跳至主要内容
临床试验/NCT07324343
NCT07324343招募中不适用

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

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
116
试验地点
1
主要终点
Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Patient Education

Experimental

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

干预措施: Questionnaire Validation (Behavioral)

Patient Education

Experimental

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

干预措施: Patient Education (Behavioral)

结局指标

主要结局

Numerical Pain Rating Scale (NPRS)

时间窗: 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).

次要结局

  • 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.)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Koyuncu Cenikli

Research Asistant, PT

Istanbul University - Cerrahpasa

研究点 (1)

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