- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07722845
Illness Perception and Treatment Expectations in Lateral Elbow Pain (LEP-IPTE)
20 juli 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Studietyp
Observationell
Inskrivning (Beräknad)
137
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hasan Gercek, PhD
- Telefonnummer: +90 542 648 8455
- E-post: hasan.gercek@acibadem.edu.tr
Studera Kontakt Backup
- Namn: Nuray Alaca, PhD
- Telefonnummer: +90 532 425 1290
- E-post: nuray.alaca@acibadem.edu.tr
Studieorter
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Istanbul, Turkiet (Türkiye)
- Dr. Fzt. Fatih Celik Ozel Saglik Birimi
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Kontakt:
- Hasan Gercek, PhD
- Telefonnummer: +90 542 648 8455
- E-post: hasan.gercek@acibadem.edu.tr
-
Huvudutredare:
- Hasan Gercek, PhD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Illness perception (Brief Illness Perception Questionnaire, B-IPQ)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain intensity (Numeric Rating Scale, NRS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Hasan Gercek, PhD, Acibadem University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
31 juli 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
5 januari 2027
Studieregistreringsdatum
Först inskickad
20 juli 2026
Först inskickad som uppfyllde QC-kriterierna
20 juli 2026
Första postat (Faktisk)
23 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AcibademHG1
Plan för individuella deltagardata (IPD)
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NEJ
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