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

13. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

59

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Türkiye
      • Burdur, Türkiye, Tyrkia (Türkiye), 19300
        • Burdur Mehmet Akif Ersoy Üniversitesi
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Shoulder Pain and Disability Index (SPADI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Central Sensitization Inventory (CSI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pamukkale University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

30. juli 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

13. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CS-Shoulder-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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