EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain Relief
2026년 6월 16일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Leesburg, Florida, 미국, 34748
- The Dental Touch
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Ocala, Florida, 미국, 34471
- Chandra Wellness Center
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Kentucky
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Covington, Kentucky, 미국, 41011
- Applegate Dentistry & MedSpa
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Texas
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Frisco, Texas, 미국, 75034
- Stonebriar Smile Design
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Mandibular Range of Motion at 3 Months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 12월 8일
기본 완료 (추정된)
2026년 8월 1일
연구 완료 (추정된)
2026년 8월 1일
연구 등록 날짜
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
2026년 6월 16일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 16일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .