Abstract
BackgroundTemporomandibular 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.MethodsThis 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).DiscussionThis 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 registrationclinicaTrials.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).
Highlights
Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures
We aim to evaluate the efficacy, safety, and economics of Hominis placental pharmacopuncture (HPP) for chronic TMD
HPP is used for various musculoskeletal disorders in South Korea, including TMD, there is currently a lack of evidence regarding its efficacy for TMD
Summary
Temporomandibular disorder (TMD) is a condition encompassing clinical symptoms of the temporomandibular joint, masseter muscle, and surrounding structures. Temporomandibular disorder (TMD) encompasses clinical symptoms of the temporomandibular joint (TMJ), masseter muscle, and surrounding structures. The most common symptoms of TMD are pain in the TMJ and masseter muscle, asymmetry, and restricted motion of the TMJ, and crepitus of the TMJ; these symptoms may be accompanied by ear pain, tinnitus, dizziness, neck pain, and headaches. Symptom onset can be mild or acute and, like patients with chronic pain in other areas, continuous pain in the TMJ is often accompanied by physical, behavioural, and psychological symptoms [1]. RDC/ TMD is a multidimensional assessment that divides TMD into muscle and joint problems (Axis 1) and psychological problems (Axis 2) via a process of diagnosis and testing for symptoms including mouth opening, range of motion (ROM), pain, and discomfort. In Axis 1, TMD is classified into group I (myofascial pain), II (disc displacements) or III (other joint conditions), while Axis 2 examines the extent of pain, and the presence and extent of accompanying neuropsychological symptoms
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