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Not yet recruitingNCT07664137Updated Jun 24, 2026

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

An observational study in Rotator Cuff Tears, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Rotator Cuff Tears

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03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Standard Physical Therapy and Rehabilitation

  • 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.

    Behavioral: Standard Physical Therapy and Rehabilitation

Interventions

  • BehavioralStandard 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 the presence of central sensitization influences the clinical response to the standardized rehabilitation program.

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What researchers measure

Primary outcomes

  1. Change in Shoulder Pain and Disability Index (SPADI) Total Score

    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.

    Time frame: Baseline, Week 3, and Week 6

Secondary outcomes

  1. Change in Visual Analog Scale (VAS) Pain Score

    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.

    Time frame: Baseline, Week 3, and Week 6

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

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

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07664137
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Zeynep Karakuzu Güngör (Specialist Physician in Physical Medicine and Rehabilitation, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jun 24, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Jun 24, 2026

Study contacts

Zeynep Karakuzu Güngör, M.D
Contact
zeynepkarakuzu@hotmail.com.tr
+90 (212) 404 15 00.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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