Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial

Autor: Koh-Woon Kim, Yoon Jae Lee, Kyoung Sun Park, In-Hyuk Ha, Jongho Kim, Jae-Heung Cho
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Time Factors
Visual Analog Scale
Visual analogue scale
Cost-Benefit Analysis
Temporomandibular disorder
Acupuncture Therapy
Medicine (miscellaneous)
law.invention
Hominis placental pharmacopuncture
Study Protocol
03 medical and health sciences
0302 clinical medicine
Quality of life
Randomized controlled trial
law
Republic of Korea
medicine
Clinical endpoint
Protocol
Humans
Multicenter Studies as Topic
Placental Extracts
Pharmacology (medical)
030212 general & internal medicine
Adverse effect
Randomized Controlled Trials as Topic
Randomised controlled trial
lcsh:R5-920
Temporomandibular Joint
business.industry
Pharmacopuncture
Temporomandibular Joint Disorders
Temporomandibular joint
stomatognathic diseases
Treatment Outcome
medicine.anatomical_structure
Clinical research
Chronic Disease
Quality of Life
Physical therapy
Range of motion
business
lcsh:Medicine (General)
030217 neurology & neurosurgery
Zdroj: Trials, Vol 21, Iss 1, Pp 1-13 (2020)
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04442-8
Popis: Background Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Hominis placental pharmacopuncture (HPP), consisting of human placental extract, has been reported as effective for treating chronic musculoskeletal disorders, but a lack of well-designed randomised controlled trial s (RCTs) mean there is insufficient evidence to prove the efficacy of HPP. Methods This study is a two-arm parallel, assessor-blinded, multi-centre, randomised controlled trial. We will enrol 82 chronic TMD patients from rwo Korean Medicine hospitals in Axis 1, Group I according to RDC/TMD diagnostic criteria, and randomly allocate 41 patients each to an HPP group and a physical therapy (PT) group. Treatment will be administered in 10 rounds, after which there will be four follow-up visits 6, 9, 13, and 25 weeks from baseline. The primary end point is 6 weeks after baseline, and the primary outcome is the difference in Visual Analogue Scale (VAS) score for temporomandibular pain between baseline and week 6. Secondary outcomes will be Numeric Rating Scale (NRS) scores for temporomandibular pain and discomfort, temporomandibular joint range of motion, the Korean version of Beck’s Depression Index-II (K-BDI-II), Jaw Functional Limitation Scale (JFLS), Patient Global Impression of Change (PGIC) scores, and quality of life. Using data on adverse events and cost-effectiveness in the two groups, we will perform a safety assessment and a cost-effectiveness analysis (economic assessment). Discussion This study will assess the efficacy and safety of HPP for chronic TMD compared with PT. This RCT will provide evidence for the efficacy, safety, and economics of HPP. Trial registration clinicaTrials.gov (NCT04087005) / Clinical Research Information Service (CRIS) (KCT0004437) / IRB (JASENG 2017–09–002-002, KHNMCOH 2019–08-002) / Ministry of Food and Drug Safety (No. 31886).
Databáze: OpenAIRE
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