ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07501676 (TUNES) के लिए Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), गर्भाशय फाइब्रॉइड्स, श्रोणि दर्द, दर्द प्रबंधन वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief (TUNES) 60
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07501676 (TUNES) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), गर्भाशय फाइब्रॉइड्स, श्रोणि दर्द, दर्द प्रबंधन से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 60 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 अप्रैल 2026 से शुरू होगा। Weill Medical College of Cornell University इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 सितंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 30 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This study will test whether gentle electrical stimulation to nerves near the uterus can reduce pelvic pain after uterine fibroid embolization. The investigators hypothesize that participants receiving active TUNES stimulation will experience lower pain levels and improved early recovery compared to those receiving sham stimulation or standard care.
विस्तृत विवरण
Pelvic pain after uterine fibroid embolization (UFE) is common and can slow recovery and increase the need for pain medication. There is growing interest in non-pharmacologic options that may help manage this discomfort. The TUNES device delivers gentle electrical stimulation through a vaginally placed disc, targeting sensory nerves involved in pelvic pain pathways. The components and stimulation levels fall within e...और दिखाएँ
आधिकारिक शीर्षक
Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
स्वास्थ्य स्थितियां
Postoperative Pain After Uterine Fibroid EmbolizationUterine Fibroids (UF)गर्भाशय फाइब्रॉइड्सश्रोणि दर्ददर्द प्रबंधनप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- TUNES
- 25-10029448
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-04-01
अंतिम अद्यतन प्रकाशित
2026-03-30
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-09-30
नामांकन (अनुमानित)
60
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
Transmucosal Uterosacral Electrical Stimulation
TUNES
Uterine Fibroid Embolization
UFE
Post-UFE Pain
Electrical Stimulation Therapy
Pelvic Pain Relief
Noninvasive Neuromodulation
Weill Cornell Medicine
TUNES
Uterine Fibroid Embolization
UFE
Post-UFE Pain
Electrical Stimulation Therapy
Pelvic Pain Relief
Noninvasive Neuromodulation
Weill Cornell Medicine
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकActive TUNES Device Participants will receive the active TUNES device, which delivers low-amplitude transvaginal electrical stimulation (0-10 mA, 80-120 Hz, 100-200 µs pulse width) using a modified menstrual disc with stainless-steel electrodes. Stimulation targets the uterosacral ligaments and associated nerve plexuses involved in pelvic pain. Sessions last 20 minutes each hour for up to 12 hours after uterine fibroid embolization (UFE...और दिखाएँ | TUNES (Transmucosal Uterosacral Electrical Stimulation) The TUNES device delivers low-amplitude transvaginal electrical stimulation (0-10 mA, 80-120 Hz, 100-200 µs pulse width) through stainless steel electrodes embedded in a modified menstrual disc. The device targets sensory nerves near the uterosacral ligaments and Frankenhauser plexus involved in pelvic pain signaling. It is powered by an FDA-cleared portable TENS unit (TENS 7000®). The stimulation is administered in ...और दिखाएँ |
दिखावटी उपचार तुलना समूहSham TUNES Device Participants will receive an identical TUNES device that appears and feels the same as the active version but delivers no electrical current. The device will be placed for the same duration and under the same conditions as the active arm to maintain blinding and control for placebo effects. | Sham TUNES Device A non-functioning version of the TUNES device that is identical in appearance, placement, and handling but delivers no electrical stimulation. It is used to maintain blinding and control for placebo effects. |
कोई हस्तक्षेप नहींStandard Care Control Participants will receive standard post-procedure care following uterine fibroid embolization, including access to patient-controlled analgesia (PCA) and non-opioid pain medications as clinically indicated. No TUNES device will be used in this arm. | निर्दिष्ट नहीं |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization | The mean number of patient-controlled analgesia (PCA) pump activations (button presses) within the first 12 hours after uterine fibroid embolization will be recorded. This measure reflects the frequency of patient-initiated pain medication use and serves as a quantitative indicator of post-procedural pain intensity. The mean number of activations will be compared across the active TUNES, sham TUNES, and control arms. | Up to 12 hours post-UFE |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Mean stimulation intensity over time during TUNES therapy | For participants in the active and sham TUNES arms, the average stimulation intensity (measured in mA) will be recorded hourly during the 0-12 hour period following UFE. This measure assesses tolerance, comfort, and consistency of device use throughout this post-UFE window. | 0 to 12 hours post-UFE |
Mean visual analog scale (VAS) pain score within 23 hours after uterine fibroid embolization | Pain intensity will be measured using a standard 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. VAS scores will be collected periodically during the first 23 hours post-UFE. The mean VAS score will be compared across the active TUNES, sham TUNES, and control arms to evaluate potential differences in perceived pain. | Up to 23 hours post-UFE |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क
अध्ययन के लिए न्यूनतम आयु
28 Years
अध्ययन के लिए पात्र लिंग
महिला
- Female, 28-52 years of age
- Scheduled to undergo uterine fibroid embolization (UFE) at Weill Cornell Medicine
- Able to provide informed consent
- Willing to comply with all study procedures and follow-up
- Fluent in English (for completion of study assessments)
- Known or suspected pregnancy
- Active pelvic infection
- History of pelvic inflammatory disease within the past 6 months
- Implanted electrical device (e.g., pacemaker, neurostimulator)
- Current use of opioid pain medication prior to procedure
- History of chronic pelvic pain not related to fibroids
- Known allergy or sensitivity to medical-grade silicone
- Participation in another interventional study within 30 days
Weill Medical College of Cornell Universityअध्ययन केंद्रीय संपर्क
संपर्क: Maurice Hurd, M.A., 646-962-8690, [email protected]
संपर्क: Marc Schiffman, M.D., 646-962-9185, [email protected]
1 1 देशों में अध्ययन स्थान
New York
Weill Cornell Medicine, New York, New York, 10022, United States
Marc Schiffman, M.D., संपर्क, 646-962-9185, [email protected]
Maurice Hurd, M.A., संपर्क, [email protected]
Marc Schiffman, M.D., मुख्य अन्वेषक