Acupuncture for improving gait disturbance in Parkinson’s disease: A study protocol for a pilot randomized controlled trial

Abstract Introduction Parkinson’s disease (PD) is the progressive neurodegenerative disorder, characterized by bradykinesia, resting tremor, and muscle rigidity. Levodopa constitutes the preferred treatment for PD, but is limited by attenuated drug effect and dyskinesia. Therefore, alternative approaches may be useful to enhance levodopa treatment. Acupuncture may relieve PD symptoms, but there is little evidence to support its efficacy. We will assess whether acupuncture improves mobility, and will identify acupuncture-related changes in hemodynamic parameters and neurotransmitter levels, in PD patients with gait disturbance. Methods An assessor-blinded, randomized, controlled parallel trial will be conducted in 26 patients diagnosed with PD and gait disturbance. Patients will be randomly allocated to control (n = 13) or intervention groups (n = 13). Intervention will consist of acupuncture for 4 weeks and follow-up for 4 weeks. Control patients will not receive acupuncture and will be followed for 8 weeks. Conventional treatment will be allowed for both groups. Results Primary outcome measure is gait speed using GAITRite analysis. Secondary outcome measures are fNIRS-measured hemodynamic changes in motor and prefrontal cortices, along with neurotransmitter alterations, mobility parameters, and immediate, cumulative, and sustained effects of acupuncture. Discussion/Conclusions This trial will evaluate clinical effects of acupuncture in PD patients, and will confirm whether acupuncture alters neurotransmitter levels and associated activities. We expect improvement in gait parameters, changes in motor and prefrontal cortex activity, and changes in neurotransmitter activity, thereby providing insight into the therapeutic mechanism of acupuncture in PD and supporting further studies of whether acupuncture may improve motor symptoms in PD.