Wrist Denervation Vs Exercise in Wrist Osteoarthritis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Self-managed exercise therapy program, Partial wrist denervation.
- Кому может быть актуально
- Состояния в реестре: Osteoarthritis Wrist. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients with Wrist Osteoarthritis: a Randomized Controlled Multicenter Trial
Обзор
A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.
Подробное описание
Backgroud:
High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.
Aim:
To analyze:
1. Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA? 2. Is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion?
Method:
A multicenter parallel group, two-arm, randomized, controlled, assessor blinded, trial of 140 patients. The study is conducted at the departments of hand surgery at Södersjukhuset Stockholm and Malmö University hospital.
Group1:
Self-managed exercise therapy program containing:
* Patient education: * Exercise therapy program:
The exercise therapy program is designed by Sara Larsson (physiotherapist at the Department of hand surgery in Malmö, Sweden), influenced by previous studies on wrist stability and proprioception. Focus is on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. The program consists of neuromuscular exercises that focus on coordination, wrist stability and strength.
Group 2:
Surgery will be performed under local anesthesia (+ blood-less field or wide-awake local anesthesia no torniquet (WALANT) according to the surgeon's preference) through a single dorsal incision. AIN and PIN neurectomy will be performed as described by Berger (Berger, 1998).
Primary outcome:
Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998) 12 months after intervention.
Вмешательства
- Поведенческое Self-managed exercise therapy program
Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. - Процедура Partial wrist denervation
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
Первичные конечные точки
- PRWE [Срок оценки: 6 months]
Вторичные конечные точки (12)
- PRWE [Срок оценки: 3 months]
- PRWE [Срок оценки: 12 months]
- PRWE [Срок оценки: 5 years]
- Pain NRS [Срок оценки: 3 months]
- Pain NRS [Срок оценки: 6 months]
- Pain NRS [Срок оценки: 12 months]
- Pain NRS [Срок оценки: 5 years]
- EQ5D [Срок оценки: 3 months]
- EQ5D [Срок оценки: 6 months]
- EQ5D [Срок оценки: 12 months]
- EQ5D [Срок оценки: 5 years]
- GROC [Срок оценки: 3 months]
Критерии участия
Критерии включения
- Age ≥ 18 years.
- Chronic wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis.
- Radiological signs of osteoarthritis on posteroanterior and lateral radiograph.
Критерии исключения
- Previous PIN or AIN neurectomy.
- Rheumatoid arthritis or other chronic inflammatory arthritis.
- Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints.
- Ongoing infection.
- Inability to co-operate with the follow-up protocol.
- Systemic or intra-articular glucocorticoids or intraarticular PRP or Hyaluronic acid injections in the affected joint within 3 months prior to enrollment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Швеция · 2 центра
- Department of hand surgery, Malmo university hospital — Malmö
- Department of hand handsurgery, Södersjukhuset — Stockholm
Публикации
- Larsson SL, Tandrup T, Brogren E, Wilcke MK, Sward EM. Partial wrist denervation versus patient education and self-managed exercise therapy in patients with wrist osteoarthritis: study protocol for a randomized controlled trial. Trials. 2025 Oct 30;26(1):453. doi: 10.1186/s13063-025-09241-7. PMID 41168861
Идентификаторы
NCT: NCT06098586 · 2023-04885-01