NCT07282431

Brief Summary

The primary objective of this study is to compare the clinical effectiveness of exercise therapy alone versus exercise combined with Extracorporeal Shock Wave Therapy (ESWT) in individuals with lateral epicondylitis, focusing on changes in pain, grip strength, functional status, and overall treatment success.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

June 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 16, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

Lateral epicondylitis Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (2)

  • Extracorporeal Shock Wave Therapy (ESWT) applied in addition to exercise does not create a significant difference in pain level, grip strength and functional status in individuals with lateral epicondylitis compared to exercise alone.

    Pain Intensity (Visual Analog Scale - VAS) Description: Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level on the line. Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse pain.

    8 week

  • Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH)

    Upper Extremity Function (Quick Disabilities of the Arm, Shoulder and Hand Questionnaire - QuickDASH) Description: Functional status will be measured using the QuickDASH questionnaire. Scores range from 0 (no disability) to 100 (severe disability). Time Frame: Baseline and 8 weeks Outcome Type: Continuous Interpretation: Higher scores indicate worse functional impairment.

    8 week

Study Arms (2)

Control Group

EXPERIMENTAL

Participants will be randomly assigned to two groups; one group will receive exercise therapy alone,

Other: exercise therapy

Extracorporeal Shock Wave Therapy (ESWT)

EXPERIMENTAL

Participants will be randomly assigned to two groups; one group will receive exercise therapy alone, while the other group will receive exercise plus Extracorporeal Shock Wave Therapy (ESWT). Clinical efficacy will be assessed by pre- and post-treatment measurements.

Other: Extracorporeal Shock Wave Therapy (ESWT)

Interventions

Extracorporeal Shock Wave Therapy (ESWT)

Extracorporeal Shock Wave Therapy (ESWT)

exercise therapy

Control Group

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older
  • Having a clinical diagnosis of lateral epicondylitis
  • Not having received any other similar treatment within the last 6 months
  • Having the cognitive ability to understand the Turkish questionnaire and assessment forms
  • Voluntarily agreeing to participate in the study and providing written informed consent

You may not qualify if:

  • Having a history of concomitant systemic, rheumatological, or inflammatory diseases that could affect pain
  • Having a history of trauma, surgery, or neurological disease in the upper extremity
  • Presence of conditions other than lateral epicondylitis, such as tendinopathy, bursitis, or nerve entrapment
  • Having major psychiatric disorders that could affect the pain threshold (e.g., major depression, schizophrenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul medipol University

Istanbul, Beykoz, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave TherapyExercise Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Salih tan, doctorate

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorate

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 15, 2025

Study Start

June 15, 2025

Primary Completion

January 15, 2026

Study Completion

February 15, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations