NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032210354

Registered date:30/09/2021

Ultra-Ma study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedTemporomandibular disorders of masticatory muscle pain
Date of first enrollment13/10/2021
Target sample size24
Countries of recruitment
Study typeInterventional
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 OutcomeDoctor's diagnosis (temporomandibular joint noise, palpation, opening amount)
Secondary OutcomeVAS

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 65age old
GenderBoth
Include criteria1.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 criteria1. 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

Contact

Public contact
Name Takeshi Kaneko
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo Tokyo Japan 160-0022
Telephone +81-3-6302-0593
E-mail 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
E-mail jacta@usjri.com
Affiliation Japan Clinical Trial Association