Effect of Central Sensitization on Response to Physical Therapy in Patients With Partial Supraspinatus Tear
研究概览
详细说明
This prospective observational study aims to investigate the impact of central sensitization on treatment response in patients with supraspinatus partial-thickness tears undergoing a standardized physical therapy and rehabilitation program. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and may contribute to persistent pain and functional impairment beyond the extent of structural tissue damage. Understanding its role may help explain the variability in clinical outcomes among patients receiving similar conservative treatments.
Adult patients diagnosed with a supraspinatus partial-thickness tear by clinical examination and magnetic resonance imaging (MRI) will be enrolled. Before treatment, demographic characteristics, clinical findings, pain intensity, shoulder function, and the presence of central sensitization will be assessed using validated outcome measures. All participants will receive the same standardized physical therapy protocol according to institutional practice.
After completion of the treatment program (e.g., 6 weeks), clinical assessments will be repeated to evaluate changes in pain and functional status. The primary objective is to compare treatment response between patients with and without central sensitization. Secondary analyses will examine the relationship between baseline central sensitization scores and the magnitude of improvement in clinical outcomes while adjusting for potential confounding variables such as age, sex, body mass index, symptom duration, and tear characteristics.
The study is observational in nature, and no experimental intervention, randomization, or additional invasive procedure will be performed beyond routine clinical evaluation and rehabilitation. The findings are expected to provide evidence regarding the prognostic significance of central sensitization in patients with supraspinatus partial-thickness tears and may contribute to the development of more individualized rehabilitation strategies.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Zeynep Karakuzu Güngör, M.D
- 电话号码:+90 (212) 404 15 00.
- 邮箱:zeynepkarakuzu@hotmail.com.tr
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
Adults aged 18 to 65 years. Diagnosis of supraspinatus partial-thickness tear confirmed by clinical examination and magnetic resonance imaging (MRI).
Presence of shoulder pain for at least 6 weeks. Candidates for a standardized physical therapy and rehabilitation program. Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
Full-thickness rotator cuff tear or history of previous shoulder surgery on the affected side.
Acute fracture, shoulder dislocation, or other major traumatic injury involving the affected shoulder.
Inflammatory rheumatic diseases, active infection, or malignancy affecting the musculoskeletal system.
Neurological disorders that may influence pain perception or upper extremity function (e.g., stroke, cervical myelopathy, peripheral neuropathy).
Severe glenohumeral or acromioclavicular osteoarthritis requiring surgical treatment.
Receipt of corticosteroid injection or any invasive shoulder intervention within the previous 3 months.
Participation in another structured rehabilitation program for the affected shoulder within the previous 3 months.
Pregnancy or inability to comply with the study protocol or complete the required questionnaires.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients with Central Sensitization
Patients with supraspinatus partial-thickness tears who are classified as having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the standardized physical therapy program.
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All participants will receive the same standardized physical therapy and rehabilitation program administered according to routine clinical practice.
The treatment program will include therapeutic exercises, stretching, strengthening, range-of-motion exercises, and appropriate physical therapy modalities as determined by the rehabilitation protocol.
No experimental intervention or additional procedure will be performed for research purposes.
The study is observational and aims to evaluate whether the presence of central sensitization influences the clinical response to the standardized rehabilitation program.
|
|
Patients without Central Sensitization
Patients with supraspinatus partial-thickness tears who are classified as not having central sensitization based on the Central Sensitization Inventory (CSI) at baseline and who receive the same standardized physical therapy program.
|
All participants will receive the same standardized physical therapy and rehabilitation program administered according to routine clinical practice.
The treatment program will include therapeutic exercises, stretching, strengthening, range-of-motion exercises, and appropriate physical therapy modalities as determined by the rehabilitation protocol.
No experimental intervention or additional procedure will be performed for research purposes.
The study is observational and aims to evaluate whether the presence of central sensitization influences the clinical response to the standardized rehabilitation program.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Shoulder Pain and Disability Index (SPADI) Total Score
大体时间:Baseline, Week 3, and Week 6
|
The Shoulder Pain and Disability Index (SPADI) total score will be assessed at baseline, the end of treatment, and 6 weeks after completion of treatment to evaluate changes in pain and shoulder-related disability.
A greater reduction in the SPADI total score indicates a better treatment response.
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Baseline, Week 3, and Week 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
大体时间:Baseline, Week 3, and Week 6
|
Pain intensity will be assessed using the Visual Analog Scale (VAS).
Changes in VAS scores will be evaluated to determine the effect of treatment over time.
|
Baseline, Week 3, and Week 6
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KSUH-SS-RCPT-2026-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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