Lateral Epicondylitis Clinical Trial
Official title:
A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis
Verified date | October 2019 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Having had symptoms less than 12 weeks 2. Tenderness and pain over lateral epicondylitis 3. 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: 1. Cervical spondylosis or radiculopathy 2. Diabetes mellitus 3. Neuropathy 4. Arthritis in the upper extremities 5. History of injection and physical therapy for lateral epicondylitis within the last three months 6. Pregnancy 7. History of surgery or acute trauma in the elbow 8. Allergy to tape |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University School of Medicine Department of Physical Medicine and Rehabilitation | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View 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. — View 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 Stud — View Citation
Kase K. Clinical therapeutic applications of the Kinesio taping methods. 2016.
Küçüksen 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: 10.10 — View 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. Ep — View 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. Review. — View 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment) | |
Secondary | 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. | 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) | |
Secondary | 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. | 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) | |
Secondary | 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. | 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment) | |
Secondary | 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. | 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) | |
Secondary | 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. | 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) |
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