NCT05809622

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 6, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

June 6, 2022

Last Update Submit

November 7, 2024

Conditions

Keywords

tendinopathyelbow

Outcome Measures

Primary Outcomes (8)

  • 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.

    Baseline

  • 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.

    8th week

  • 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.

    16th week

  • 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.

    6th month

  • 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.

    Baseline

  • 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.

    8th week

  • 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.

    16th week

  • 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.

    6th month

Secondary Outcomes (12)

  • Pain Pressure Threshold (PPT)

    Baseline

  • Pain Pressure Threshold (PPT)

    8th week

  • Pain Pressure Threshold (PPT)

    16th week

  • Pain Pressure Threshold (PPT)

    6th month

  • Hand Grip Strength

    Baseline

  • +7 more secondary outcomes

Study Arms (2)

Shoulder and scapular strengthening group

EXPERIMENTAL
Behavioral: Scapular and rotator cuff muscles strengthening

Control group

ACTIVE COMPARATOR
Behavioral: Elbow focused rehabilitation

Interventions

* 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)

Control group

* 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

Shoulder and scapular strengthening group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis ElbowElbow TendinopathyTendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, MSc

Study Record Dates

First Submitted

June 6, 2022

First Posted

April 12, 2023

Study Start

April 10, 2023

Primary Completion

December 30, 2024

Study Completion

June 1, 2025

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations