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RCRSP의 통증, 기능, 자기 효능 및 만족도에 대한 치료 환경의 영향

2026년 11월 2일 업데이트: Merve Koyuncu Cenikli, Istanbul University - Cerrahpasa

회전근개 관련 어깨통증의 치료환경이 통증, 기능, 자기효능감 및 만족도에 미치는 영향

Brief Summary

The aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. The main questions it aims answer are:

  • Is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.
  • Is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.

연구 개요

상세 설명

The investigators will include patients who applied to the physiotherapy clinic of Kadikoy Florence Nightingale Medical Center with the complaint of shoulder pain. 46 individuals who volunteer to participate in the study will be included. Participants will be randomised through a computer-based randomization program into two groups; the enriched therapeutic environment group (Group 1) and the isolated therapeutic environment group (Group 2). The same treatment including patient education, exercise therapy and ice application will be performed to both groups. Participants will receive a total of 15 sessions of treatment, 3 sessions per week. Before the treatment, 3rd week and 6th week, the following evaluations will be made to both groups; Numerical Pain Rating Scale (NPRS) to asses pain, Arm, Shoulder, Hand Problems Quick Survey (Quick-DASH) and Western Ontario Rotator Cuff Index (WORC) to asses functionality, Pain Self-Efficacy Questionnaire (PSEQ) to asses self efficacy and Global Scale of Change (GRC) to asses the effectiveness of the treatment.

연구 유형

중재적

등록 (실제)

34

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Istanbul, 터키 (Türkiye)
        • İstanbul University Cerrahpasa Faculty of Health Sciences

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 18-65 years old
  • diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy or partial rotator cuff tear
  • pain level between 3-7 according to visual analog scale
  • pain persisted for at least 3 months

Exclusion Criteria:

  • having a full-thickness or massive rotator cuff tear
  • history of shoulder surgery
  • having a musculoskeletal disease that prevents exercise
  • having a neurological disease or psychological disorder

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: The enriched therapeutic environment group (Group 1)

Group 1 will receive treatment in a physiotherapy unit which has following characteristics ; enlightened with sunlight, has a view of green trees and includes other participants exercising. This enviroment also had an intrumental music playing in the background. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest for 15 minutes of cold application.

It includes evaluation of the treatment process and past sessions. Simple shoulder biomechanics, function, and what caused the injury were explained to the patients. In order to increase patients' participation in treatment, it was emphasized what the treatment does and that the patient should cooperate in order to heal. During their treatment, patients are instructed to regulate their daily living activities, avoid overhead and repetitive movements of the arm, bags weighing more than 2-3 kg, etc. It was recommended not to carry them. Patients were informed about alternative sleeping positions.

Participants in both groups were included in a structured exercise program consisting of exercises recommended in the literature. This exercise program includes joint range of motion exercises, stretching exercises and strengthening exercises and was carried out under the supervision of a physiotherapist for 6 weeks. Joint range of motion and strengthening exercises are recommended as 3 sets of 10 repetitions, and stretching exercises are recommended as 5 repetitions for 20 seconds. Exercises appropriate to the patients' clinical conditions and progression were selected by the physiotherapist and included in the program.

Following each exercise treatment, cold-pack will be applied for 15 minutes. During col-pack application, patients in the Group 1 group will listen to classical music selected by us, while patients in the Group 2 will rest quietly. There are a total of 40 songs by Bach, Mozart, Beethoven and Andre Rieu on our CD player, and patients have the right to choose and listen to the song they want.

실험적: The isolated therapeutic environment group (Group 2).

Group 2 will receive treatment in a quiet single room. The room is illuminated by artificial light, curtains are closed so that patients cannot see outside view. Patients will receive a treatment consisting of patient education, exercise therapy and cold application for a total of 15 sessions, 3 times a week. Each session will last approximately 60 minutes. After the patient education and exercise therapy is completed, the participants will rest silently for 15 minutes of cold application.

It includes evaluation of the treatment process and past sessions. Simple shoulder biomechanics, function, and what caused the injury were explained to the patients. In order to increase patients' participation in treatment, it was emphasized what the treatment does and that the patient should cooperate in order to heal. During their treatment, patients are instructed to regulate their daily living activities, avoid overhead and repetitive movements of the arm, bags weighing more than 2-3 kg, etc. It was recommended not to carry them. Patients were informed about alternative sleeping positions.

Participants in both groups were included in a structured exercise program consisting of exercises recommended in the literature. This exercise program includes joint range of motion exercises, stretching exercises and strengthening exercises and was carried out under the supervision of a physiotherapist for 6 weeks. Joint range of motion and strengthening exercises are recommended as 3 sets of 10 repetitions, and stretching exercises are recommended as 5 repetitions for 20 seconds. Exercises appropriate to the patients' clinical conditions and progression were selected by the physiotherapist and included in the program.

Following each exercise treatment, cold-pack will be applied for 15 minutes. During col-pack application, patients in the Group 1 group will listen to classical music selected by us, while patients in the Group 2 will rest quietly. There are a total of 40 songs by Bach, Mozart, Beethoven and Andre Rieu on our CD player, and patients have the right to choose and listen to the song they want.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Numeric Pain Rating Scale (NPRS)
기간: Baseline, 3rd week, 6th week

Participants' pain at rest, at night and during activity was measured using the NPRS. The NPRS is an 11-point scale that can be scored from 0 to 10. A score of zero (0) indicates "no pain" and 10 indicates score defines "the most severe pain". The patient will be asked to mark shoulder pain on the scale

Baseline, 3rd week, 6th week

2차 결과 측정

결과 측정
측정값 설명
기간
Quick - The Disabilities of the Arm, Shoulder and Hand (Quick DASH) Questionnaire
기간: Baseline, 3rd week, 6th week

Q-DASH is a questionnaire developed to assess upper extremity functioning and symptoms based on self-report of patients. The total score of the scale ranges from 0-100 points and similar to SPADI, a high score is considered as high functional disability.

Baseline, 3rd week, 6th week
Western Ontario Rotator Cuff (WORC) Index
기간: Baseline, 3rd week, 6th week

WORC is a functional test which consists of 5 sections and a total of 21 questions assessing the physical symptoms, sports/leisure time activities, work, lifestyle, emotions that are affected by the shoulder problem. Each question is rated on a scale of 0-100 mm. Patients are scored between 0 and 2100 in total, with 2100 being the worst score.

Baseline, 3rd week, 6th week
Pain Self-Efficacy Questionnaire (PSEQ)
기간: Baseline, 6th week

The Pain and Self-Efficacy Questionnaire consists of 10 questions and it assesses multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: I am not at all confident, 6: I am completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.

Baseline, 6th week
Global Rating of Change, GRC
기간: Baseline, 3rd week, 6th week

The Global Rating of Change (GRC) is specifically designed to determine the impact of an intervention in musculoskeletal problems, to chart the clinical course of a condition and to measure a patient's improvement or deterioration over time. When using the GRC scale, the patient being assessed must have a certain cognitive level because the patient's ability to recall and measure the pre-treatment state is required. In our study, a scale consisting of 5 levels will be used (-2: much worse, -1: worse, 0: same, 1: better, 2: much better).

Baseline, 3rd week, 6th week

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 5월 6일

기본 완료 (실제)

2024년 10월 15일

연구 완료 (실제)

2024년 11월 15일

연구 등록 날짜

최초 제출

2024년 5월 27일

QC 기준을 충족하는 최초 제출

2024년 6월 7일

처음 게시됨 (실제)

2024년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 8월 1일

추가 정보

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