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

NCT ID: NCT07324343

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-01

Brief Summary

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.

Detailed Description

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).

Conditions

Shoulder Pain Syndrome; Subacromial Pain Syndrome; Rotator Cuff Related Shoulder Pain; Patient Education

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Education

Participants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain.

Group Type: EXPERIMENTAL

Questionnaire Validation

Intervention Type: BEHAVIORAL

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.

Patient Education

Intervention Type: BEHAVIORAL

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.

Interventions

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 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.

Intervention Type: BEHAVIORAL

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 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Merve Koyuncu Cenikli

Research Asistant, PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Merve KOYUNCU CENİKLİ Research asistant, MSc

Role: CONTACT

merve.cenikli@iuc.edu.tr

+90(0212) 414 15 00

Facility Contacts

Merve Koyuncu Cenikli Research Asistant, MSc

Role: primary

merve.cenikli@iuc.edu.tr

+90(0212) 414 15 00

Other Identifiers

2150061

Identifier Type: -

Identifier Source: org_study_id