Analgesic effect of botulinum toxin on muscle pain in temporomandibular disorder patients : A randomized, double-blind, placebo-controlled pilot study
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008715
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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