NCT07722845

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Illness perceptionTreatment expectationLateral epicondylalgiaPain catastrophizingFear-avoidance beliefsPain self-efficacyBiopsychosocial modelHierarchical regression

Outcome Measures

Primary Outcomes (2)

  • Illness perception (Brief Illness Perception Questionnaire, B-IPQ)

    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.

    Single assessment at enrollment (Day 1)

  • Treatment expectation (Treatment Expectation Questionnaire, TEX-Q)

    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.

    Single assessment at enrollment (Day 1)

Secondary Outcomes (5)

  • Pain intensity (Numeric Rating Scale, NRS)

    Single assessment at enrollment (Day 1)

  • Pain self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ)

    Single assessment at enrollment (Day 1)

  • Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire, FABQ)

    Single assessment at enrollment (Day 1)

  • Pain catastrophizing (Pain Catastrophizing Scale, PCS)

    Single assessment at enrollment (Day 1)

  • Elbow pain and function (Patient-Rated Tennis Elbow Evaluation, PRTEE)

    Single assessment at enrollment (Day 1)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Fzt. Fatih Celik Ozel Saglik Birimi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis ElbowTendinopathy

Condition Hierarchy (Ancestors)

Elbow TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Hasan Gercek, PhD

    Acibadem University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 5, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations