Lateral Elbow PainLEP-IPTENCT07722845
Illness Perception and Treatment Expectations in Lateral Elbow Pain
An observational study of Lateral Elbow Pain and Lateral Epicondylitis, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Elbow Pain, Lateral Epicondylitis, Tennis Elbow
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2026to 5 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Dr. Fzt. Fatih Celik Ozel Saglik Birimi
Istanbul
Hasan Gercek, PhD, +90 542 648 8455, hasan.gercek@acibadem.edu.tr
Hasan Gercek, PhD
About this study
Official title: 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.
- Conditions
- Lateral Elbow Pain, Lateral Epicondylitis, Tennis Elbow, Chronic Musculoskeletal Pain, Tendinopathy
- Keywords
- Illness perception, Treatment expectation, Lateral epicondylalgia, Pain catastrophizing, Fear-avoidance beliefs, Pain self-efficacy, Biopsychosocial model, Hierarchical regression
- Medical subject headings
- Tennis Elbow, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Single assessment at enrollment (Day 1)
Secondary outcomes (5)
Pain intensity (Numeric Rating Scale, NRS)
Self-reported lateral elbow pain intensity rated from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Single assessment at enrollment (Day 1)
Pain self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ)
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.
Measured: Single assessment at enrollment (Day 1)
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire, FABQ)
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.
Measured: Single assessment at enrollment (Day 1)
Pain catastrophizing (Pain Catastrophizing Scale, PCS)
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.
Measured: Single assessment at enrollment (Day 1)
Elbow pain and function (Patient-Rated Tennis Elbow Evaluation, PRTEE)
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.
Measured: Single assessment at enrollment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Elbow PainStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Gerçek, Acibadem University
- Investigators
- Hasan Gercek, PhD, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722845
- Sponsor's protocol ID
- AcibademHG1
- Acronym
- LEP-IPTE
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Predictors of Illness Perception and Treatment Expectations in Individuals With Lateral Elbow Pain: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07722845
- Acronym / sponsor ID
- LEP-IPTE / AcibademHG1
- Conditions
- Lateral Elbow Pain, Lateral Epicondylitis, Tennis Elbow, Chronic Musculoskeletal Pain, Tendinopathy
- Keywords
- Illness perception, Treatment expectation, Lateral epicondylalgia, Pain catastrophizing, Fear-avoidance beliefs, Pain self-efficacy, Biopsychosocial model, Hierarchical regression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
Pain intensity (Numeric Rating Scale, NRS)
Time frame: Single assessment at enrollment (Day 1)
Pain self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ)
Time frame: Single assessment at enrollment (Day 1)
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire, FABQ)
Time frame: Single assessment at enrollment (Day 1)
Pain catastrophizing (Pain Catastrophizing Scale, PCS)
Time frame: Single assessment at enrollment (Day 1)
Elbow pain and function (Patient-Rated Tennis Elbow Evaluation, PRTEE)
Time frame: Single assessment at enrollment (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hasan Gercek, PhD principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Elbow Pain and Lateral Epicondylitis, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan Gercek, PhD (+90 542 648 8455, hasan.gercek@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness perception (Brief Illness Perception Questionnaire, B-IPQ) (time frame: Single assessment at enrollment (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.