Illness Perception and Treatment Expectations in Lateral Elbow Pain (LEP-IPTE)

July 20, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illness perception (Brief Illness Perception Questionnaire, B-IPQ)
Time Frame: Single assessment at enrollment (Day 1)
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)
Time Frame: Single assessment at enrollment (Day 1)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity (Numeric Rating Scale, NRS)
Time Frame: Single assessment at enrollment (Day 1)
Self-reported lateral elbow pain intensity rated from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Single assessment at enrollment (Day 1)
Pain self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ)
Time Frame: Single assessment at enrollment (Day 1)
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.
Single assessment at enrollment (Day 1)
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire, FABQ)
Time Frame: Single assessment at enrollment (Day 1)
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.
Single assessment at enrollment (Day 1)
Pain catastrophizing (Pain Catastrophizing Scale, PCS)
Time Frame: Single assessment at enrollment (Day 1)
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.
Single assessment at enrollment (Day 1)
Elbow pain and function (Patient-Rated Tennis Elbow Evaluation, PRTEE)
Time Frame: Single assessment at enrollment (Day 1)
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.
Single assessment at enrollment (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Hasan Gercek, PhD, Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 5, 2027

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AcibademHG1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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