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

Jung-Hee Jang, Jieun Kim, Ojin Kwon, So Young Jung, Hye-Jin Lee, Seung-Yeon Cho, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park () and Hyungjun Kim ()
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Jung-Hee Jang: Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
Jieun Kim: Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
Ojin Kwon: Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
So Young Jung: Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea
Hye-Jin Lee: Department of Korean Medicine Cardiology and Neurology, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea
Seung-Yeon Cho: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
Jung-Mi Park: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
Chang-Nam Ko: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
Seong-Uk Park: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea
Hyungjun Kim: Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea

IJERPH, 2023, vol. 20, issue 3, 1-12

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.

Keywords: acupuncture therapy; Parkinson’s disease; nociceptive pain; neuroimaging (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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