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

NCT07664137 | Not Yet Recruiting

• 1 other identifier: KSUH-SS-RCPT-2026-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rotator Cuff Tears

Outcome Measures

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.

  Baseline, Week 3, and Week 6

Secondary Outcomes (1)

• Change in Visual Analog Scale (VAS) Pain Score

  Baseline, Week 3, and Week 6

Study Arms (2)

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

Standard Physical Therapy and Rehabilitation BEHAVIORAL

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 with Central Sensitization; Patients without Central Sensitization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Zeynep Karakuzu Güngör, M.D

CONTACT

+90 (212) 404 15 00.; zeynepkarakuzu@hotmail.com.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 24, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share