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Clinical Trials/NCT03074500
NCT03074500CompletedNot Applicable

A Randomized Controlled Trial Comparing the Effects of Kinesiology Taping With Exercise, Sham Taping With Exercise and Exercise Alone for Lateral Epicondylitis

Marmara University1 site in 1 country30 target enrollmentStarted: March 10, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Patient Rated Tennis Elbow Evaluation (PRTEE)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

To ensure group concealment, randomization will be done by using opaque, sealed envelopes which the assessors will be blinded to

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Arthritis in the upper extremities
  • •History of injection and physical therapy for lateral epicondylitis within the last three months
  • •History of surgery or acute trauma in the elbow
  • •Allergy to tape

Arms & Interventions

Sham taping

Sham Comparator

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

Intervention: Sham taping (Other)

Sham taping

Sham Comparator

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

Intervention: Exercise (Other)

Control

Other

Stretching and strengthening exercises of wrist

Intervention: Exercise (Other)

Kinesiotaping

Experimental

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

Intervention: Kinesiotaping (Device)

Kinesiotaping

Experimental

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

Intervention: Exercise (Other)

Outcomes

Primary Outcomes

Patient Rated Tennis Elbow Evaluation (PRTEE)

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

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 Outcomes

  • 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))
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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