NCT07654023

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Aug 2026

First Submitted

Initial submission to the registry

June 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 4, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

Chronic shoulder painCentral sensitizationPhysical therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Central Sensitization Inventory (CSI)

    Baseline and 6 weeks after rehabilitation

  • Pain Catastrophizing Scale (PCS)

    Baseline and 6 weeks after rehabilitation

  • Pain Intensity (Visual Analog Scale)

    Baseline and 6 weeks after rehabilitation

  • Shoulder Range of Motion

    Baseline and 6 weeks after rehabilitation

  • Shoulder Muscle Strength

    Baseline and 6 weeks after rehabilitation

Study Arms (1)

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

Interventions

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.

Physiotherapy Rehabilitation Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy Üniversitesi

Burdur, Türkiye, 19300, Turkey (Türkiye)

Location

Central Study Contacts

ayşenur yılmaz, Assistant Professor, PT,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 17, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations