Effectiveness and Therapeutic Mechanism of Pharmacopuncture for Pain in Parkinson’s Disease: A Study Protocol for a Pilot Pragmatic Randomized, Assessor-Blinded, Usual Care-Controlled, Three-Arm Parallel Trial

Abstract

Pain in Parkinson’s disease (PD) represents a complex phenotype known to decrease quality of life. This pragmatic randomized, controlled clinical trial evaluated the efficacy of pharmacopuncture (PA) for improving pain symptoms and investigated the corresponding therapeutic mechanisms in patients with PD. Ninety patients with PD-related pain were randomly allocated to receive either PA, manual acupuncture, or usual care in a 1:1:1 ratio; sixty healthy controls were included for comparative analysis of brain imaging data. Over 12 weeks, study treatment provided 2 days per week for 8 weeks with a follow-up period of 4 weeks. The primary outcome measure was the King’s Parkinson’s Disease Pain Scale score for assessing improvement in PD-related pain, including a sub-analysis to investigate the pattern of changes in pain according to a PD-related pain mechanism-based classification. Secondary outcome measures included a numerical rating scale-based assessment of the intensity and location of pain and changes in pain-associated symptoms, such as depression, anxiety, and sleep disorders. Exploratory outcome measures included structural and functional brain patterns on magnetic resonance imaging, blood molecular signature changes, gait analysis, facial expression and movement assessment in response to emotional stimuli, and a traditional Korean medicine syndrome differentiation questionnaire. The trial findings provided important clinical evidence for the effectiveness of PA in the management of PD-related pain and its associated symptoms, and helped elucidate the mechanism of its therapeutic effect on PD-related pain.

Use of Herbal Decoction and Pharmacopuncture in Individuals with Chronic Disease: findings from a nationally representative panel

“…Research on PA focuses on musculoskeletal diseases and obesity [ 24 ]. However, clinical trials of PA for non-musculoskeletal diseases, such as Parkinson’s disease [ 25 ] and insomnia [ 26 ], are underway in South Korea. According to a survey of KM doctors, PA is used for musculoskeletal diseases and for neurological and gastrointestinal diseases [ 27 ].…”

Clinical observation and mechanism of acupuncture on amnestic mild cognitive impairment based on the gut-brain axis: study protocol for a randomized controlled trial

“…Recently, increasing number of randomized clinical trial (36,60,61) have recruited healthy volunteers and determined the pathological features in the population of patients by comparing them with patients. Patients with MCI were reported to have altered levels of peripheral and cerebrospinal fluid inflammatory markers, abnormal cognitive-related brain network function, and distinct gut microbiota composition compared with healthy controls (62)(63)(64).…”