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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

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 wi...

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Autores principales: Jang, Jung-Hee, Kim, Jieun, Kwon, Ojin, Jung, So Young, Lee, Hye-Jin, Cho, Seung-Yeon, Park, Jung-Mi, Ko, Chang-Nam, Park, Seong-Uk, Kim, Hyungjun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9914000/
https://www.ncbi.nlm.nih.gov/pubmed/36767158
http://dx.doi.org/10.3390/ijerph20031776
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author Jang, Jung-Hee
Kim, Jieun
Kwon, Ojin
Jung, So Young
Lee, Hye-Jin
Cho, Seung-Yeon
Park, Jung-Mi
Ko, Chang-Nam
Park, Seong-Uk
Kim, Hyungjun
author_facet Jang, Jung-Hee
Kim, Jieun
Kwon, Ojin
Jung, So Young
Lee, Hye-Jin
Cho, Seung-Yeon
Park, Jung-Mi
Ko, Chang-Nam
Park, Seong-Uk
Kim, Hyungjun
author_sort Jang, Jung-Hee
collection PubMed
description 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.
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spelling pubmed-99140002023-02-11 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 Jang, Jung-Hee Kim, Jieun Kwon, Ojin Jung, So Young Lee, Hye-Jin Cho, Seung-Yeon Park, Jung-Mi Ko, Chang-Nam Park, Seong-Uk Kim, Hyungjun Int J Environ Res Public Health Study Protocol 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. MDPI 2023-01-18 /pmc/articles/PMC9914000/ /pubmed/36767158 http://dx.doi.org/10.3390/ijerph20031776 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Jang, Jung-Hee
Kim, Jieun
Kwon, Ojin
Jung, So Young
Lee, Hye-Jin
Cho, Seung-Yeon
Park, Jung-Mi
Ko, Chang-Nam
Park, Seong-Uk
Kim, Hyungjun
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9914000/
https://www.ncbi.nlm.nih.gov/pubmed/36767158
http://dx.doi.org/10.3390/ijerph20031776
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