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Идёт набор NCT07324343

Which Patient Group Shows Greater Improvement With Patient Education Alone in Rotator Cuff-Related Shoulder Pain? - A Cohort Study

Без фазы С лечением Shoulder Pain Syndrome Subacromial Pain Syndrome Rotator Cuff Related Shoulder Pain Patient Education

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: Questionnaire Validation, Patient Education.
Кому может быть актуально
Состояния в реестре: Shoulder Pain Syndrome, Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain, Patient Education. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary aim of this study is to determine the clinical effectiveness of patient education alone in individuals with rotator cuff-related shoulder pain and to identify which patient subgroups benefit more from this approach. In addition, the translation and cultural adaptation of the "Patient Knowledge Questionnaire (PKQ-RCRSP)" into Turkish will be carried out to measure the level of patient knowledge regarding patient education.

Подробное описание

Individuals who present with shoulder pain to the Orthopedics and Traumatology Department, Shoulder-Elbow Surgery Outpatient Clinic of Göztepe Prof. Dr. Süleyman Yalçın City Hospital and who volunteer to participate will be included in our study. Before beginning the study, the purpose of the study will be explained to the participants, and all information regarding the study will be provided both verbally and in writing. Informed consent will be obtained from participants, confirming that they voluntarily agree to take part in the study. A total of 116 participants will be included in the study, and the PKQ-RCRSP questionnaire will be administered at baseline and after one week. Following the validation process, participants will receive two face-to-face patient education sessions. After the first patient education session, pain will be assessed at the 4th, 12th, and 24th week follow-ups using the Numerical Pain Rating Scale (NPRS); functional limitation will be assessed using the Shoulder Pain and Disability Index (SPADI); clinical improvement using the Global Rating of Change Scale (GRC); illness perception using the Brief Illness Perception Questionnaire (B-IPQ); patient knowledge level using the PKQ-RCRSP; health literacy using the European Health Literacy Survey-Short Form (HLS-EU-Q6); and physical activity level using the International Physical Activity Questionnaire (IPAQ).

Вмешательства

  • Поведенческое Questionnaire Validation
    During the Turkish adaptation of the PKQ-RCRSP questionnaire, written permission was obtained from the original developer. At least two experts independently translated the questionnaire into Turkish, and a single reconciled version was created. This version was back-translated by an independent translator to ensure semantic and conceptual equivalence. Revisions were made following expert panel review and pilot testing. For validation, the PKQ-RCRSP will be administered to participants at basel
  • Поведенческое Patient Education
    Participants in this arm will receive structured patient education sessions for rotator cuff-related shoulder pain. The program consists of two 30-minute face-to-face sessions delivered by a physiotherapist with at least 5 years of experience in orthopedic rehabilitation. Educational topics include disease information, symptom management, treatment options, reducing fear of movement, exercise promotion, pain and stress management, physical activity recommendations, nutrition advice, and lifestyl

Первичные конечные точки

  • Numerical Pain Rating Scale (NPRS) [Срок оценки: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.]
Вторичные конечные точки (1)
  • Patient Knowledge Questionnaire (PKQ-RCRSP) [Срок оценки: Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.]

Критерии участия

Критерии включения

  • Individuals aged 18-65 years
  • Shoulder pain persisting for at least 4 weeks
  • Diagnosed by an orthopedic physician with impingement, subacromial bursitis, rotator cuff (RC) tendinopathy, or partial tear
  • Activity-related pain ≥3 on the NPRS
  • Cognitively able to understand the education and provide written informed consent

Критерии исключения

  • History of shoulder surgery
  • Diagnosis of frozen shoulder, full-thickness or massive rotator cuff (RC) tear, or instability
  • Presence of neurological or psychiatric conditions that prevent exercise
  • History of physical therapy-rehabilitation or injection treatment within the past 6 months
  • Pain persisting for more than 12 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul — Istanbul

Идентификаторы

NCT: NCT07324343 · 2150061

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗