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

13. Juni 2026 aktualisiert von: Ayşenur Yılmaz, Pamukkale University

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

59

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Shoulder Pain and Disability Index (SPADI)
Zeitfenster: Baseline and 6 weeks after rehabilitation
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Central Sensitization Inventory (CSI)
Zeitfenster: Baseline and 6 weeks after rehabilitation
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)
Zeitfenster: Baseline and 6 weeks after rehabilitation
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)
Zeitfenster: Baseline and 6 weeks after rehabilitation
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
Zeitfenster: Baseline and 6 weeks after rehabilitation
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
Zeitfenster: Baseline and 6 weeks after rehabilitation
Shoulder muscle strength will be evaluated using standardized clinical strength assessment procedures. Higher values indicate greater muscle strength.
Baseline and 6 weeks after rehabilitation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pamukkale University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juli 2026

Studienabschluss (Geschätzt)

1. August 2026

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • CS-Shoulder-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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