ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07165392 के लिए न्यूरोमॉड्यूलेशन, ऊपरी अंग, मस्कुलोस्केलेटल विकार 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
Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Upper Limb: a Double-blind Randomized Clinical Trial
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT07165392 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो न्यूरोमॉड्यूलेशन, ऊपरी अंग, मस्कुलोस्केलेटल विकार से जुड़ा हुआ है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 120 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 अक्तूबर 2025 से शुरू होगा। University of Malaga इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 मार्च 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 10 सितंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the upper limb, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the muscles and joints of the lower limb, stretching of the involved muscles, and neuromodulation of the brachial plexus nerve root, which innervates the affected structures. The third and fourth intervention groups will receive the same treatment as mentioned above, but without neuromodulation. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure range of motion and muscle strength. Subjective variables will also be used through validated questionnaires, covering physical activity, health-related quality of life, upper limb function, and a visual analog scale for pain perception.
आधिकारिक शीर्षक
Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Upper Limb: a Double-blind Randomized Clinical Trial
चिकित्सीय स्थितियाँ
न्यूरोमॉड्यूलेशनऊपरी अंगमस्कुलोस्केलेटल विकारअन्य अध्ययन आईडी
- 152/2025
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-10-01
अंतिम अद्यतन प्रकाशित
2025-09-10
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-03-31
नामांकन (अनुमानित)
120
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकNeuromodulation 2 times per week | न्यूरोमॉड्यूलेशन The application of neuromodulation therapy will be carried out with the support of ultrasound visualization on the anatomical area of the target nerve, seeking a motor and/or sensory response with its stimulation. शारीरिक व्यायाम The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms. स्ट्रेचिंग To stretch the muscles involved, 3 periods of maximum tolerable stretching without pain will be performed, lasting 20 seconds and resting for 30 seconds. |
प्रयोगात्मकNeuromodulation 3 times per week | न्यूरोमॉड्यूलेशन The application of neuromodulation therapy will be carried out with the support of ultrasound visualization on the anatomical area of the target nerve, seeking a motor and/or sensory response with its stimulation. शारीरिक व्यायाम The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms. स्ट्रेचिंग To stretch the muscles involved, 3 periods of maximum tolerable stretching without pain will be performed, lasting 20 seconds and resting for 30 seconds. |
प्रयोगात्मकNon-neuromodulation 2 times per week | शारीरिक व्यायाम The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms. स्ट्रेचिंग To stretch the muscles involved, 3 periods of maximum tolerable stretching without pain will be performed, lasting 20 seconds and resting for 30 seconds. |
प्रयोगात्मकNon-neuromodulation 3 times per week | शारीरिक व्यायाम The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms. स्ट्रेचिंग To stretch the muscles involved, 3 periods of maximum tolerable stretching without pain will be performed, lasting 20 seconds and resting for 30 seconds. |
प्राथमिक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
EUROQOL-5D (EQ-5D) | It consists of a generic instrument for measuring health-related quality of life (HRQoL), which consists of two parts: a descriptive system for assessing health status (ranging from 1, meaning "I have no problems" to 3, "many problems") and a visual analogue scale (ranging from 0, which is the worst imaginable health status, to 100, which is the best imaginable health status). | Baseline and up to one year |
SHORT FORM 12 HEALTH SURVEY (SF-12) | The SF-12 questionnaire is composed of a subset of 12 items derived from the SF-36, with the physical and mental components being scored as the only items. Depending on the item, response options range from 3 to 6, with each question receiving a value that is subsequently transformed into a scale of 0 to 100. All scores have a mean of 50, with values above or below 50 indicating better or worse health status, respectively, compared to the reference population. | Baseline and up to one year |
DISABILITIES OF ARM, SHOULDER AND HAND (DASH) | It consists of a self-administered questionnaire that assesses the upper limb as a functional unit and allows for the quantification and comparison of the impact of the different processes affecting different regions of the limb. It consists of a core of 30 items and two optional modules with four items each. Each item is scored from 1 to 5, with higher scores corresponding to greater symptom intensity. The final score can range from 30 to 150 points, with a scale of 0 (best possible score) to 100 (worst possible score). The optional modules are scored separately. | Baseline and up to one year |
UPPER LIMB FUNCTIONAL INDEX (ULFI) | This is a 25-item questionnaire that measures upper limb function. Patients are asked to answer YES if they can perform the action (1 point) and NO if they cannot perform it (0 points). There is also a HALF option (partially perform it), which is worth 0.5 points. The score is then obtained by summing the responses and is finally converted into a 100-point percentage scale. | Baseline and up to one year |
International Physical Activity Questionnaire (IPAQ) | An instrument designed to measure physical activity levels in an adult population and serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous activity) to 4 (sedentary). | Baseline and up to one year |
Visual Analogue Scale (VAS) | It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability. | Baseline and up to one year |
RANGE OF MOTION | Range of motion refers to the number of degrees through which a joint is capable of moving. To measure the elbow's flexion-extension range, the flexion and extension movements are recorded with the arms at the sides and the elbows fully extended. For the forearm, supination and pronation movements are measured with the arm relaxed. For the shoulder, the degrees of flexion, extension, abduction, adduction, and internal and external rotation are measured with the patient in a seated position. Finally, to measure flexion, extension, and radial and ulnar deviations at the wrist, the hand is placed on a flat surface. Measurements are taken with an electronic goniometer, and the patient will be asked to cooperate in determining the pain limit. | Baseline and up to one year |
MUSCULAR STRENGTH | Isometric muscle strength will be assessed using a dynamometer. | Baseline and up to one year |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Participants in the study will be men and women of working age, diagnosed with musculoskeletal disorders of the upper limb, and who have not yet received physical therapy.
- Have undergone surgery.
- Those who refuse to participate in this study.
- Patients who present muscular atrophy in the upper limb due to a pathology of the latter.
- Medical conditions that are contraindications for neuromodulation therapy
University of Malagaअध्ययन उत्तरदायी पक्ष
Dr. Manuel González-Sánchez, मुख्य अन्वेषक, Principal Investigator, University of Malaga
कोई संपर्क डेटा नहीं।