change in the score of NIHSS was found in three groups.Conclusions: FFN acupuncture therapy has an advantage in relieving upper limb spasm and improving the activities of daily life of stroke patients in the short term, and in the long term, FFN has advantages in improving the motor ability of spastic limbs and improving the ability of daily life of patients.