JRCT ID: jRCTs032210354
Registered date:30/09/2021
Ultra-Ma study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Temporomandibular disorders of masticatory muscle pain |
Date of first enrollment | 13/10/2021 |
Target sample size | 24 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Subjects will be divided into two groups with different frequency of use of the test product. Group A will use a placebo at the start and an Active at the visit after 2weeks and 3 weeks. Group B will use the Active for 14 days after using the placebo at the start. |
Outcome(s)
Primary Outcome | Doctor's diagnosis (temporomandibular joint noise, palpation, opening amount) |
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Secondary Outcome | VAS |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 65age old |
Gender | Both |
Include criteria | 1.Adult men and women under 65 2.Japanese 3.Patients diagnosed with temporomandibular disorders and masticatory muscle pain disorders 4.Persons who have fully understood their participation in this research and obtained written consent at their own free will. |
Exclude criteria | 1. Subjects with diseases or disorders that require differentiation from temporomandibular disorders 2. Subjects who were taking anti-inflammatory analgesics, central muscle relaxants, antidepressants, or sleep-inducing drugs within 1 month from the time of the first visit 3. Subjects who received local treatment such as intramuscular injection into the muscles of mastication within 3 months from the first visit 4. Subjects who received occlusal therapy (sprint therapy, occlusal adjustment method), electrical stimulation therapy for the muscles of mastication, hyperthermia, massage, and other physical therapies within 3 months of the initial visit. 5. Subjects who have undergone surgical therapy (temporomandibular joint pumping therapy, temporomandibular joint endoscopic surgery, temporomandibular joint open surgery, cusp tendonectomy for masticatory muscle tendon / tendon membrane hyperplasia, etc.) 6. Subjects with complications such as musculoskeletal disorders that interfere with the performance of the test when participating in or conducting clinical research |
Related Information
Primary Sponsor | Naito Yosuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | Kamiyama Mfg.Co.,Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Takeshi Kaneko |
Address | 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo Tokyo Japan 160-0022 |
Telephone | +81-3-6302-0593 |
jacta@usjri.com | |
Affiliation | Japan Clinical Trial Association |
Scientific contact | |
Name | Yosuke Naito |
Address | 5F, 4-3-17 Shinjuku, Shinjuku-ku, Tokyo Tokyo Japan 160-0022 |
Telephone | +81-3-6302-0593 |
jacta@usjri.com | |
Affiliation | Japan Clinical Trial Association |