NCT04838002

Brief Summary

To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

April 6, 2021

Last Update Submit

April 7, 2021

Conditions

Lateral EpicondylitisPain

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    pain evaluation, higher scores mean a worse outcome.

    1 min.

  • Patient-Rated Tennis Elbow Evaluation

    Scale, Higher scores represent higher level of pain and disability.

    5 min.

Study Arms (3)

Focus ESWT

ACTIVE COMPARATOR
Device: Extracorporeal shock wave

Radial ESWT

ACTIVE COMPARATOR
Device: Extracorporeal shock wave

Sham ESWT

SHAM COMPARATOR
Device: Extracorporeal shock wave

Interventions

Extracorporeal shock waveDEVICE

Focus and Radial types Extracorporeal shock wave therapy

Focus ESWTRadial ESWTSham ESWT

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of lateral epicondylitis
  • be aged ≥18 at the time of diagnosis
  • be give informed consent

You may not qualify if:

  • be have not completed the assessment process.
  • elbow deformity
  • psychological illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis ElbowPain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Şeyhmus Kaplan

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

August 7, 2019

Primary Completion

April 10, 2020

Study Completion

April 10, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)