NCT03074500

Brief Summary

The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

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

First Submitted

Initial submission to the registry

March 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 10, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

March 1, 2017

Results QC Date

May 2, 2018

Last Update Submit

October 1, 2019

Conditions

Keywords

Kinesio tapinglateral epicondylitistennis elbowtreatment

Outcome Measures

Primary Outcomes (1)

  • Patient Rated Tennis Elbow Evaluation (PRTEE)

    PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale \[5 items\] (0 = no pain, 10 = worst imaginable) 2) Function subscale \[Specific activities - 6 items, Usual activities - 4 items\] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).

    0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)

Secondary Outcomes (6)

  • The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)

    0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)

  • Visual Analogue Scale (VAS) at Rest

    0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)

  • Visual Analogue Scale (VAS) at Daily Activity

    0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)

  • Visual Analogue Scale (VAS) at Night

    0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)

  • Painless Grip Strength

    0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)

  • +1 more secondary outcomes

Study Arms (3)

Kinesiotaping

EXPERIMENTAL

Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises

Device: KinesiotapingOther: Exercise

Sham taping

SHAM COMPARATOR

Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises

Other: Sham tapingOther: Exercise

Control

OTHER

Stretching and strengthening exercises of wrist

Other: Exercise

Interventions

Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis

Kinesiotaping

Sham taping will be performed without using any technique

Sham taping

Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .

ControlKinesiotapingSham taping

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having had symptoms less than 12 weeks
  • Tenderness and pain over lateral epicondylitis
  • Provocation of the lateral elbow pain with at least one of the following tests - resisted middle finger extension (Maudley's test), resisted wrist extension or passive stretch of wrist extensors (Mill's test).

You may not qualify if:

  • Cervical spondylosis or radiculopathy
  • Diabetes mellitus
  • Neuropathy
  • Arthritis in the upper extremities
  • History of injection and physical therapy for lateral epicondylitis within the last three months
  • Pregnancy
  • History of surgery or acute trauma in the elbow
  • Allergy to tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (8)

  • Wegener RL, Brown T, O'Brien L. A randomized controlled trial of comparative effectiveness of elastic therapeutic tape, sham tape or eccentric exercises alone for lateral elbow tendinosis. Hand Therapy 2016;21(4):131-9.

    BACKGROUND
  • Kase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.

    BACKGROUND
  • Lee SS, Kang S, Park NK, Lee CW, Song HS, Sohn MK, Cho KH, Kim JH. Effectiveness of initial extracorporeal shock wave therapy on the newly diagnosed lateral or medial epicondylitis. Ann Rehabil Med. 2012 Oct;36(5):681-7. doi: 10.5535/arm.2012.36.5.681. Epub 2012 Oct 31.

  • Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.

  • Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.

  • Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.

  • Altan L, Kanat E. Conservative treatment of lateral epicondylitis: comparison of two different orthotic devices. Clin Rheumatol. 2008 Aug;27(8):1015-9. doi: 10.1007/s10067-008-0862-8. Epub 2008 Mar 26.

  • Dilek B, Batmaz I, Sariyildiz MA, Sahin E, Ilter L, Gulbahar S, Cevik R, Nas K. Kinesio taping in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):853-858. doi: 10.3233/BMR-160701.

MeSH Terms

Conditions

Tennis Elbow

Interventions

Exercise

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The limitations of this study are small sample size and relatively short follow-up time. Also, only patients with symptom duration less than 12 weeks were included so results of the study can not be generalized for chronic lateral epicondylitis.

Results Point of Contact

Title
Gulseren Derya Akyuz
Organization
Marmara University School of Medicine

Study Officials

  • Gulseren Derya Akyuz, MD,Prof

    Marmara University School of Medicine, PM&R Department

    STUDY DIRECTOR
  • Esra Giray

    Marmara University School of Medicine, PM&R Department

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To ensure group concealment, randomization will be done by using opaque, sealed envelopes which the assessors will be blinded to
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 8, 2017

Study Start

March 10, 2017

Primary Completion

April 1, 2018

Study Completion

April 30, 2018

Last Updated

October 3, 2019

Results First Posted

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations