Lateral EpicondylitisNCT06642103
Pain, Muscle Strength, Motor Imagery, Body Awareness on Function and Individuals With Chronic Lateral Epicondylitis
An observational study of Lateral Epicondylitis, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of muscle strength, pain, motor imagery and body awareness on function in individuals with lateral epicondylitis. The main question it aims to answer is: Do pain, motor imagery, muscle strength and body awareness have an impact on function in individuals with lateral… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 28 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lateral epicondylitis
Who may be able to join
- a diagnosis of chronic LET by a physician and
- a pain score > 3 on a visual analog scale (VAS).
Who cannot join
- concomitant disorders of the wrist and forearm, such as elbow fracture or dislocation, and treatment with corticosteroid injections within the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pain, Muscle Strength, Motor Imagery and Body Awareness on Function in Individuals With Chronic Lateral Epicondylitis
The aim of this study was to examine the effect of muscle strength, pain, motor imagery and body awareness on function in individuals with lateral epicondylitis. The main question it aims to answer is: Do pain, motor imagery, muscle strength and body awareness have an impact on function in individuals with lateral epicondylitis?
- Conditions
- Lateral Epicondylitis
- Medical subject headings
- Tennis Elbow
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Fuction will be evaluated with Patient-Rated Tennis Elbow Evaluation. The Patient-Rated Tennis Elbow Evaluation (PRTEE), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale - 5 items (0 = no pain, 10 = worst imaginable) Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items
Measured: baseline
Secondary outcomes (4)
Pain severity
The rest, activity and night pains of the participants will be evaluated with a 10 cm Visual Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.
Measured: Baseline
Motor imagery
Motor imagery will be assessed through a left/right judgment task in which participants will need to recognize whether hand images correspond to their left or right side using the Recognise™ application (Neuro Orthopaedic Institute, Adelaide, Australia). For this test, participants will be seated comfortably in front of a table, with both elbows flexed at 90◦ and both index fingers placed on the bottom of the screen of an electronic tablet. Forty images of hands (20 on each side) in multiple postures, angles and skin colors will be randomly displayed in the center of the screen of the device. Participants will be given standard instructions to decide as quickly and accurately as possible whether each image is of the right or left hand by clicking on the 'left' (with left fingers) or 'right' (with right fingers) buttons shown at the bottom of the screen.
Measured: Baseline
Grip strength
The maximal grip strength of the patients will be measured with a hydraulic hand dynamometer.
Measured: Baseline
The Body Awareness
The Body Awareness Questionnaire will be used to assess body awareness. The questionnaire consists of 18 questions. Participants will be asked to score each statement on a scale ranging from 1 (1: Not true at all) to 7 (7: Completely true) and the total score will be obtained by summing the score given for each statement.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Gerçek, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642103
- Sponsor's protocol ID
- KaratayUH13
- Status last verified
- Apr 2025
- First submitted
- 10 Oct 2024
- Last updated
- 29 Apr 2025
- 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 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain, Muscle Strength, Motor Imagery and Body Awareness on Function in Individuals With Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06642103
- Acronym / sponsor ID
- KaratayUH13
- Conditions
- Lateral Epicondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 15 Oct 2024 (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.
The aim of this study was to examine the effect of muscle strength, pain, motor imagery and body awareness on function in individuals with lateral epicondylitis. The main question it aims to answer is: Do pain, motor imagery, muscle strength and body awareness have an impact on function in individuals with lateral epicondylitis?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lateral epicondylitis
Key inclusion criteria (2 listed)
- a diagnosis of chronic LET by a physician and
- a pain score > 3 on a visual analog scale (VAS).
Key exclusion criteria (1 listed)
- concomitant disorders of the wrist and forearm, such as elbow fracture or dislocation, and treatment with corticosteroid injections within the previous 6 months
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
Function
Time frame: baseline
Fuction will be evaluated with Patient-Rated Tennis Elbow Evaluation. The Patient-Rated Tennis Elbow Evaluation (PRTEE), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale - 5 items (0 = no pain, 10 = worst imaginable) Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items
4 secondary outcomes
Pain severity
Time frame: Baseline
Motor imagery
Time frame: Baseline
Grip strength
Time frame: Baseline
The Body Awareness
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Epicondylitis, run by KTO Karatay 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function (time frame: baseline). 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 29 Apr 2025.