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Not yet recruiting NCT07664137

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

Observational Rotator Cuff Tears

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Physical Therapy and Rehabilitation.
Who it may be relevant to
Registry conditions: Rotator Cuff Tears. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Standard Physical Therapy and Rehabilitation
    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

Primary outcome measures

  • Change in Shoulder Pain and Disability Index (SPADI) Total Score [Time frame: Baseline, Week 3, and Week 6]
Secondary outcome measures (1)
  • Change in Visual Analog Scale (VAS) Pain Score [Time frame: Baseline, Week 3, and Week 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07664137 · KSUH-SS-RCPT-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗