<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02991560</url>
  </required_header>
  <id_info>
    <org_study_id>HEK 10/83</org_study_id>
    <nct_id>NCT02991560</nct_id>
  </id_info>
  <brief_title>Effects of Various Taping Techniques in Lateral Epicondylitis on Functional and Ultrasonographic Outcomes</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the early effects of the application of elastic (Kinesio Tape®) and non-elastic&#xD;
      (Athletic Tape) taping as part of the conventional physiotherapy of the lateral epicondylitis&#xD;
      using the results from ultrasonography and clinical tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis (LE), also known as tennis elbow, is an overuse injury causing elbow&#xD;
      pain, and it is difficult to treat. It is characterized with frequent pain and sensitivity at&#xD;
      the lateral section of the elbow, mostly at the extensor tendon (extensor carpi radialis&#xD;
      brevis [ECRB]) origin and the extensor digitorum communis [EDC] muscle. It was estimated that&#xD;
      annually it occurs in about 1%-3% of adult individuals worldwide. There is no consensus&#xD;
      regarding its etiology; however, it has been associated with repetitive movements, smoking,&#xD;
      and factors increasing physical load, such as obesity. In recent studies, workplace use of&#xD;
      non-naturally positioned elbow and wrist have been associated with elbow pain. In addition,&#xD;
      repetitive microtraumas have been known to be triggering injuries.&#xD;
&#xD;
      Pain is the primary complaint in LE patients. Pain increases with activity, and it becomes&#xD;
      acute with injury or trauma. LE is associated with decreased extensor muscle strength and&#xD;
      variations in biomechanics; however, it has been a matter of debate whether these variations&#xD;
      are the cause or the result of LE. In its pathophysiology, three interacting components,&#xD;
      namely local tendon pathology, changes in the pain system, and losses in motor function have&#xD;
      been reported. Recent studies have highlighted that, rather than an inflammatory condition,&#xD;
      tendinosis (chronic symptomatic degeneration of tendon) occurs in the forearm common extensor&#xD;
      muscle tendon adhering to the lateral epicondyle of the humerus. Ultrasound evaluations&#xD;
      indicate various tendon pathologies, such as tendon thickening, focused hypoechogenic zones,&#xD;
      tendon lacerations, and calcification.&#xD;
&#xD;
      LE may heal on its own and usually responds to conservative treatment. In case conservative&#xD;
      treatment is inconclusive, surgical methods may be opted for. Several conservative methods&#xD;
      are among the treatment options for LE, such as resting, nonsteroidal anti-inflammatory drugs&#xD;
      (NSAID), injection treatments, exercises, and physiotherapy programs involving manual therapy&#xD;
      techniques, massage, braces, deep friction message, extracorporeal shockwave, low level laser&#xD;
      therapy, low frequency electrical stimulation, and other electrophysiological agents. The use&#xD;
      of non-elastic taping techniques is an approach utilized in the conservative treatment of LE&#xD;
      and there exist reports examining its instantaneous effects on muscle strength, grip&#xD;
      strength, and pain; however, it was indicated that further studies are warranted to show the&#xD;
      effectiveness of taping. Kinesio Taping®, which involves elastic tapes, is rather a more&#xD;
      recent technique used in orthopedic injuries in addition to physiotherapy, and it has been&#xD;
      gaining popularity. Even though there are reports indicating the effects of adhesive tape on&#xD;
      muscle and grip strength in LE patients, its effectiveness could not be compared with other&#xD;
      treatment modalities because of several reasons, such as its instantaneous effects or the&#xD;
      lack of a control group.&#xD;
&#xD;
      The literature review shows that, due to the structural differences between athletic tape and&#xD;
      Kinesio Tape®, athletic taping applications are rather adopted to control the movement of the&#xD;
      joint with pain, to support non-contractile structures, such as ligament and capsule, and for&#xD;
      stability. Studies utilizing non-elastic tapes in the treatment of LE are inadequate because&#xD;
      they examine effects in the acute period and they lack comparisons. On the other hand, it has&#xD;
      been observed that Kinesio Tape® is mostly used for functional support, muscular&#xD;
      facilitation, and myofascial relaxation, and studies focusing on the management of lateral&#xD;
      epicondylitis are scarce.&#xD;
&#xD;
      The aim of the present study is, in LE patients, to compare the short-term effects of two&#xD;
      different taping techniques in addition to an intense physiotherapy program on the severity&#xD;
      of pain, grip strength, functional status, joint limitations, and structural changes in&#xD;
      tendons that can be indicated by diagnostic USG&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DASH</measure>
    <time_frame>30 days</time_frame>
    <description>The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as &quot;without any difficulty&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>30 days</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>USG examinations</measure>
    <time_frame>30days</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>30days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>30 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Kinesio tape (KT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Athletic taping (AT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strengthening exercises</intervention_name>
    <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.</description>
    <arm_group_label>Athletic taping (AT)</arm_group_label>
    <arm_group_label>Kinesio tape (KT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensive Physioytherapy</intervention_name>
    <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.</description>
    <arm_group_label>Athletic taping (AT)</arm_group_label>
    <arm_group_label>Kinesio tape (KT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesio taping</intervention_name>
    <description>Kinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis</description>
    <arm_group_label>Kinesio tape (KT)</arm_group_label>
    <other_name>KT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Athletic taping</intervention_name>
    <description>By athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles</description>
    <arm_group_label>Athletic taping (AT)</arm_group_label>
    <other_name>AT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        pain over the lateral epicondyle, pain during grip strength testing, pain in one of the&#xD;
        following tests: extensor carpi radialis test&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inflammatory, autoimmune, endocrine, or kidney diseases, cubital tunnel syndrome,&#xD;
             carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional&#xD;
             shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or&#xD;
             traumas, allergies to the adhesive tape, and those who received corticosteroid&#xD;
             injection and used any oral anti-inflammatory medicine due to lateral epicondylitis&#xD;
             within the previous month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilgun Bek, Proffessor</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>GulOznur KARABICAK</investigator_full_name>
    <investigator_title>Phd PT</investigator_title>
  </responsible_party>
  <keyword>physiotherapy</keyword>
  <keyword>taping</keyword>
  <keyword>conservative treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991560
org study id: HEK 10/83
nct id: NCT02991560
lead sponsor: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: DASH
time frame: 30 days
description: The patients were asked to grade the activities involving shoulder, arm, and hand motions within the previous week as "without any difficulty"
measure: Grip strength
time frame: 30 days
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
measure: USG examinations
time frame: 30days
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
measure: Muscle strength
time frame: 30days
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.
measure: Pain intensity
time frame: 30 days
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.
arm group label: Kinesio tape (KT)
arm group type: Experimental
description: The KT group was taped 2 days a week for 4 weeks using the muscle and fascia correction techniques
arm group label: Athletic taping (AT)
arm group type: Experimental
description: An athletic tape with adhesive backing was used (38 mm wide-Muller Protape-The Netherlands).
intervention type: Other
intervention name: Strengthening exercises
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.
arm group label: Athletic taping (AT)
arm group label: Kinesio tape (KT)
intervention type: Other
intervention name: Intensive Physioytherapy
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.
arm group label: Athletic taping (AT)
arm group label: Kinesio tape (KT)
intervention type: Device
intervention name: Kinesio taping
description: Kinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis
arm group label: Kinesio tape (KT)
other name: KT
intervention type: Device
intervention name: Athletic taping
description: By athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles
arm group label: Athletic taping (AT)
other name: AT
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: No
last name: Nilgun Bek, Proffessor
role: Study Director
affiliation: Hacettepe University
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: GulOznur KARABICAK
investigator title: Phd PT
mesh term: Tennis Elbow
sharing ipd: No