NCT02930304

Brief Summary

Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. The aim of this study is to The compare the short-term effects of different physiotherapy approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

October 2, 2016

Last Update Submit

April 11, 2018

Conditions

Tennis Elbow

Keywords

tennis elbowpainshock wavekinesio taping

Outcome Measures

Primary Outcomes (1)

  • pain assessment

    pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline and at the end of the three week treatment sessions

    from baseline to third week after treatment sessions

Secondary Outcomes (2)

  • functional assessment

    from baseline to third week after treatment sessions

  • maximum grip strength evaluation

    from baseline to third week after treatment sessions

Study Arms (3)

first physiotherapy

EXPERIMENTAL

cold pack, TENS, exercise

Other: first physiotherapy

second physiotherapy

EXPERIMENTAL

cold pack, TENS, exercise, kinesiotaping

Other: second physiotherapy

third physiotherapy

EXPERIMENTAL

cold pack, TENS, ESWT, exercise

Other: third physiotherapy

Interventions

first physiotherapyOTHER

physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions

Also known as: physiotherapy
first physiotherapy
second physiotherapyOTHER

physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy

Also known as: kinesiotaping
second physiotherapy
third physiotherapyOTHER

physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session.

Also known as: Extracorporeal shockwave therapy (ESWT)
third physiotherapy

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with tennis elbow,
  • and the duration of symptoms was between 8 and 10 weeks,
  • and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors.
  • Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study

You may not qualify if:

  • patients with inflammatory, autoimmune, endocrine or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas,
  • allergies to adhesive tape,
  • and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis ElbowPain

Interventions

Physical Therapy ModalitiesExtracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationUltrasonic TherapyDiathermyHyperthermia, Induced

Study Design

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

Study Record Dates

First Submitted

October 2, 2016

First Posted

October 12, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)