رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06384898 (TAICHIKNEE) لـ الفصال العظمي في الركبة هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Remote Tai Chi for Knee Osteoarthritis (TAICHIKNEE)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06384898 (TAICHIKNEE) هي دراسة تدخُّلية لـالفصال العظمي في الركبة وهي قيد التجنيد. بدأت في ٩ شوال ١٤٤٦ هـ مع خطة لتجنيد ٤٨٠ مشاركًا. يقودها Tufts Medical Center، ومن المتوقع اكتمالها بحلول ١٠ ربيع الآخر ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٣ محرم ١٤٤٧ هـ.
الملخص
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:
- Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months?
- Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period?
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.
وصف مفصل
Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across four health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.
العنوان الرسمي
Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial
الحالات الطبية
الفصال العظمي في الركبةمعرّفات دراسة أخرى
- TAICHIKNEE
- STUDY00002259
- UH3AT012413 (منحة/عقد NIH الأمريكي)
NCT معرّف
تاريخ البدء (فعلي)
2025-04-07
آخر تحديث مُنشور
2025-07-08
تاريخ الاكتمال (المقدر)
2028-08-31
عدد المشاركين المخطط لهم
٤٨٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
Pragmatic Clinical Trial
Implementation Science
Mind-body Therapies
Tai Chi
Knee Osteoarthritis
Implementation Science
Mind-body Therapies
Tai Chi
Knee Osteoarthritis
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
تجريبيةTai Chi + Routine Care The intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation. | Remote Tai Chi Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements. |
بدون تدخلRoutine Care Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions). | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
WOMAC Pain Score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 3 months from randomization |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
PROMIS Pain Interference score | The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact. | 3 months from randomization |
SF-12 PCS score | The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health. | 3 months from randomization |
Number of knee joint injections | Total number of intra-articular injections identified through EHR and patient questionnaires. | 12 months from randomization |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
50 Years
الجنس المؤهل
الكل
- Age 50 years or older
- Treating clinician diagnosis of knee osteoarthritis
- Have a score of 40 (visual analog version) or greater on at least 1 of the 5 questions in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain) at baseline.
- Able to provide informed consent
- If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study
- If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks)
- Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention
- Is an active patient at one of the 4 participating healthcare system
- Currently practicing Tai Chi
- Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant's ability to participate in the Tai Chi safely, as determined by the principal investigators
- Unable to walk without a cane or other assistive device
- Any previous or scheduled knee replacement
- Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more.
- Reports suicidal ideations defined by a score on BDI-II item of 2 or 3 ('I would like to kill myself' or 'I would kill myself if I had the chance').
- Not English speaking
- Enrollment in any other clinical trial within the last 30 days
Tufts Medical Center- ⚕️Boston Medical Center
جامعة كاليفورنيا، لوس أنجلوس339 تجارب سريرية نشطة للاستكشاف- 🏥The Cleveland Clinic
- ⚕️National Center for Complementary and Integrative Health (NCCIH)
جهة اتصال مركزية للدراسة
جهة اتصال: Chenchen Wang, MD, MSc, 617-636-3251, [email protected]
جهة اتصال: Sherwood Alexis, MHA, MBA, 617-636-5405, [email protected]
1 مواقع الدراسة في 1 بلدان
Massachusetts
Tufts Medical Center, Boston, Massachusetts, 02111, United States
Sherwood Alexis, MHA, MBA, جهة اتصال, 617-636-5405, [email protected]
Chenchen Wang, MD, المحقق الرئيسي
William Harvey, MD, محقق فرعي
قيد التجنيد