EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief
2026年6月16日 更新者：BTL Industries Ltd.
Evaluating the Safety and Efficacy of the BTL-043 and BTL-785F Devices in Alleviating Temporomandibular Joint (TMJ) Pain
This prospective, multi-center, open-label, single-arm clinical study will evaluate the efficacy and performance of the BTL-043 and BTL-785F devices for alleviating TMJ pain.
Up to 60 subjects will undergo four treatment visits, administered 2-10 days apart, followed by 1-month and 3-month follow-up visits.
During a single treatment session at each visit, subjects will receive consecutive treatment with both devices.
At baseline, informed consent, eligibility assessment, Fitzpatrick phototype evaluation, TMD Disability Index, VAS, weight and height measurements, 2D mandibular ROM photographs, and mandibular/lateral ROM assessments will be completed.
A urine pregnancy test will be performed prior to each treatment visit.
After the final treatment, subjects will complete the TCQ, SSQ & QoL, TMD Disability Index, and VAS, and repeat all physical assessments.
At both follow-up visits, subjects will complete the SSQ & QoL, TMD Disability Index, and VAS, and repeat the physical assessments.
Safety will be evaluated through documentation and assessment of adverse events at each treatment and follow-up visit.
調査の概要
研究の種類
介入
入学 (実際)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Leesburg、Florida、アメリカ、34748
- The Dental Touch
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Ocala、Florida、アメリカ、34471
- Chandra Wellness Center
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Kentucky
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Covington、Kentucky、アメリカ、41011
- Applegate Dentistry & MedSpa
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Texas
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Frisco、Texas、アメリカ、75034
- Stonebriar Smile Design
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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 significant change during study participation
- Subject is 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, nursing, or IVF procedure
- 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
- Subjects currently undergoing, or who have received, radiation therapy or chemotherapy within the past 6 months prior to study treatment
- Known or suspected malignancy, history of cancer, any type of malignancy or pre-malignant moles
- Febrile conditions, serious illness, chronic infection
- Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- Sensory or sensitivity disorders in the treatment area
- Active bacterial or viral infection, acute inflammation
- Impaired immune system
- Isotretinoin in the past 12 months
- Skin-related autoimmune diseases
- Poor healing and unhealed wounds in the treatment area
- Metal implants near the treatment area or neutral electrode
- Permanent implant near the treatment area
- Pacemaker or internal defibrillator, or any other active electrical implant, anywhere in the body
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
- Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
- Any surgical procedure in the treatment area within the last three months or before complete healing
- Tuberculosis
- Hepatitis
- Poorly controlled endocrine disorders
- History of bleeding coagulopathies
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Skin dermabrasion, skin resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- Electroanalgesia without exact diagnose of pain etiology
- Serious psychopathological disorders (such as schizophrenia)
- Inflammation of blood or lymphatic vessels
- Scarring in the treatment area
- Swollen, infected, or inflamed areas or damaged skin, skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
- Hypersensitive carotid sinus
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Treatment with BTL-043 and BTL-785F device
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All subjects will receive a consecutive treatment with the BTL-043 and BTL-785F devices during a single visit.
Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits conducted at 1 month and 3 months after the last treatment.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
時間枠：Baseline and 3 months
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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.
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Baseline and 3 months
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Change from Baseline in the Temporomandibular Dysfunction (TMD) Disability Index Score at 3 Months
時間枠：Baseline and 3 months
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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.
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Baseline and 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Mandibular Range of Motion at 3 Months
時間枠：Baseline and 3 months
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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.
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Baseline and 3 months
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Incidence of Treatment-related Adverse Events
時間枠：From baseline up to 3 months post-treatment
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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
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From baseline up to 3 months post-treatment
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Change from Baseline in Lateral Range of Motion at 3 Months
時間枠：Baseline and 3 months
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Lateral mandibular range of motion is measured objectively in millimeters (mm) using a specialized scale.
Two measurements are taken: left lateral excursion (moving the lower jaw as far as possible to the left) and right lateral excursion (moving the lower jaw as far as possible to the right).
A positive change from baseline (an increase in the measured mm) indicates an improvement in lateral jaw mobility.
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Baseline and 3 months
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Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
時間枠：3 months post treatment
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Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 17-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.
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3 months post treatment
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Therapy Comfort Assessed by the Therapy Comfort Questionnaire
時間枠：Immediately after the final treatment
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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.
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Immediately after the final treatment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年12月8日
一次修了 (推定)
2026年8月1日
研究の完了 (推定)
2026年8月1日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。