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

November 7, 2024 updated by: Pelin Tiryaki, Istanbul University - Cerrahpasa (IUC)

Comparison of the Effectiveness of Upper Extremity-based Exercises and Elbow-focused Exercises in Lateral Elbow TendiNopathy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • İstanbul University Cerrahpaşa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Behavioral: Elbow focused rehabilitation
  • 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)
Experimental: Shoulder and scapular strengthening group
Behavioral: Scapular and rotator cuff muscles strengthening
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: Baseline
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Baseline
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 8th week
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
8th week
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 16th week
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
16th week
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: 6th month
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
6th month
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline
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.
Baseline
Numeric Pain Rating Scale (NPRS)
Time Frame: 8th week
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.
8th week
Numeric Pain Rating Scale (NPRS)
Time Frame: 16th week
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.
16th week
Numeric Pain Rating Scale (NPRS)
Time Frame: 6th month
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.
6th month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Pressure Threshold (PPT)
Time Frame: Baseline
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
Baseline
Pain Pressure Threshold (PPT)
Time Frame: 8th week
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
8th week
Pain Pressure Threshold (PPT)
Time Frame: 16th week
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
16th week
Pain Pressure Threshold (PPT)
Time Frame: 6th month
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
6th month
Hand Grip Strength
Time Frame: Baseline
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.
Baseline
Hand Grip Strength
Time Frame: 8th week
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.
8th week
Hand Grip Strength
Time Frame: 16th week
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.
16th week
Hand Grip Strength
Time Frame: 6th month
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.
6th month
Pain-free Hand Grip Strength
Time Frame: Baseline
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.
Baseline
Pain-free Hand Grip Strength
Time Frame: 8th week
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.
8th week
Pain-free Hand Grip Strength
Time Frame: 16th week
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.
16th week
Pain-free Hand Grip Strength
Time Frame: 6th month
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.
6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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