Central Sensitization and Functional Outcomes in Chronic Shoulder Pain (SHOULDER-CS)

The Effects of Central Sensitization and Psychological Factors on Functional Outcomes Following Rehabilitation in Individuals With Chronic Shoulder Pain

This prospective observational cohort study aims to investigate whether baseline central sensitization and psychological factors predict functional outcomes following rehabilitation in individuals with chronic shoulder pain. Participants with chronic shoulder pain will receive a standardized 6-week physiotherapy and rehabilitation program routinely applied in the clinic. Assessments will be performed before and after treatment, including pain severity, shoulder function, central sensitization symptoms, and psychological factors such as pain catastrophizing. The findings of this study may contribute to a better understanding of biopsychosocial factors affecting rehabilitation outcomes in chronic shoulder pain and help improve individualized rehabilitation approaches.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Other: Physiotherapy Rehabilitation Program

Detailed Description

Chronic shoulder pain is one of the most common musculoskeletal disorders and is associated with pain, functional limitations, reduced quality of life, and work disability. Although structural abnormalities are often identified in clinical evaluation and imaging findings, the relationship between tissue pathology and symptom severity is not always clear. Therefore, factors beyond peripheral tissue damage may contribute to persistent shoulder pain and rehabilitation outcomes.

In recent years, central sensitization has become an important concept in chronic musculoskeletal pain conditions. Central sensitization refers to increased responsiveness of the central nervous system to sensory input, resulting in pain hypersensitivity and amplification of pain perception. Previous studies have demonstrated that individuals with chronic shoulder pain may present with symptoms related to central sensitization, which can negatively affect pain severity, disability, and treatment response.

Psychological factors such as pain catastrophizing, fear of movement, anxiety, and depression are also known to influence chronic pain experiences and rehabilitation outcomes. Higher levels of maladaptive psychological responses may contribute to increased pain perception, reduced treatment adherence, and poorer functional recovery. However, prospective studies evaluating the combined influence of central sensitization and psychological factors on rehabilitation outcomes in chronic shoulder pain remain limited.

This study is designed as a prospective observational cohort study. Individuals with chronic shoulder pain attending physiotherapy rehabilitation clinics will be recruited. Participants will undergo baseline assessments before treatment and follow-up assessments after a standardized 6-week rehabilitation program routinely applied in clinical practice.

The primary objective is to determine whether baseline central sensitization and psychological factors predict functional improvement following rehabilitation. The findings may contribute to a better understanding of the biopsychosocial mechanisms underlying treatment response and support the development of more individualized rehabilitation strategies for chronic shoulder pain management.

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

• Study Contact: Name: ayşenur yılmaz, Assistant Professor, PT,PhD; Phone Number: +905432833819; Email: fzt.aysenurgungor@gmail.com

Study Locations

• Turkey (Türkiye)
  • Türkiye
    • Burdur, Türkiye, Turkey (Türkiye), 19300
      • Burdur Mehmet Akif Ersoy Üniversitesi
      • Contact: Ayşenur Yılmaz, Assistant Professor; Phone Number: 05432833819; Email: fzt.aysenurgungor@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic shoulder pain who are referred to physiotherapy and rehabilitation clinics and scheduled to receive a standardized 6-week physiotherapy rehabilitation program. Participants will include individuals with shoulder pain associated with conditions such as rotator cuff-related shoulder pain, subacromial pain syndrome, and adhesive capsulitis.

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Presence of chronic shoulder pain lasting at least 3 months
• Clinical findings consistent with shoulder-related pain
• Willingness to participate in a 6-week physiotherapy rehabilitation program
• Ability to complete study assessments and questionnaires
• Provision of written informed consent

Exclusion Criteria:

• History of shoulder surgery within the previous 6 months
• Major shoulder trauma within the previous 6 months
• Serious pathology affecting the shoulder (e.g., infection, tumor, systemic inflammatory disease)
• Neurological disorders affecting the upper extremity (e.g., cervical radiculopathy, myelopathy, peripheral nerve injury)
• Severe cognitive impairment
• Communication problems preventing participation
• Shoulder injection within the previous 4 weeks
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Physiotherapy Rehabilitation Program; A standardized 6-week exercise-based physiotherapy and rehabilitation program including patient education, scapular stabilization exercises, strengthening exercises, range of motion exercises, functional training, and home exercise recommendations routinely applied in clinical practice.	Other: Physiotherapy Rehabilitation Program; A standardized 6-week exercise-based physiotherapy and rehabilitation program routinely applied in clinical practice, including patient education, scapular stabilization exercises, strengthening exercises, range of motion exercises, functional training, and home exercise recommendations for individuals with chronic shoulder pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a validated questionnaire used to assess shoulder pain and disability. Total scores range from 0 to 100, with higher scores indicating greater pain and disability.	Baseline and 6 weeks after rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Sensitization Inventory (CSI)	The Central Sensitization Inventory is a self-reported questionnaire assessing symptoms related to central sensitization. Scores range from 0 to 100, with higher scores indicating greater central sensitization symptoms.	Baseline and 6 weeks after rehabilitation
Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) assesses exaggerated negative thoughts and emotional responses related to pain. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.	Baseline and 6 weeks after rehabilitation
Pain Intensity (Visual Analog Scale)	Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.	Baseline and 6 weeks after rehabilitation
Shoulder Range of Motion	Shoulder range of motion will be assessed using standard goniometric measurements. Higher values indicate greater shoulder joint mobility.	Baseline and 6 weeks after rehabilitation
Shoulder Muscle Strength	Shoulder muscle strength will be evaluated using standardized clinical strength assessment procedures. Higher values indicate greater muscle strength.	Baseline and 6 weeks after rehabilitation

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 13, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Physical therapy; Central sensitization; Chronic shoulder pain
• Other Study ID Numbers: CS-Shoulder-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared due to privacy and confidentiality considerations. De-identified data may be available from the principal investigator upon reasonable request and with appropriate ethical approval.

Drug and device information, study documents

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