- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07654023
Central Sensitization and Functional Outcomes in Chronic Shoulder Pain (SHOULDER-CS)
The Effects of Central Sensitization and Psychological Factors on Functional Outcomes Following Rehabilitation in Individuals With Chronic Shoulder Pain
연구 개요
상세 설명
Chronic shoulder pain is one of the most common musculoskeletal disorders and is associated with pain, functional limitations, reduced quality of life, and work disability. Although structural abnormalities are often identified in clinical evaluation and imaging findings, the relationship between tissue pathology and symptom severity is not always clear. Therefore, factors beyond peripheral tissue damage may contribute to persistent shoulder pain and rehabilitation outcomes.
In recent years, central sensitization has become an important concept in chronic musculoskeletal pain conditions. Central sensitization refers to increased responsiveness of the central nervous system to sensory input, resulting in pain hypersensitivity and amplification of pain perception. Previous studies have demonstrated that individuals with chronic shoulder pain may present with symptoms related to central sensitization, which can negatively affect pain severity, disability, and treatment response.
Psychological factors such as pain catastrophizing, fear of movement, anxiety, and depression are also known to influence chronic pain experiences and rehabilitation outcomes. Higher levels of maladaptive psychological responses may contribute to increased pain perception, reduced treatment adherence, and poorer functional recovery. However, prospective studies evaluating the combined influence of central sensitization and psychological factors on rehabilitation outcomes in chronic shoulder pain remain limited.
This study is designed as a prospective observational cohort study. Individuals with chronic shoulder pain attending physiotherapy rehabilitation clinics will be recruited. Participants will undergo baseline assessments before treatment and follow-up assessments after a standardized 6-week rehabilitation program routinely applied in clinical practice.
The primary objective is to determine whether baseline central sensitization and psychological factors predict functional improvement following rehabilitation. The findings may contribute to a better understanding of the biopsychosocial mechanisms underlying treatment response and support the development of more individualized rehabilitation strategies for chronic shoulder pain management.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: ayşenur yılmaz, Assistant Professor, PT,PhD
- 전화번호: +905432833819
- 이메일: fzt.aysenurgungor@gmail.com
연구 장소
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Türkiye
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Burdur, Türkiye, 터키 (Türkiye), 19300
- Burdur Mehmet Akif Ersoy Üniversitesi
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연락하다:
- Ayşenur Yılmaz, Assistant Professor
- 전화번호: 05432833819
- 이메일: fzt.aysenurgungor@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adults aged 18 years and older
- Presence of chronic shoulder pain lasting at least 3 months
- Clinical findings consistent with shoulder-related pain
- Willingness to participate in a 6-week physiotherapy rehabilitation program
- Ability to complete study assessments and questionnaires
- Provision of written informed consent
Exclusion Criteria:
- History of shoulder surgery within the previous 6 months
- Major shoulder trauma within the previous 6 months
- Serious pathology affecting the shoulder (e.g., infection, tumor, systemic inflammatory disease)
- Neurological disorders affecting the upper extremity (e.g., cervical radiculopathy, myelopathy, peripheral nerve injury)
- Severe cognitive impairment
- Communication problems preventing participation
- Shoulder injection within the previous 4 weeks
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Physiotherapy Rehabilitation Program
A standardized 6-week exercise-based physiotherapy and rehabilitation program including patient education, scapular stabilization exercises, strengthening exercises, range of motion exercises, functional training, and home exercise recommendations routinely applied in clinical practice.
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A standardized 6-week exercise-based physiotherapy and rehabilitation program routinely applied in clinical practice, including patient education, scapular stabilization exercises, strengthening exercises, range of motion exercises, functional training, and home exercise recommendations for individuals with chronic shoulder pain.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI)
기간: Baseline and 6 weeks after rehabilitation
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The Shoulder Pain and Disability Index (SPADI) is a validated questionnaire used to assess shoulder pain and disability.
Total scores range from 0 to 100, with higher scores indicating greater pain and disability.
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Baseline and 6 weeks after rehabilitation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Central Sensitization Inventory (CSI)
기간: Baseline and 6 weeks after rehabilitation
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The Central Sensitization Inventory is a self-reported questionnaire assessing symptoms related to central sensitization.
Scores range from 0 to 100, with higher scores indicating greater central sensitization symptoms.
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Baseline and 6 weeks after rehabilitation
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Pain Catastrophizing Scale (PCS)
기간: Baseline and 6 weeks after rehabilitation
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The Pain Catastrophizing Scale (PCS) assesses exaggerated negative thoughts and emotional responses related to pain.
Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Baseline and 6 weeks after rehabilitation
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Pain Intensity (Visual Analog Scale)
기간: Baseline and 6 weeks after rehabilitation
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Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline and 6 weeks after rehabilitation
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Shoulder Range of Motion
기간: Baseline and 6 weeks after rehabilitation
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Shoulder range of motion will be assessed using standard goniometric measurements.
Higher values indicate greater shoulder joint mobility.
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Baseline and 6 weeks after rehabilitation
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Shoulder Muscle Strength
기간: Baseline and 6 weeks after rehabilitation
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Shoulder muscle strength will be evaluated using standardized clinical strength assessment procedures.
Higher values indicate greater muscle strength.
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Baseline and 6 weeks after rehabilitation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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