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Upper Extremity-based Exercises and Elbow-focused Exercises in LET

Primary Purpose

Lateral Epicondylitis, Elbow Tendinopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elbow focused rehabilitation
Scapular and rotator cuff muscles strengthening
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring tendinopathy, elbow

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cases are between the ages of 18-65 Getting a diagnosis of unilateral lateral elbow tendinopathy At least two positive Thomsen, Maudsley's Mill's and Cozen tests on clinical examination Continuing symptoms for at least 3 months The absence of any chronic disease that would prevent participation in the treatment program Exclusion Criteria: History of trauma or surgery in the involved elbow joint Having orthopedic problems in the cervical spine, shoulder joint or wrist To have participated in the rehabilitation program in the last 3 months Corticosteroid injection application in the last 3 months Systemic arthritis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Shoulder and scapular strengthening group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Numeric Pain Rating Scale (NPRS)
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Numeric Pain Rating Scale (NPRS)
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Numeric Pain Rating Scale (NPRS)
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Numeric Pain Rating Scale (NPRS)
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.

    Secondary Outcome Measures

    Pain Pressure Threshold (PPT)
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Pain Pressure Threshold (PPT)
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Pain Pressure Threshold (PPT)
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Pain Pressure Threshold (PPT)
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Hand Grip Strength
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Hand Grip Strength
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Hand Grip Strength
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Hand Grip Strength
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Pain-free Hand Grip Strength
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Pain-free Hand Grip Strength
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Pain-free Hand Grip Strength
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Pain-free Hand Grip Strength
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.

    Full Information

    First Posted
    June 6, 2022
    Last Updated
    March 30, 2023
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05809622
    Brief Title
    Upper Extremity-based Exercises and Elbow-focused Exercises in LET
    Official Title
    Comparison of the Effectiveness of Upper Extremity-based Exercises and Elbow-focused Exercises in Lateral Elbow tendiNopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 10, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to investigate the effects of rotator cuff and scapular muscle strengthening exercises applied in addition to the 8-week elbow focused rehabilitation program in lateral elbow tendinopathy, by comparing it with the elbow focused rehabilitation program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lateral Epicondylitis, Elbow Tendinopathy
    Keywords
    tendinopathy, elbow

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Shoulder and scapular strengthening group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Elbow focused rehabilitation
    Intervention Description
    Patient education Activity modification 2 days/week, 8 weeks in total Exercises for the wrist extensor tendon, especially the extensor carpi radialis brevis (EKRB) (stretching + strengthening)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Scapular and rotator cuff muscles strengthening
    Intervention Description
    Patient education Activity modification 2 days/week, 8 weeks in total Exercises for the wrist extensor tendon, especially the extensor carpi radialis brevis (EKRB) (stretching + strengthening) Scapular stabilizer muscle + rotator cuff (RM) strengthening
    Primary Outcome Measure Information:
    Title
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    Description
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Time Frame
    Baseline
    Title
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    Description
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Time Frame
    8th week
    Title
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    Description
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Time Frame
    16th week
    Title
    Patient-Rated Tennis Elbow Evaluation (PRTEE)
    Description
    The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
    Time Frame
    6th month
    Title
    Numeric Pain Rating Scale (NPRS)
    Description
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Time Frame
    Baseline
    Title
    Numeric Pain Rating Scale (NPRS)
    Description
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Time Frame
    8th week
    Title
    Numeric Pain Rating Scale (NPRS)
    Description
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Time Frame
    16th week
    Title
    Numeric Pain Rating Scale (NPRS)
    Description
    The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
    Time Frame
    6th month
    Secondary Outcome Measure Information:
    Title
    Pain Pressure Threshold (PPT)
    Description
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Time Frame
    Baseline
    Title
    Pain Pressure Threshold (PPT)
    Description
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Time Frame
    8th week
    Title
    Pain Pressure Threshold (PPT)
    Description
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Time Frame
    16th week
    Title
    Pain Pressure Threshold (PPT)
    Description
    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
    Time Frame
    6th month
    Title
    Hand Grip Strength
    Description
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    Baseline
    Title
    Hand Grip Strength
    Description
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    8th week
    Title
    Hand Grip Strength
    Description
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    16th week
    Title
    Hand Grip Strength
    Description
    Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    6th month
    Title
    Pain-free Hand Grip Strength
    Description
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    Baseline
    Title
    Pain-free Hand Grip Strength
    Description
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    8th week
    Title
    Pain-free Hand Grip Strength
    Description
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    16th week
    Title
    Pain-free Hand Grip Strength
    Description
    Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
    Time Frame
    6th month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cases are between the ages of 18-65 Getting a diagnosis of unilateral lateral elbow tendinopathy At least two positive Thomsen, Maudsley's Mill's and Cozen tests on clinical examination Continuing symptoms for at least 3 months The absence of any chronic disease that would prevent participation in the treatment program Exclusion Criteria: History of trauma or surgery in the involved elbow joint Having orthopedic problems in the cervical spine, shoulder joint or wrist To have participated in the rehabilitation program in the last 3 months Corticosteroid injection application in the last 3 months Systemic arthritis

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Upper Extremity-based Exercises and Elbow-focused Exercises in LET

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