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

I

Istanbul University - Cerrahpasa

Status

Enrolling

Conditions

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

Treatments

Behavioral: Patient Education
Behavioral: Questionnaire Validation

Study type

Interventional

Funder types

Other

Identifiers

NCT07324343
2150061

Details and patient eligibility

About

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.

Full 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).

Enrollment

116 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

116 participants in 1 patient group

Patient Education
Experimental group
Description:
Participants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain.
Treatment:
Behavioral: Questionnaire Validation
Behavioral: Patient Education

Trial contacts and locations

1

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Central trial contact

Merve KOYUNCU CENİKLİ Research asistant, MSc

Data sourced from clinicaltrials.gov

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