رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT07153107 لـ Chronic TMD Pain، اضطراب المفصل الصدغي الفكي هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
جامعة منيسوتاR01_Pilot Jaw Muscle Phenotypes ١٠
R01_PilotStudy2_Jaw Muscle Metabolic and Brain-Derived Phenotypes of Chronic TMD Pain
- STUDY00025509
Local Heat Therapy
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطSelf-care with local heat therapy | Local Heat Therapy This will use a simple device provided to participants named "jaw bra", which is a head wrap with straps that goes around the chin and head that holds heated gel packs over the cheeks area |
بدون تدخلSelf-care without local heat therapy | غ/م |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Proportion of bad jaw pain fluctuations | Primary outcome includes the proportion of bad jaw pain fluctuations. A bad jaw pain fluctuation is defined as an increase ≥ 20 points from a previous measure. Jaw pain ratings will be collected daily for 8 days. The proportion of pain fluctuations is defined as the number of bad jaw pain fluctuations relative to the total number of jaw pain ratings. | 7 days following intervention |
Patient change in proportion of bad jaw pain fluctuations | Patient change in proportion of bad pain fluctuations will be assessed by comparing the proportion of bad jaw pain fluctuations between patients receiving heat therapy and matched patients not receiving heat therapy during the wait period. | 7 days following intervention |
Provide signed and dated informed consent form.
Willing to comply with all study procedures and be available for the duration of study participation.
Be 18 years or older.
Have a minimum set of teeth present, be it natural, implant-supported or fixed prosthodontics: all anterior teeth (incisors, canines), at least one premolar, at least one molar (first or second molar; third molars not considered).
TMD-Pain screener score equal to or greater than 3
Myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
Myofascial pain must meet the following criteria:
- Onset >3 months, occurring >15 days/month on average in the last three months from the screening session
- Minimum of 10 jaw pain episodes since onset, each episode lasting at least 30 minutes and no less than 2 hours within the day, OR unremitting
Traumatic facial injury or surgery on the face/jaw, arms or hands;
Presence of pain related to dental and periodontal pathology;
Currently undergoing active orthodontic treatment;
Pregnant;
Has any of the following medical conditions by self-report:
- Renal failure or dialysis,
- Heart disease (examples: uncontrolled arrythmia or hypertension, cardiomyopathy) or heart failure, Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema),
- Diabetes (type I or II) that is not controlled with medication or diet,
- Hyperthyroidism,
- Uncontrolled seizures;
Used any injection therapy (e.g., tender or trigger point injections, steroid injections), acupuncture, biofeedback, or TENS for the management of facial/jaw pain within 2 weeks prior to the screening assessment; If undergoing botulinum toxin injections in the head and neck area, must be 3 months since last set of injections and refrain from this treatment until study participation has ended
History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to the screening assessment;
History of treatment for drug or alcohol abuse within the last 12 months;
Current pain medication use (e.g., opioids, ibuprofen, acetaminophen) that cannot be stopped <24 hours prior to each study visit;
Current use of medically prescribed muscle relaxants for the duration of study participation;
Other conditions/diseases associated with altered pain perception: neurological or development disorders (dementia, autism spectrum disorder), neoplasm, multiple sclerosis, trigeminal neuralgia;
Adults lacking capacity to provide informed consent for themselves;
Unable to understand instructions for study procedures in English.
Anything that would place the individual at increased risk or preclude the individual's full compliance with study procedures or completion of the study."
جامعة منيسوتا403 تجارب سريرية نشطة للاستكشافMinnesota