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Effect of Central Sensitization on Response to Physical Therapy in Patients With Partial Supraspinatus Tear

2026年6月17日 更新者:Zeynep Karakuzu Güngör、Kanuni Sultan Suleyman Training and Research Hospital
This prospective observational study aims to investigate whether central sensitization influences the response to physical therapy in patients with partial supraspinatus tendon tears. Participants will undergo standardized clinical evaluation before treatment and after a 6-week physical therapy program. Pain intensity, shoulder function, disability, and central sensitization-related symptoms will be assessed using validated outcome measures. The study seeks to determine the relationship between baseline central sensitization status and treatment outcomes, thereby identifying factors that may predict rehabilitation success and support individualized treatment strategies for patients with partial supraspinatus tears.

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

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population will consist of adult patients aged 18-65 years who are diagnosed with supraspinatus partial-thickness tears based on clinical examination and magnetic resonance imaging (MRI) and are referred for conservative treatment. Participants will be recruited from the outpatient Physical Medicine and Rehabilitation clinic. Eligible patients who meet the inclusion criteria and provide written informed consent will be enrolled consecutively. All participants will receive the same standardized physical therapy and rehabilitation program and will be evaluated at baseline, at the end of treatment, and 6 weeks after completion of treatment.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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.
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.
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月30日

初级完成 (估计的)

2026年11月15日

研究完成 (估计的)

2026年11月30日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

No. Individual participant data collected during this study will not be shared publicly because of participant confidentiality and institutional data protection policies.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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