Która grupa pacjentów wykazuje większą poprawę przy zastosowaniu samej edukacji pacjenta w przypadku bólu barku związanego z uszkodzeniem stożka rotatorów? - Badanie kohortowe
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Merve KOYUNCU CENİKLİ Research asistant, MSc
- Numer telefonu: +90(0212) 414 15 00
- E-mail: merve.cenikli@iuc.edu.tr
Lokalizacje studiów
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Istanbul, Turcja (Türkiye)
- Rekrutacyjny
- İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul
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Kontakt:
- Merve Koyuncu Cenikli Research Asistant, MSc
- Numer telefonu: +90(0212) 414 15 00
- E-mail: merve.cenikli@iuc.edu.tr
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Patient Education
Participants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain. |
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 baseline (V0). One week later (V1), the questionnaire will be repeated, and participants will be asked if their shoulder problem or knowledge has significantly changed in the past week. Those answering "Yes," who do not return, or who receive any intervention will be excluded from the test-retest analysis. Results from participants answering "No" will complete the test-retest analysis, and all participants' data will be included in other validity analyses. This concludes the validation phase. 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 lifestyle-specific guidance. Informational brochures will be provided after the first session. The second session, delivered two weeks later, focuses on reviewing progress and enhancing motivation; no new information will be provided. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Numerical Pain Rating Scale (NPRS)
Ramy czasowe: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Pain intensity assessed using the Numerical Pain Rating Scale (NPRS). |
İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient Knowledge Questionnaire (PKQ-RCRSP)
Ramy czasowe: Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
|
Patient knowledge regarding rotator cuff-related shoulder pain assessed |
Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI)
Ramy czasowe: Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Shoulder pain and functional disability assessed using the Shoulder Pain and Disability Index (SPADI). |
Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Sociodemographic Characteristics
Ramy czasowe: Baseline.
|
Sociodemographic characteristics including age, sex, education level, occupation, and other relevant demographic variables collected using a Sociodemographic Assessment Form. |
Baseline.
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Patient-Reported Global Change Assessed by the Global Rating of Change Scale (GRC)
Ramy czasowe: 4 weeks, 12 weeks, and 24 weeks after the start of the education program
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Patient-perceived overall change in condition assessed using the Global Rating of Change Scale (GRC). |
4 weeks, 12 weeks, and 24 weeks after the start of the education program
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Illness Perceptions Assessed by the Brief Illness Perception Questionnaire (B-IPQ)
Ramy czasowe: Baseline and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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Patient perceptions of illness assessed using the Brief Illness Perception Questionnaire (B-IPQ). |
Baseline and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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|
European Health Literacy Survey - Short Form (HLS-EU-Q6)
Ramy czasowe: Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
|
Health literacy level assessed using the European Health Literacy Survey - Short Form (HLS-EU-Q6). |
Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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|
European Health Literacy Survey - Short Form (HLS-EU-Q6).
Ramy czasowe: Baseline and at 12 weeks and 24 weeks after the start of the education program.
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Health literacy level assessed using the European Health Literacy Survey - Short Form (HLS-EU- |
Baseline and at 12 weeks and 24 weeks after the start of the education program.
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International Physical Activity Questionnaire - Short Form (IPAQ-SF / UFAA-KF)
Ramy czasowe: Baseline and at 12 weeks and 24 weeks after the start of the education program.
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Physical activity level assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). |
Baseline and at 12 weeks and 24 weeks after the start of the education program.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2150061
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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