- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07722845
Illness Perception and Treatment Expectations in Lateral Elbow Pain (LEP-IPTE)
20. juli 2026 oppdatert av: Hasan Gerçek, Acibadem University
Determining the Predictors of Illness Perception and Treatment Expectations in Individuals With Lateral Elbow Pain: A Cross-Sectional Study
This cross-sectional, correlational study aims to determine the predictors of illness perception and treatment expectations in adults with chronic lateral elbow pain.
Sociodemographic characteristics, clinical findings (pain intensity, pain duration, elbow-specific function) and psychosocial variables (pain self-efficacy, fear-avoidance beliefs, pain catastrophizing) will be examined as candidate predictors of two patient-centred constructs: illness perception, measured with the Brief Illness Perception Questionnaire, and treatment expectation, measured with the Treatment Expectation Questionnaire.
Data will be analysed using hierarchical multiple linear regression in three predictor blocks.
The study is reported according to the STROBE statement.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Observasjonsmessig
Registrering (Antatt)
137
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hasan Gercek, PhD
- Telefonnummer: +90 542 648 8455
- E-post: hasan.gercek@acibadem.edu.tr
Studer Kontakt Backup
- Navn: Nuray Alaca, PhD
- Telefonnummer: +90 532 425 1290
- E-post: nuray.alaca@acibadem.edu.tr
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Dr. Fzt. Fatih Celik Ozel Saglik Birimi
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Ta kontakt med:
- Hasan Gercek, PhD
- Telefonnummer: +90 542 648 8455
- E-post: hasan.gercek@acibadem.edu.tr
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Hovedetterforsker:
- Hasan Gercek, PhD
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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 presenting with lateral elbow pain to a physiotherapy and rehabilitation outpatient unit in Istanbul, Turkey.
Consecutive, non-probability sampling of eligible patients who consent to participate.
Beskrivelse
Inclusion Criteria:
- Aged 18 years or older
- Diagnosis of lateral epicondylalgia or lateral elbow pain made by an orthopaedic surgeon or physiatrist
- Pain intensity of at least 4 on the Numeric Rating Scale
- Pain duration of at least 12 weeks (chronic)
- Willing to provide written informed consent
Exclusion Criteria:
- History of any surgical procedure of the upper extremity
- Cervical spine pathology
- Inflammatory arthritis affecting the wrist or finger joints (e.g. rheumatoid arthritis)
- Active neurological disease or radiculopathy radiating to the upper extremity
- Diagnosis of fibromyalgia or another widespread pain syndrome
- Currently receiving active psychiatric treatment (e.g. psychosis, severe depression)
- Pregnancy
- Visual or cognitive impairment of a degree that would prevent completion of the questionnaires
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 |
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Adults with chronic lateral elbow pain
Adults aged 18 years or older, diagnosed with lateral epicondylalgia or lateral elbow pain by an orthopaedic surgeon or physiatrist, with pain of at least 4 out of 10 on the Numeric Rating Scale lasting 12 weeks or longer.
Participants complete a single battery of self-report questionnaires; no intervention is applied.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Illness perception (Brief Illness Perception Questionnaire, B-IPQ)
Tidsramme: Single assessment at enrollment (Day 1)
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The B-IPQ is a 9-item self-report instrument assessing cognitive and emotional representations of illness.
Eight items are rated on a 0 to 10 numeric scale covering consequences, timeline, personal control, treatment control, identity, concern, coherence and emotional representation; the ninth item is open-ended and asks about perceived causes.
The total score ranges from 0 to 80, with higher scores indicating a more threatening perception of the illness.
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Single assessment at enrollment (Day 1)
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Treatment expectation (Treatment Expectation Questionnaire, TEX-Q)
Tidsramme: Single assessment at enrollment (Day 1)
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The TEX-Q assesses expectations of an upcoming treatment.
Fifteen scored items are rated on an 11-point scale from 0 (no expectation at all) to 10 (expecting complete recovery from treatment); six additional items are not included in scoring.
Higher scores indicate higher treatment expectation.
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Single assessment at enrollment (Day 1)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity (Numeric Rating Scale, NRS)
Tidsramme: Single assessment at enrollment (Day 1)
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Self-reported lateral elbow pain intensity rated from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
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Single assessment at enrollment (Day 1)
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Pain self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ)
Tidsramme: Single assessment at enrollment (Day 1)
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Ten items rated on a 7-point Likert scale (0 = not at all confident, 6 = completely confident), giving a total score of 0 to 60. Higher scores indicate greater confidence in performing activities despite pain.
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Single assessment at enrollment (Day 1)
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Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire, FABQ)
Tidsramme: Single assessment at enrollment (Day 1)
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Sixteen items rated on a 7-point Likert scale from 0 (completely disagree) to 6 (completely agree), assessing beliefs about the effect of physical activity and work on pain.
Higher scores indicate stronger fear-avoidance beliefs.
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Single assessment at enrollment (Day 1)
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Pain catastrophizing (Pain Catastrophizing Scale, PCS)
Tidsramme: Single assessment at enrollment (Day 1)
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Thirteen items with helplessness, magnification and rumination subscales, each rated from 0 (never) to 4 (all the time), giving a total score of 0 to 52.
Higher scores indicate greater pain catastrophizing.
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Single assessment at enrollment (Day 1)
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Elbow pain and function (Patient-Rated Tennis Elbow Evaluation, PRTEE)
Tidsramme: Single assessment at enrollment (Day 1)
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Fifteen items covering pain (5 items) and function (6 specific activity items and 4 usual activity items) over the past week.
The total score ranges from 0 to 100, with higher scores indicating greater pain and loss of function.
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Single assessment at enrollment (Day 1)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Hasan Gercek, PhD, Acibadem 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)
31. juli 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
5. januar 2027
Datoer for studieregistrering
Først innsendt
20. juli 2026
Først innsendt som oppfylte QC-kriteriene
20. juli 2026
Først lagt ut (Faktiske)
23. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AcibademHG1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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