NCT06642103

Brief 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 epicondylitis?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

October 10, 2024

Last Update Submit

April 28, 2025

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Secondary Outcomes (4)

  • Pain severity

    Baseline

  • Motor imagery

    Baseline

  • Grip strength

    Baseline

  • The Body Awareness

    Baseline

Eligibility Criteria

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

Lateral epicondylitis

You may qualify if:

  • a diagnosis of chronic LET by a physician and
  • a pain score \> 3 on a visual analog scale (VAS).

You may not qualify if:

  • concomitant disorders of the wrist and forearm, such as elbow fracture or dislocation, and treatment with corticosteroid injections within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

October 15, 2024

Primary Completion

April 28, 2025

Study Completion

April 28, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)