<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/NCT04505215</url>
  </required_header>
  <id_info>
    <org_study_id>KaratayUS</org_study_id>
    <nct_id>NCT04505215</nct_id>
  </id_info>
  <brief_title>Comparison of Mulligan Technique and Muscle Energy Technique in Lateral Epicondylitis</brief_title>
  <official_title>Comparison of the Effect of Mulligan and Muscle Energy Techniques on Pain, Grip Strength and Functionality in Individuals With Lateral Epicondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KTO Karatay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KTO Karatay University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the effects of mulligan and muscle energy techniques on pain, grip strength&#xD;
      and functionality will be investigated in a randomized controlled manner in individuals with&#xD;
      lateral epicondylitis. Various treatments have been tried in patients with lateral&#xD;
      epicondylitis whose daily activities are restricted in order to reduce pain and increase&#xD;
      functions. Among them, conservative and physical therapy agents have an important place.&#xD;
      There are many studies in the literature evaluating the effects of mobilization in LE&#xD;
      treatment. However, there are no definitive data on the long-term efficacy and benefits of&#xD;
      all these treatment methods. Mulligan and muscle energy techniques can be used in lateral&#xD;
      epicondylitis due to many positive reasons such as being effective in a short time, giving&#xD;
      fast results, high success rate, risk-free and painless in the case of specialists. Thanks to&#xD;
      the findings obtained from our study, it is aimed to contribute to the literature with&#xD;
      objective, evidence-based results in this field.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis (LE); It is one of the most common lesions of the upper limb,&#xD;
      originating from the wrist and wrist extensor muscles, characterized by pain in the lateral&#xD;
      epicondyle and extensor muscle surface of the forearm. LE was first described by Runge in&#xD;
      1873 and was named tennis elbow by Morris in 1882. It is thought that the cause of LE is&#xD;
      caused by repetitive stresses, direct traumas, repetitive contractions, degeneration, micro&#xD;
      tears, immature repair and tendinosis at the adhesion of the extensor carpi radialis brevis&#xD;
      and extensor digitorum communis muscles. It is mostly seen in 4-6 decades. More dominant&#xD;
      upper limb is affected. Its annual incidence has been determined between 1-3%. It has been&#xD;
      shown that it can cause a significant loss of labor due to pain in patients.&#xD;
&#xD;
      The Mulligan Concept is a new approach in Manual Therapy. It was started to be developed by&#xD;
      New Zealand physiotherapist Brian Mulligan in the 1980s, and its popularity and awareness has&#xD;
      increased in the last 10 years. The concept-specific techniques called NAGS, SNAGS and MWMs&#xD;
      are applied safely and effectively in musculoskeletal-nervous system diseases. The concept is&#xD;
      suitable for biomechanics, arthrokinematic kinesiological principles, which are the common&#xD;
      knowledge of the known Manual Therapy approaches, and techniques and application principles&#xD;
      are important with other approaches. show differences.&#xD;
&#xD;
      Manual therapy and forearm extensor muscle strengthening are used together with MWM&#xD;
      (mobilization with movement) technique. MWM eliminates elbow pain by reducing abnormal&#xD;
      facilitations and creates some tactile and compressive stimuli in soft tissue. Afferent nerve&#xD;
      activity results in these tactile and compressive stimuli inhibiting spinal cord neurons.&#xD;
      Force is applied at long load at low load. Increases the harmony and mobility of connective&#xD;
      tissue layers.&#xD;
&#xD;
      Mulligan concept; It can be defined as a combination of passive mobilization concepts such as&#xD;
      Kaltenborn, Maitland Cyriax, and active methods such as Pilates, PNF and Kinetic Control. The&#xD;
      distinctive feature of this approach is that, when the right case is chosen, the pain can be&#xD;
      achieved, functional gains can be achieved in a very short time and in the long term.&#xD;
&#xD;
      Postisometric reconstruction: muscle energy technique (MET) is a manual therapy that uses&#xD;
      muscle's own energy in the form of mild isometric contractions to relax and lengthen muscles&#xD;
      through autogenic or mutual inhibition. Compared to static stretching, a passive technique in&#xD;
      which the therapist does all the work, MET is an active technique in which the patient is&#xD;
      also an active participant. BAT is based on the concepts of Autogenic Inhibition and Mutual&#xD;
      Inhibition. If a maximum contraction of the muscle is followed by the stretching of the same&#xD;
      muscle, Autogenic Inhibition is known as MET, and if the opposite muscle following a maximum&#xD;
      contraction of the muscle is stretched, it is known as Mutual Inhibition MET.&#xD;
&#xD;
      The manipulative treatment acts directly on the joint structures and creates a nociceptive&#xD;
      afferent stimulation by providing physiological effect on the central nervous system. Such&#xD;
      findings emphasize the appropriateness of the local movements of mobilization. Such a&#xD;
      mechanism may include intranoral circulation, axoplasmic flow, or neural connective tissue&#xD;
      viscoelasticity. However, an increasing number of studies have shown that passive joint&#xD;
      movements can activate many areas.&#xD;
&#xD;
      Exercise programs are the most common physiotherapy treatments for LE. There are many studies&#xD;
      examining the effects of exercise programs in LE. Stretching and strengthening exercises are&#xD;
      at the core of the exercise program. Because the tendon should not only be strengthened, it&#xD;
      should be flexible. Home exercises should usually be done once or twice a day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">November 14, 2020</completion_date>
  <primary_completion_date type="Actual">November 7, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Hand Grip Strenght at 6 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>The maximum grip force measurements of the patients were made with &quot;Baseline Hydraulic Hand Dynamometer&quot;. The patient's measurements were carried out in two positions. While the patient was in a sitting position, measurements were made in shoulder adduction, elbow 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ in ulnar deviation position. While the patient was standing, measurement was performed with shoulder adduction, elbow extension, forearm in neutral position. For maximum grip, patients should be able to hold the dynamometer for a maximum of 3 seconds. it was said to tighten with all its might. Measurements were repeated 3 times at 30-second intervals on the affected limb, and the measurements were averaged. Values are noted in kilograms (kg) - force</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Pain Score at 6 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Visual Analogue Scale was used to determine the severity of rest, activity and night pain in patients with lateral epicondylitis. Patients were asked to mark their pain levels on a 10 cm scale before starting treatment and after 4 weeks of treatment. The value &quot;0&quot; means that there is no pain, and the value &quot;10&quot; means unbearable pain. The marked points are measured and recorded in centimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Functionality at 6 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Patient-rated Forearm Evaluation Questionnaire Overend et al. It was designed to evaluate treatment specifically for patients with lateral epicondylitis. Afterwards, it was rearranged by the same working group and named as Patient-rated Forearm Evaluation Questionnaire. The survey consists of 15 questions that question patients' difficulties and pain in the past week. Pain level (5 questions), elbow-related functions (6 questions, special activities, 4 questions daily activities) are evaluated in the first section. The total score ranges from 0 to 100, and high scores indicate increased pain and loss of functionality. In 2010, Altan et al. Turkish version was created by, Patient-rated Forearm Evaluation Questionnaire was found valid and reliable. Turkish version of the questionnaire was used in our study.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Mulligan Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the exercises applied to the participants in the control group, the participants in this group used Mobilization with movement, which was performed with the principle of painless movement 3 times a week for a total of 12 times a week for 4 weeks. Mobilization with movement has been performed by a certified physiotherapist who has been practicing this technique for 10 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle Energy Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the exercises applied to the participants in the control group, the Janda method (Post Isometric Relaxation Technique) from Muscle Energy Technique (3 times a week) was used 3 times a week for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only Exercise (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stretching and strengthening exercises for the forearm extensors were shown to the participants in the control group for 4 weeks every day of the week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mulligan Technique</intervention_name>
    <description>First, the painless application angle was determined for each patient. The lateral condyle of the humerus was fixed by the web range of the physiotherapist. The elbow joint was glided until the elbow joint and the hand tightening position were not able to cause pain.&#xD;
The patients were asked to repeat the motion of the elbow joint and the ball squeezing motion given to their hands 10 times without pain. For pain control, the same procedure was performed with three sets, each containing 10 repetitions of the exercise. The interval between sets was 15 to 20 seconds, and the interval between repetitions within each set was 30 seconds.</description>
    <arm_group_label>Mulligan Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Muscle Energy Technique</intervention_name>
    <description>Firstly, 5-7 sec opposite isometric muscle contraction was requested from the patient in the barrier by passively stretching by the physiotherapist until the barrier of the related muscle or dysfunctional joint. After a short rest period of 2-3 seconds, the physiotherapist continued to stretch passively until the second barrier. The application continued until the tension of the muscle or dysfunction of the joint disappeared.</description>
    <arm_group_label>Muscle Energy Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Only Exercise (Control)</intervention_name>
    <description>Eccentric training for the extensor Carpi Radialis Brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercise for the EKRB muscle were given as home exercise program. The best stretching position for the EKRB tendon is provided when the elbow joint is in extension, forearm pronation, when the wrist is flexed with ulnar deviation (Mills maneuver). Each exercise was taught to patients in 10 repetitions and 10 seconds, and one day of the week, participants in the control group performed their exercises under the supervision of a physiotherapist.</description>
    <arm_group_label>Only Exercise (Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosing lateral epicondylitis&#xD;
&#xD;
          -  Age between 30 and 60 years&#xD;
&#xD;
          -  Willingness to comply with treatment and follow-up assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment of elbow complaints with surgical intervention&#xD;
&#xD;
          -  Physiotherapy or CSIs in the past 6 months&#xD;
&#xD;
          -  Duration of &lt;3 months&#xD;
&#xD;
          -  Severe neck or shoulder problems likely to cause or maintain the elbow complaints&#xD;
&#xD;
          -  Posterior interosseous nerve compression&#xD;
&#xD;
          -  Congenital or acquired deformities of the elbow&#xD;
&#xD;
          -  Systemic musculoskeletal or neurologic disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayram Sönmez ÜNÜVAR</last_name>
    <role>Principal Investigator</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KTO Karatay University</name>
      <address>
        <city>Konya</city>
        <zip>42020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tennis Elbow</keyword>
  <keyword>Exercise</keyword>
  <keyword>Musculoskeletal Manipulations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <!-- 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/NCT04505215
org study id: KaratayUS
nct id: NCT04505215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the effects of mulligan and muscle energy techniques on pain, grip strength
      and functionality will be investigated in a randomized controlled manner in individuals with
      lateral epicondylitis. Various treatments have been tried in patients with lateral
      epicondylitis whose daily activities are restricted in order to reduce pain and increase
      functions. Among them, conservative and physical therapy agents have an important place.
      There are many studies in the literature evaluating the effects of mobilization in LE
      treatment. However, there are no definitive data on the long-term efficacy and benefits of
      all these treatment methods. Mulligan and muscle energy techniques can be used in lateral
      epicondylitis due to many positive reasons such as being effective in a short time, giving
      fast results, high success rate, risk-free and painless in the case of specialists. Thanks to
      the findings obtained from our study, it is aimed to contribute to the literature with
      objective, evidence-based results in this field.
Lateral epicondylitis (LE); It is one of the most common lesions of the upper limb,
      originating from the wrist and wrist extensor muscles, characterized by pain in the lateral
      epicondyle and extensor muscle surface of the forearm. LE was first described by Runge in
      1873 and was named tennis elbow by Morris in 1882. It is thought that the cause of LE is
      caused by repetitive stresses, direct traumas, repetitive contractions, degeneration, micro
      tears, immature repair and tendinosis at the adhesion of the extensor carpi radialis brevis
      and extensor digitorum communis muscles. It is mostly seen in 4-6 decades. More dominant
      upper limb is affected. Its annual incidence has been determined between 1-3%. It has been
      shown that it can cause a significant loss of labor due to pain in patients.

      The Mulligan Concept is a new approach in Manual Therapy. It was started to be developed by
      New Zealand physiotherapist Brian Mulligan in the 1980s, and its popularity and awareness has
      increased in the last 10 years. The concept-specific techniques called NAGS, SNAGS and MWMs
      are applied safely and effectively in musculoskeletal-nervous system diseases. The concept is
      suitable for biomechanics, arthrokinematic kinesiological principles, which are the common
      knowledge of the known Manual Therapy approaches, and techniques and application principles
      are important with other approaches. show differences.

      Manual therapy and forearm extensor muscle strengthening are used together with MWM
      (mobilization with movement) technique. MWM eliminates elbow pain by reducing abnormal
      facilitations and creates some tactile and compressive stimuli in soft tissue. Afferent nerve
      activity results in these tactile and compressive stimuli inhibiting spinal cord neurons.
      Force is applied at long load at low load. Increases the harmony and mobility of connective
      tissue layers.

      Mulligan concept; It can be defined as a combination of passive mobilization concepts such as
      Kaltenborn, Maitland Cyriax, and active methods such as Pilates, PNF and Kinetic Control. The
      distinctive feature of this approach is that, when the right case is chosen, the pain can be
      achieved, functional gains can be achieved in a very short time and in the long term.

      Postisometric reconstruction: muscle energy technique (MET) is a manual therapy that uses
      muscle's own energy in the form of mild isometric contractions to relax and lengthen muscles
      through autogenic or mutual inhibition. Compared to static stretching, a passive technique in
      which the therapist does all the work, MET is an active technique in which the patient is
      also an active participant. BAT is based on the concepts of Autogenic Inhibition and Mutual
      Inhibition. If a maximum contraction of the muscle is followed by the stretching of the same
      muscle, Autogenic Inhibition is known as MET, and if the opposite muscle following a maximum
      contraction of the muscle is stretched, it is known as Mutual Inhibition MET.

      The manipulative treatment acts directly on the joint structures and creates a nociceptive
      afferent stimulation by providing physiological effect on the central nervous system. Such
      findings emphasize the appropriateness of the local movements of mobilization. Such a
      mechanism may include intranoral circulation, axoplasmic flow, or neural connective tissue
      viscoelasticity. However, an increasing number of studies have shown that passive joint
      movements can activate many areas.

      Exercise programs are the most common physiotherapy treatments for LE. There are many studies
      examining the effects of exercise programs in LE. Stretching and strengthening exercises are
      at the core of the exercise program. Because the tendon should not only be strengthened, it
      should be flexible. Home exercises should usually be done once or twice a day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline in Hand Grip Strenght at 6 weeks
time frame: Baseline and 4 weeks
description: The maximum grip force measurements of the patients were made with "Baseline Hydraulic Hand Dynamometer". The patient's measurements were carried out in two positions. While the patient was in a sitting position, measurements were made in shoulder adduction, elbow 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ in ulnar deviation position. While the patient was standing, measurement was performed with shoulder adduction, elbow extension, forearm in neutral position. For maximum grip, patients should be able to hold the dynamometer for a maximum of 3 seconds. it was said to tighten with all its might. Measurements were repeated 3 times at 30-second intervals on the affected limb, and the measurements were averaged. Values are noted in kilograms (kg) - force
measure: Change from baseline in Pain Score at 6 weeks
time frame: Baseline and 4 weeks
description: Visual Analogue Scale was used to determine the severity of rest, activity and night pain in patients with lateral epicondylitis. Patients were asked to mark their pain levels on a 10 cm scale before starting treatment and after 4 weeks of treatment. The value "0" means that there is no pain, and the value "10" means unbearable pain. The marked points are measured and recorded in centimeters
measure: Change from baseline in Functionality at 6 weeks
time frame: Baseline and 4 weeks
description: Patient-rated Forearm Evaluation Questionnaire Overend et al. It was designed to evaluate treatment specifically for patients with lateral epicondylitis. Afterwards, it was rearranged by the same working group and named as Patient-rated Forearm Evaluation Questionnaire. The survey consists of 15 questions that question patients' difficulties and pain in the past week. Pain level (5 questions), elbow-related functions (6 questions, special activities, 4 questions daily activities) are evaluated in the first section. The total score ranges from 0 to 100, and high scores indicate increased pain and loss of functionality. In 2010, Altan et al. Turkish version was created by, Patient-rated Forearm Evaluation Questionnaire was found valid and reliable. Turkish version of the questionnaire was used in our study.
arm group label: Mulligan Technique
arm group type: Experimental
description: In addition to the exercises applied to the participants in the control group, the participants in this group used Mobilization with movement, which was performed with the principle of painless movement 3 times a week for a total of 12 times a week for 4 weeks. Mobilization with movement has been performed by a certified physiotherapist who has been practicing this technique for 10 years.
arm group label: Muscle Energy Technique
arm group type: Experimental
description: In addition to the exercises applied to the participants in the control group, the Janda method (Post Isometric Relaxation Technique) from Muscle Energy Technique (3 times a week) was used 3 times a week for 4 weeks.
arm group label: Only Exercise (Control)
arm group type: Active Comparator
description: Stretching and strengthening exercises for the forearm extensors were shown to the participants in the control group for 4 weeks every day of the week.
intervention type: Other
intervention name: Mulligan Technique
description: First, the painless application angle was determined for each patient. The lateral condyle of the humerus was fixed by the web range of the physiotherapist. The elbow joint was glided until the elbow joint and the hand tightening position were not able to cause pain.
The patients were asked to repeat the motion of the elbow joint and the ball squeezing motion given to their hands 10 times without pain. For pain control, the same procedure was performed with three sets, each containing 10 repetitions of the exercise. The interval between sets was 15 to 20 seconds, and the interval between repetitions within each set was 30 seconds.
arm group label: Mulligan Technique
intervention type: Other
intervention name: Muscle Energy Technique
description: Firstly, 5-7 sec opposite isometric muscle contraction was requested from the patient in the barrier by passively stretching by the physiotherapist until the barrier of the related muscle or dysfunctional joint. After a short rest period of 2-3 seconds, the physiotherapist continued to stretch passively until the second barrier. The application continued until the tension of the muscle or dysfunction of the joint disappeared.
arm group label: Muscle Energy Technique
intervention type: Other
intervention name: Only Exercise (Control)
description: Eccentric training for the extensor Carpi Radialis Brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercise for the EKRB muscle were given as home exercise program. The best stretching position for the EKRB tendon is provided when the elbow joint is in extension, forearm pronation, when the wrist is flexed with ulnar deviation (Mills maneuver). Each exercise was taught to patients in 10 repetitions and 10 seconds, and one day of the week, participants in the control group performed their exercises under the supervision of a physiotherapist.
arm group label: Only Exercise (Control)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Bayram Sönmez ÜNÜVAR
role: Principal Investigator
affiliation: KTO Karatay University
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Tennis Elbow