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

13. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

59

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pamukkale University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CS-Shoulder-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kroniske skuldersmerter

Kliniske forsøg med Physiotherapy Rehabilitation Program

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