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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：ayşenur yılmaz, Assistant Professor, PT,PhD
- 電話番号：+905432833819
- メール：fzt.aysenurgungor@gmail.com
研究場所
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Türkiye
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Burdur、Türkiye、トルコ（Türkiye）、19300
- Burdur Mehmet Akif Ersoy Üniversitesi
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コンタクト：
- Ayşenur Yılmaz, Assistant Professor
- 電話番号：05432833819
- メール：fzt.aysenurgungor@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Central Sensitization Inventory (CSI)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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