The Effects of Radial and Focused Extracorporeal Shock Wa... | NCT04838002

Studies
The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis

NCT04838002

Sponsor

Şeyhmus KAPLAN

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Lateral Epicondylitis
Pain

Interventions

Extracorporeal shock wave

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2019Actual

Primary Completion Date

Apr 10, 2020Actual

Completion Date

Apr 10, 2020Actual

First Submitted Date

Apr 6, 2021

First Submission Date that Met QC Criteria

Apr 7, 2021

First Posted Date

Apr 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Extracorporeal shock wave	Device	Focus and Radial types Extracorporeal shock wave therapy	Focus ESWT Radial ESWT Sham ESWT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Şeyhmus Kaplan	Yuzuncu Yil University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuzuncu Yil University		Van			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013716	Tennis Elbow
D010146	Pain

Ancestor Terms

ID	Term
D000070639	Elbow Tendinopathy
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074059	Extracorporeal Shockwave Therapy

Ancestor Terms

ID	Term
D014464	Ultrasonic Therapy
D003972	Diathermy
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided