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Effects of Various Taping Techniques in Lateral Epicondylitis on Functional and Ultrasonographic Outcomes

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Strengthening exercises
Intensive Physioytherapy
Kinesio taping
Athletic taping
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring physiotherapy, taping, conservative treatment

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

pain over the lateral epicondyle, pain during grip strength testing, pain in one of the following tests: extensor carpi radialis test

-

Exclusion Criteria:

  • 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 the adhesive tape, and those who received corticosteroid injection and used any oral anti-inflammatory medicine due to lateral epicondylitis within the previous month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Kinesio tape (KT)

    Athletic taping (AT)

    Arm Description

    The KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques

    An athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands).

    Outcomes

    Primary Outcome Measures

    DASH
    The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as "without any difficulty"

    Secondary Outcome Measures

    Grip strength
    Grip strength was measured using a Jamar hand dynamometer in kilograms. The measurement was performed 3 times and the mean value was used for evaluation. The patients were seated on an armless chair with 90° flexion of hip and knee. The patients grasped the dynamometer for a maximum of 3 seconds while their shoulders were in adduction-neutral rotation, their wrists were in flexion, and the forearms were in semipronation to provide a stronger grip
    USG examinations
    USG examinations were performed in real-time using a GE Logiq 7 ultrasound scanner (General Electric Medical Systems, USA) with a linear 12 MHz (10-14 MHz) probe. A standard technique, as outlined by the European Society of Musculoskeletal Skeletal Radiology ultrasound subcommittee32, was employed for all tests
    Muscle strength
    Muscle strength of the wrist flexion and extension was evaluated using the Biodex Multi-joint Isokinetic System 3 Pro. Measurements were performed at two different speeds: 60°/sec and 120°/sec.
    Pain intensity
    Pain intensity was evaluated using the visual analog score (VAS) at night and rest-activity. The patients assigned a value for their pain between 0 and 10 on the VAS scale. In this scale, the absence of pain was marked as 0 while the most severe unbearable pain was expressed as 10.

    Full Information

    First Posted
    December 9, 2016
    Last Updated
    December 12, 2016
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02991560
    Brief Title
    Effects of Various Taping Techniques in Lateral Epicondylitis on Functional and Ultrasonographic Outcomes
    Official Title
    Effects of Various Taping Techniques in Lateral Epicondylitis Administered in Addition to an Intensive Physiotherapy Program on Functional and Ultrasonographic Outcomes: a Double-blind, Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis using the results from ultrasonography and clinical tests.
    Detailed Description
    Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury causing elbow pain, and it is difficult to treat. It is characterized with frequent pain and sensitivity at the lateral section of the elbow, mostly at the extensor tendon (extensor carpi radialis brevis [ECRB]) origin and the extensor digitorum communis [EDC] muscle. It was estimated that annually it occurs in about 1%-3% of adult individuals worldwide. There is no consensus regarding its etiology; however, it has been associated with repetitive movements, smoking, and factors increasing physical load, such as obesity. In recent studies, workplace use of non-naturally positioned elbow and wrist have been associated with elbow pain. In addition, repetitive microtraumas have been known to be triggering injuries. Pain is the primary complaint in LE patients. Pain increases with activity, and it becomes acute with injury or trauma. LE is associated with decreased extensor muscle strength and variations in biomechanics; however, it has been a matter of debate whether these variations are the cause or the result of LE. In its pathophysiology, three interacting components, namely local tendon pathology, changes in the pain system, and losses in motor function have been reported. Recent studies have highlighted that, rather than an inflammatory condition, tendinosis (chronic symptomatic degeneration of tendon) occurs in the forearm common extensor muscle tendon adhering to the lateral epicondyle of the humerus. Ultrasound evaluations indicate various tendon pathologies, such as tendon thickening, focused hypoechogenic zones, tendon lacerations, and calcification. LE may heal on its own and usually responds to conservative treatment. In case conservative treatment is inconclusive, surgical methods may be opted for. Several conservative methods are among the treatment options for LE, such as resting, nonsteroidal anti-inflammatory drugs (NSAID), injection treatments, exercises, and physiotherapy programs involving manual therapy techniques, massage, braces, deep friction message, extracorporeal shockwave, low level laser therapy, low frequency electrical stimulation, and other electrophysiological agents. The use of non-elastic taping techniques is an approach utilized in the conservative treatment of LE and there exist reports examining its instantaneous effects on muscle strength, grip strength, and pain; however, it was indicated that further studies are warranted to show the effectiveness of taping. Kinesio Taping®, which involves elastic tapes, is rather a more recent technique used in orthopedic injuries in addition to physiotherapy, and it has been gaining popularity. Even though there are reports indicating the effects of adhesive tape on muscle and grip strength in LE patients, its effectiveness could not be compared with other treatment modalities because of several reasons, such as its instantaneous effects or the lack of a control group. The literature review shows that, due to the structural differences between athletic tape and Kinesio Tape®, athletic taping applications are rather adopted to control the movement of the joint with pain, to support non-contractile structures, such as ligament and capsule, and for stability. Studies utilizing non-elastic tapes in the treatment of LE are inadequate because they examine effects in the acute period and they lack comparisons. On the other hand, it has been observed that Kinesio Tape® is mostly used for functional support, muscular facilitation, and myofascial relaxation, and studies focusing on the management of lateral epicondylitis are scarce. The aim of the present study is, in LE patients, to compare the short-term effects of two different taping techniques in addition to an intense physiotherapy program on the severity of pain, grip strength, functional status, joint limitations, and structural changes in tendons that can be indicated by diagnostic USG

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tennis Elbow
    Keywords
    physiotherapy, taping, conservative treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesio tape (KT)
    Arm Type
    Experimental
    Arm Description
    The KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques
    Arm Title
    Athletic taping (AT)
    Arm Type
    Experimental
    Arm Description
    An athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands).
    Intervention Type
    Other
    Intervention Name(s)
    Strengthening exercises
    Intervention Description
    The exercises consisted of 3 sets with 20 repetitions of wrist and elbow flexion; 2 sets with 10 repetitions of wrist extension strengthening starting with 50% of the maximum strength and density increasing the resistance each week; and finally, 2 sets with 10 repetitions of the wrist flexor and extensor muscle groups comprising 20 sec of stretching and 10 sec of relaxing using the healthy hand.
    Intervention Type
    Other
    Intervention Name(s)
    Intensive Physioytherapy
    Intervention Description
    The treatment consisted of a cold pack (enclosed in a moist towel for 12 minutes around the elbow joint), TENS (in an asymmetrical biphasic wave form and burst modulation, current width 150 mms, pulse frequency 5 Hz), and deep transverse friction massage (2 minutes of application to the locally sensitive areas determined through palpation on anterolateral surface of lateral epicondyle) followed by home exercises.
    Intervention Type
    Device
    Intervention Name(s)
    Kinesio taping
    Other Intervention Name(s)
    KT
    Intervention Description
    Kinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis
    Intervention Type
    Device
    Intervention Name(s)
    Athletic taping
    Other Intervention Name(s)
    AT
    Intervention Description
    By athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles
    Primary Outcome Measure Information:
    Title
    DASH
    Description
    The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as "without any difficulty"
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Grip strength
    Description
    Grip strength was measured using a Jamar hand dynamometer in kilograms. The measurement was performed 3 times and the mean value was used for evaluation. The patients were seated on an armless chair with 90° flexion of hip and knee. The patients grasped the dynamometer for a maximum of 3 seconds while their shoulders were in adduction-neutral rotation, their wrists were in flexion, and the forearms were in semipronation to provide a stronger grip
    Time Frame
    30 days
    Title
    USG examinations
    Description
    USG examinations were performed in real-time using a GE Logiq 7 ultrasound scanner (General Electric Medical Systems, USA) with a linear 12 MHz (10-14 MHz) probe. A standard technique, as outlined by the European Society of Musculoskeletal Skeletal Radiology ultrasound subcommittee32, was employed for all tests
    Time Frame
    30days
    Title
    Muscle strength
    Description
    Muscle strength of the wrist flexion and extension was evaluated using the Biodex Multi-joint Isokinetic System 3 Pro. Measurements were performed at two different speeds: 60°/sec and 120°/sec.
    Time Frame
    30days
    Title
    Pain intensity
    Description
    Pain intensity was evaluated using the visual analog score (VAS) at night and rest-activity. The patients assigned a value for their pain between 0 and 10 on the VAS scale. In this scale, the absence of pain was marked as 0 while the most severe unbearable pain was expressed as 10.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pain over the lateral epicondyle, pain during grip strength testing, pain in one of the following tests: extensor carpi radialis test - Exclusion Criteria: 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 the adhesive tape, and those who received corticosteroid injection and used any oral anti-inflammatory medicine due to lateral epicondylitis within the previous month
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nilgun Bek, Proffessor
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Various Taping Techniques in Lateral Epicondylitis on Functional and Ultrasonographic Outcomes

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