Usefulness of Bio-Power Generation Patches for Masticatory Muscle Pain Disorder of TMJ

JRCT ID: jRCTs032230628

Registered date:13/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: masticatory muscle pain disorder in patient with temporomandibular joint disorder
• Date of first enrollment: 13/02/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): The BioPower Patch will be applied to patients with TMJ masticatory muscle pain disorder, and its efficacy will be evaluated by comparing the change in pain-free maximum mouth opening before and 2 weeks after use of the BioPower Patch with that of the placebo patch. In addition, the safety of the BioPower Patch will be evaluated in terms of overall adverse events, mainly the frequency and rate of occurrence of facial skin disorders.

Outcome(s)

• Primary Outcome: Amount of change in painless maximum mouth opening

Secondary Outcome

The amount of change in the following items before and two weeks after the use of the bio-power patch
(1) Maximum self-actuated opening
(2) Forced maximum mouth opening
(3) VAS of masseter muscle tenderness on palpation
(4) VAS of masseter muscle pain during opening
(5) VAS of masseter muscle pain during mastication
(6) VAS for degree of daily life disturbance (psychosocial test)
(7) Change in the following items before and one week after the use of the BioPower Patch
(7) Maximum pain-free opening
(8) Maximum self-assisted opening
(9) VAS of daily life disturbance (psychosocial test)
(9) VAS of daily life disability (psychosocial test)
(10) Maximal pain-free opening
(11) Maximal self-assisted opening
(12) Forced maximum mouth opening
(13) VAS of tenderness on palpation of masseter muscle
(14) VAS of masseter muscle pain during opening
(15) VAS of masseter muscle pain during mastication
(16) VAS for degree of daily life disturbance (psychosocial test)
Other
(17) Usability of bio-generated patches
(18) Frequency and rate of occurrence of facial skin disorders

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

The following selection criteria will be applied to those who meet all of the following criteria.
(1) Those who have received a diagnosis of masticatory muscle pain of Temporomandibular joint disorders (Diagnostic Criteria for TMJ Disorders (2020))
(2) Persons who are able to manage and affix the device at home and fill out the recording form
(3) Age: Persons who are between 18 and 65 years old at the time of obtaining consent
(4) Gender: Any gender
(5) Those who have no difficulty in Japanese language proficiency for participation in the research..
(6) Persons who have received a full explanation of their participation in this research, and who have given their free and voluntary written consent based on a full understanding of the subject matter.
(7) Those who are able to make outpatient visits in accordance with the research schedule.

Exclude criteria

Patients who meet at least one of the following exclusion criteria will be excluded.
(1) Patients with intracranial diseases such as cerebro-medullary hypovolemia or musculoskeletal diseases such as muscular dystrophy, as well as diseases or disorders with open mouth disorder that require differentiation from temporomandibular joint disorder.
(2) Patients taking anti-inflammatory analgesics, central muscle relaxants, antidepressants, sleep inducing drugs, etc. within 1 month prior to obtaining consent
(3) Patients who have received intramuscular injection for mastication muscle pain within 1 month prior to obtaining consent
(4) Patients who have undergone physical therapy such as appliance therapy, occlusion therapy, electric stimulation therapy, heat therapy, and massage as basic treatment for TMJ arthrosis within one month prior to obtaining consent.
(5) Patients with a history of TMJ surgical treatment (TMJ pumping therapy, TMJ arthroscopic surgery, open TMJ surgery, masseter muscle tendonectomy, etc.) in the past.
(6) Patients with a history of alcoholism or drug addiction
(7) Patients with serious neurological or psychiatric diseases such as cerebrovascular disease, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, head injury with loss of consciousness, history of brain surgery with residual defect
(8) Persons using medical electrical devices implanted in the body that are susceptible to electromagnetic interference, such as pacemakers, implantable cardioverter-defibrillators, etc.
(9) Persons who have metal coils implanted intracranially
(10) Patients with serious or poorly controlled diseases at the time of consent, such as blindness, deafness, aphasia, etc.
(11) Patients who have participated in other clinical research or clinical trials within 3 months prior to obtaining consent
(12) Patients whose treatment for dental disease has not been completed
(13) Persons with a history of dermatitis caused by compresses or tapes
(14) Persons with bleeding, lacerations or abrasions, puncture wounds, injuries, inflammation, venous irritation or other abnormalities on the skin at the site of patch application
(15) Persons with a high fever 38 degrees or higher
(16) Others who are deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Hoshi Kazuto
• Secondary Sponsor: Kikkoman Corporation