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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Behavioral: Standard Physical Therapy and Rehabilitation

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Zeynep Karakuzu Güngör, M.D; Phone Number: +90 (212) 404 15 00.; Email: zeynepkarakuzu@hotmail.com.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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 the presence of central sensitization influences the clinical response to the standardized rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 3, and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 3, and Week 6

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: KSUH-SS-RCPT-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No. Individual participant data collected during this study will not be shared publicly because of participant confidentiality and institutional data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No