None listed
Conditions
Interventions
Drug : BoNT-A(Botulax®) was injected into the muscle showing tenderness to plapation using a 1-mL syringe with a 29-gauge, 0.5-inch needle
Two points in the masseter muscle, three in the temporal muscle, one in the splenius capitis, one in the sternocleidomastoid muscle, and one in the trapezius muscle were injected each with 10 U but no
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 years or older 2) Those who visited Yonsei University Dental Hospital and were diagnosed with masticatory muscle pain in temporomandibular disorder 3) Those who fully understand the contents of this study and voluntarily sign the consent form
Exclusion criteria
Exclusion criteria: 1) patients who received the injection of botulinum toxin within a year or myofascial trigger point injection, such as lidocaine, procaine, or bupivacaine, within a month based on screening 2) patients whose pain was caused by a disc or joint-related disease 3) Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis) 4) Patients who take certain medications like Aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxers, anticholinergic, benzodiazepines, benzamides, tetracyclines, lincomycins, etc.) within 4 weeks prior to screening visit 5) patients diagnosed with or treated for fibromyalgia 6) Known allergy or hypersensitivity to botulinum toxin preparation 7) Female who are pregnant, lactating, or likely to become pregnant, and who are not willing to use an acceptable form of contraception. 8) Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study 9) Participation in another interventional clinical study within the last 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in pain intensity in the orofacial area (assessed using the visual analog scale[VAS]) after 4, 8, and 12 weeks after injection compared to before injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in maximum mouth opening range(mm) after 4, 8, and 12 weeks after injection compared to before injection;Changes in headache intensity(assessed using the visual analog scale[VAS]) and headache frequency per month after 4, 8, and 12 weeks after injection compared to before injection;Changes in the number of tender points after 4, 8, and 12 weeks after injection compared to before injection | — |
Countries
Korea, Republic of
Contacts
Public ContactSora Kim
Yonsei University Health System, Dental Hospital
Outcome results
None listed