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

NCT07324343 | Recruiting

• 1 other identifier: 2150061
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

patient education; Rotator Cuff Related Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NPRS)

  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.

Secondary Outcomes (1)

• Patient Knowledge Questionnaire (PKQ-RCRSP)

  Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.

Other Outcomes (7)

• Shoulder Pain and Disability Index (SPADI)

  Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.

• Sociodemographic Characteristics

  Baseline.

• Patient-Reported Global Change Assessed by the Global Rating of Change Scale (GRC)

  4 weeks, 12 weeks, and 24 weeks after the start of the education program

Study Arms (1)

Patient Education

EXPERIMENTAL

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

Behavioral: Questionnaire Validation; Behavioral: Patient Education

Interventions

Questionnaire Validation 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

Patient Education 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.

Patient Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Merve KOYUNCU CENİKLİ Research asistant, MSc

CONTACT

+90(0212) 414 15 00; merve.cenikli@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant, PT

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 7, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)