NCT03763513

Brief Summary

The aim of this study was to investigate the acute effect of CT application in combination with ESWT and ESWT on pain and grip strength in athletes/patients with lateral epicondylitis.It is planned that at least 30 athletes aged 18-40 who are at the Ministry of Youth and Sports, Ministry of Health, Ministry of Health Affairs and who have been diagnosed with LE by specialist doctor. After taking the information about birth dates, height, weight and dominant sides of the athletes who are willing to participate in the study, pain intensities and hand grip strengths will be evaluated. Then the athletes will be randomly divided into 2 groups according to closed envelope method. First group ESWT application; 4 sessions will be held for 4 weeks. The second group included ESWT + CT; 4 sessions will be held for 4 weeks. Pain severity and hand grip strength will be evaluated again after treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable pain

Status
unknown

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

November 29, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

November 29, 2018

Last Update Submit

December 3, 2018

Conditions

Keywords

Tennis ElbowTapingGrip StrengthPain

Outcome Measures

Primary Outcomes (2)

  • Pain Level: visual analog scale

    The pain level will evaluate By visual analog scale;min:0=no pain, maximum 10=irresistible pain

    4 weeks

  • Muscle Strength

    The muscle strength will evaluate by hand grip strength by dynamometer, is evaluating by mmHg bigger means stronger

    4 weeks

Secondary Outcomes (1)

  • Disability Level/Functionality

    4 weeks

Study Arms (2)

ESWT

ACTIVE COMPARATOR

the first group:The group that will receive Extra corporeal shock wave therapy

Device: ESWT

ESWT+KT

EXPERIMENTAL

the second group:The group that will receive Extra corporeal shock wave therapy + Kinesiotaping application

Device: ESWTOther: Kinesiotaping Application

Interventions

ESWTDEVICE

Extracorporeal Shock Wave Therapy=ESWT

ESWTESWT+KT

Kinesiotaping=KT (CT)

ESWT+KT

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Lateral Epicondylitis Disease
  • has been doing professional sports for at least three years

You may not qualify if:

  • Having systemic problems,
  • Having health problems,
  • Has undergone any surgical operation in the upper extremity
  • Has suffered upper extremity injury in the last three months
  • Neurological and orthopedic problems of the upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainTennis Elbow

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsElbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reserach Assistant. PhD. PT. Bihter Akınoğlu

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 4, 2018

Study Start

January 1, 2019

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

December 5, 2018

Record last verified: 2018-12