Kinesiotaping in Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Sham taping
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Kinesio taping, lateral epicondylitis, tennis elbow, treatment
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
Kinesiotaping
Sham taping
Control
Arm Description
Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises
Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises
Stretching and strengthening exercises of wrist
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability.
Visual Analogue Scale (VAS) at Rest
Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Visual Analogue Scale (VAS) at Daily Activity
Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Visual Analogue Scale (VAS) at Night
Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Painless Grip Strength
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded.
Grip Strength
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03074500
Brief Title
Kinesiotaping in Lateral Epicondylitis
Official Title
A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Lateral epicondylitis or tennis elbow is a often-encountered disorder of elbow which is characterized by tenderness and pain over lateral epicondylitis of humerus and grip weakness. The annual incidence of lateral epicondylitis has been reported to be %1-3 in general population. Lateral epicondylitis is commonly associated with repetitive overuse of wrist, activities including strong grip which in turn cause microtears and degenerative changes over the common origin of wrist and finger extensors on lateral epicondyle. New researches have shown that the underlying mechanism is degenerative rather than inflammatory. It has been proposed that the cause of pain may be mechanical discontinuity of collagen fibers or biochemical irritation that results from damaged tendon tissue that activates nociceptors. It has been suggested that eccentric loading has been shown to assist with tendon rehabilitation by improving collagen alignment and stimulating collagen cross-linkage formation, both of which can improve tensile strength.
Kinesio taping (KT) which is a new application of adhesive taping was designed by Kenzo Kase to avoid unwanted effects of conventional taping such as restricting range of motion (ROM) and limiting functional activities. The recommended tape application methods are outlined in 'Clinical Therapeutic Applications of the Kinesio Taping Method' 8. Elastic therapeutic tape has been designed to allow for a longitudinal stretch of up to 140% of its resting length and has been designed to approximate the elastic qualities of the human skin. In particular, the application of the tape over stretched muscle to create convolutions in the skin has been hypothesized to reduce pressure in the mechanoreceptors below the dermis, thereby decreasing nociceptive stimuli. Another mechanism which is claimed by the proponent of the tape is that convolutions are raised ridges of the tape and the skin that are thought to decompress underlying structures and allow for enhanced circulation by increased subcutaneous space. In the last few years, the use of KT has become increasingly popular in rehabilitation programs as an adjunct in the treatment. However, scientific evidence about its effect is insufficient.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Kinesio taping, lateral epicondylitis, tennis elbow, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
To ensure group concealment, randomization will be done by using opaque, sealed envelopes which the assessors will be blinded to
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinesiotaping
Arm Type
Experimental
Arm Description
Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises
Arm Title
Sham taping
Arm Type
Sham Comparator
Arm Description
Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises
Arm Title
Control
Arm Type
Other
Arm Description
Stretching and strengthening exercises of wrist
Intervention Type
Device
Intervention Name(s)
Kinesiotaping
Intervention Description
Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis
Intervention Type
Other
Intervention Name(s)
Sham taping
Intervention Description
Sham taping will be performed without using any technique
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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. .
Primary Outcome Measure Information:
Title
Patient Rated Tennis Elbow Evaluation (PRTEE)
Description
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).
Time Frame
0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Secondary Outcome Measure Information:
Title
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
Description
The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability.
Time Frame
0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Title
Visual Analogue Scale (VAS) at Rest
Description
Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Time Frame
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)
Title
Visual Analogue Scale (VAS) at Daily Activity
Description
Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Time Frame
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)
Title
Visual Analogue Scale (VAS) at Night
Description
Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Time Frame
0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
Title
Painless Grip Strength
Description
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded.
Time Frame
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)
Title
Grip Strength
Description
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulseren Derya Akyuz, MD,Prof
Organizational Affiliation
Marmara University School of Medicine, PM&R Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Esra Giray
Organizational Affiliation
Marmara University School of Medicine, PM&R Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
Kase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.
Results Reference
background
PubMed Identifier
23185733
Citation
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.
Results Reference
result
PubMed Identifier
23796685
Citation
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.
Results Reference
result
PubMed Identifier
11869609
Citation
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.
Results Reference
result
PubMed Identifier
27666156
Citation
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.
Results Reference
result
PubMed Identifier
18365136
Citation
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.
Results Reference
result
PubMed Identifier
27232082
Citation
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.
Results Reference
result
Learn more about this trial
Kinesiotaping in Lateral Epicondylitis
We'll reach out to this number within 24 hrs