Facial Pain, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
Conditions
Brief summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the investigational BTL-043 device in alleviating Temporomandibular Joint (TMJ) pain in adults aged 22 years and older. The main questions it aims to answer are: Does the BTL-043 device effectively reduce TMJ pain? Does the treatment improve jaw mobility (mandibular range of motion) and reduce the impact of TMJ disorders on daily activities? Is the treatment comfortable and safe for participants? Participants will: Receive four 20-minute treatments with the BTL-043 laser, spaced 2 to 10 days apart. Attend follow-up clinic visits 1 month and 3 months after their final treatment. Complete questionnaires about their pain levels (Visual Analogue Scale), daily activities (TMD Disability Index), and treatment comfort and satisfaction. Have their jaw mobility (mandibular range of motion) measured
Interventions
DEVICETreatment with BTL-043
Four (4) treatment sessions will be applied to the subjects' temporomandibular joint (TMJ) area using the BTL-043 system (a Class IV laser operating at a 1064 nm wavelength). Each treatment session lasts 20 minutes and is spaced 2 to 10 days apart.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults seeking alleviation of pain in the treatment area * Age 22 years and older * Voluntarily signed an informed consent form * Subject is willing to comply with study instructions, to return to the clinic for the required visits * Willingness to adhere to and continue current pain management plan * Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change during study participation * Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat TMJ pain * Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study \*Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
Exclusion criteria
* Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus * Current pregnancy * Photosensitivity, medications affecting sensitivity to light * Tattoos or other higher pigmented regions in the treated area * Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use * Anticoagulant therapy, bleeding disorders * Hemorrhage in the treated area * Application over the thyroid or other endocrine glands * Application within 4 to 6 months after radiotherapy * Known or suspected malignancy, history of cancer or any type of malignancy * Febrile conditions, serious illness, chronic infection * Epilepsy * Sensory loss in the treatment area * Deep vein thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months | Baseline and 3 months | The Visual Analogue Scale (VAS) is a self-reported measure used to assess the intensity of TMJ-related pain experienced by the participants in the treatment area. Participants rate their perceived pain level on a numerical scale ranging from 0 to 10. On this scale, 0 is equivalent to "no pain" and 10 indicates the "worst possible pain". The baseline score is compared to the score collected at the 3-month follow-up visit. A negative change from baseline (a decrease in the VAS score) indicates a reduction in pain intensity and an improvement in the participant's condition over time. |
| Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months | Baseline and 3 months | The Temporomandibular Dysfunction (TMD) Disability Index is a self-reported questionnaire used to assess the impact of TMJ disorders on a participant's daily activities, such as talking, chewing, and sleeping. The questionnaire consists of 10 categories, each containing 5 statements. Each category is scored on a scale from 0 to 4, where 0 represents no limitation and 4 represents maximum restriction due to pain. The overall score is calculated by summing the scores of all 10 items, resulting in a total possible score ranging from 0 to 40. On this scale, a total score of 0 indicates no disability and 40 indicates extreme disability. A negative change from baseline (a decrease in the total score) indicates a reduction in disability and an improvement in the participant's condition over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Mandibular Range of Motion at 3 Months | Baseline and 3 months | Mandibular range of motion is measured objectively in millimeters (mm) using a specialized scale. Two measurements are taken: "comfort" (opening the mouth to a comfortable level without pain) and "active" (opening the mouth as wide as possible despite the presence of pain). A positive change from baseline (an increase in the measured mm) indicates an improvement in jaw mobility. |
| Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire | 3 months post treatment | Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 13-item self-reported questionnaire. Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree". Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life. |
| Therapy Comfort Assessed by the Therapy Comfort Questionnaire | Immediately after the final (fourth) treatment | Therapy comfort is assessed using a self-reported questionnaire. Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable"). Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Lower pain scores and higher agreement scores indicate greater therapy comfort. |
| Incidence of Treatment-related Adverse Events | From baseline up to 3 months post-treatment | Overall safety is evaluated continuously by monitoring, assessing, and recording the occurrence and severity of any adverse events, side effects, or unanticipated problems throughout the course of the study |
Countries
United States
Outcome results
None listed