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

December 24, 2025 updated by: Merve Koyuncu Cenikli, Istanbul University - Cerrahpasa
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Education
Participants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain.
Behavioral: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Pain Rating Scale (NPRS)
Time Frame: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Knowledge Questionnaire (PKQ-RCRSP)
Time Frame: 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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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.
Sociodemographic Characteristics
Time Frame: Baseline.
Sociodemographic characteristics including age, sex, education level, occupation, and other relevant demographic variables collected using a Sociodemographic Assessment Form.
Baseline.
Patient-Reported Global Change Assessed by the Global Rating of Change Scale (GRC)
Time Frame: 4 weeks, 12 weeks, and 24 weeks after the start of the education program
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
Illness Perceptions Assessed by the Brief Illness Perception Questionnaire (B-IPQ)
Time Frame: Baseline and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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.
European Health Literacy Survey - Short Form (HLS-EU-Q6)
Time Frame: 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.
European Health Literacy Survey - Short Form (HLS-EU-Q6).
Time Frame: Baseline and at 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-
Baseline and at 12 weeks and 24 weeks after the start of the education program.
International Physical Activity Questionnaire - Short Form (IPAQ-SF / UFAA-KF)
Time Frame: Baseline and at 12 weeks and 24 weeks after the start of the education program.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2150061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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