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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991560
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
GulOznur KARABICAK, Hacettepe University

Tracking Information
First Submitted Date  ICMJE December 9, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
DASH [ Time Frame: 30 days ]
The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as "without any difficulty"
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Grip strength [ Time Frame: 30 days ]
    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 [ Time Frame: 30days ]
    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 [ Time Frame: 30days ]
    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 [ Time Frame: 30 days ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Various Taping Techniques in Lateral Epicondylitis on Functional and Ultrasonographic Outcomes
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tennis Elbow
Intervention  ICMJE
  • Other: Strengthening exercises
    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.
  • Other: Intensive Physioytherapy
    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.
  • Device: Kinesio taping
    Kinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis
    Other Name: KT
  • Device: Athletic taping
    By athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles
    Other Name: AT
Study Arms  ICMJE
  • Experimental: Kinesio tape (KT)
    The KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques
    Interventions:
    • Other: Strengthening exercises
    • Other: Intensive Physioytherapy
    • Device: Kinesio taping
  • Experimental: Athletic taping (AT)
    An athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands).
    Interventions:
    • Other: Strengthening exercises
    • Other: Intensive Physioytherapy
    • Device: Athletic taping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2016)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02991560
Other Study ID Numbers  ICMJE HEK 10/83
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GulOznur KARABICAK, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nilgun Bek, Proffessor Hacettepe University
PRS Account Hacettepe University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP