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NCT Number: NCT07722845

Illness Perception and Treatment Expectations in Lateral Elbow Pain

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.

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Key information

Conditions

Lateral Elbow Pain Arm Injuries Chronic Musculoskeletal Pain Elbow Injuries Elbow Tendinopathy Lateral Epicondylitis Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Fzt. Fatih Celik Ozel Saglik Birimi

Istanbul, Turkey (Türkiye)

Location contact

Hasan Gercek, PhD

CONTACT

[email protected]

+90 542 648 8455

Hasan Gercek, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hasan Gercek, PhD

CONTACT

[email protected]

+90 542 648 8455

Nuray Alaca, PhD

CONTACT

[email protected]

+90 532 425 1290

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Determining the Predictors of Illness Perception and Treatment Expectations in Individuals With Lateral Elbow Pain: A Cross-Sectional Study

Acronym: LEP-IPTE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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