xml: <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/NCT06001944</url>
    </required_header>
    <id_info>
      <org_study_id>665912</org_study_id>
      <nct_id>NCT06001944</nct_id>
    </id_info>
    <brief_title>Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy</brief_title>
    <official_title>Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The investigators believe that blood flow-restricted training can result in increased caste&#xD;
        hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that&#xD;
        changes in local metabolic activities can be effective in the process of tendon healing. The&#xD;
        researchers' aim in the study is to investigate the effectiveness of blood flow restriction&#xD;
        training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week&#xD;
        multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50%&#xD;
        occlusion recommended for the upper extremity using the patient's systolic pressure to the&#xD;
        severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions&#xD;
        and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes&#xD;
        period for the top extremity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Physiotherapy is the first step in the treatment algorithm for lateral elbow tendinopathy&#xD;
        (LET), which is characterized by pain in the lateral epicondyl of the humerus during wrist&#xD;
        extension and which limits hand-to-hand movements such as grabbing and thinning and&#xD;
        consequently negatively affects hand functions. Extender carpi radialis brevis (ECRB) and&#xD;
        extender digitorum, communis (EDC) are the muscles that contribute most to the onset of&#xD;
        symptoms. Exercise, either alone or as part of a multimodal physiotherapy program, is central&#xD;
        to the management of many patients with LDT. Exercise in patients with chronic LDT has been&#xD;
        shown to result in more and faster relief of pain, less use of illness, less medical&#xD;
        consultation, and increased working capacity. In literature, loading with recommended&#xD;
        exercises is considered necessary to re-form the tendon, while on the other hand some&#xD;
        patients may not tolerate this loading. For rehabilitation practitioners, it is quite&#xD;
        difficult to design optimal exercise programs that facilitate musculo-skeletal system (MSK)&#xD;
        adaptations while also enabling biological healing and safe loading of the injured body. In&#xD;
        these cases, there has been a search for a new method that can generate physiological&#xD;
        benefits associated with higher intensity training with exercise at lower loads. Increasing&#xD;
        evidence supports the use of resistance training at a reduced load along with blood flow&#xD;
        restriction (BFR) therapy to increase hypertrophic and force responses in skeletal muscle.&#xD;
        The American Association of Sports Physicians (ACSM) recommends that at least 65% of the 1&#xD;
        maximum repetition, similar to exercising at high intensity with 8-12 repetition resistant&#xD;
        weight lifting strength training, can be used in low loads such as 20% to 30% of 1 maximum&#xD;
        repeat in the treatment to caste hypertrophy and strength. Effects of blood flow-restricted&#xD;
        training on muscle lithium excitement, mechanical tension, metabolic stress, systemic and&#xD;
        local hormones, vascular endothelial growth factor (VEGF) and oxidative stress mechanisms&#xD;
        have been. There have been no randomized controlled studies in the literature on the&#xD;
        effectiveness of BFR training in tendinopathies. However, case studies and series of cases&#xD;
        have been included and no contraindications of BFR have been for patients with tendinopathy.&#xD;
        The increasing number of studies on various diseases in the literature is a proof of this.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 11, 2023</start_date>
    <completion_date type="Anticipated">April 11, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 11, 2024</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Painless Grip Strength</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient-rated tennis elbow evaluation (PRTEE)</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SF-12 Quality of Life Questionnaire</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>The SF-12 consist of 12 items assesing physical and mental health and yields 2 summary scores; the mental component summary and physical component summary. Scoring is norm based with a mean of 50; higher scores indicate better health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Rating of Change</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>Global rating of change scale quantifies a patient's improvement or deterioration over time, and identifies the effect of an intervention or charts the clinical course of a condition. The patient selects between &quot;much worse&quot;, &quot;slightly worse&quot;, &quot;stayed at same&quot;, &quot;slightly better&quot; and, &quot;much better&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>The range of motion clarity of the shoulder, elbow, front arm and wrist joints in resting position using the gonyometer will be tested.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Manual Muscle Testing</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>The upper, middle and lower trapezoidal muscles, serratus anterior, biceps brachii and triceps brachii will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pressure-Pain Threshold Measurement</measure>
      <time_frame>Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up</time_frame>
      <description>An algometer is a device consisting of a frame displaying the pressure to be applied to this piston with a metal piston containing a round disk of about 1 cm in diameter at the end. The algometer will be asked to tell the patient the level of discomfort by pressing it at a straight angle to the most sensitive area in the lateral epicondyl area. The pressure value for the pain sensation will be determined as the pain threshold and the values obtained in kilograms (kg) will be recorded.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">69</enrollment>
    <condition>Lateral Epicondylitis</condition>
    <condition>Tennis Elbow</condition>
    <condition>Tendonitis Elbow</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>8 weeks, 2 days a week, a multi-model rehabilitation program is implemented.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood flow restriction</intervention_name>
      <description>The BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Multimodal rehabilitation</intervention_name>
      <description>Patients with LDT will be informed that the condition will be gradually resolved with adequate rest and time.&#xD;
  Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between 18 and 65 years of age,&#xD;
  &#xD;
            -  Lateral tendinopathy diagnosis,&#xD;
  &#xD;
            -  Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test&#xD;
               (PRTEE).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dysfunction in the shoulder, neck and/or chest area,&#xD;
  &#xD;
            -  Local or generalized arthritis.&#xD;
  &#xD;
            -  The neurological deficit.&#xD;
  &#xD;
            -  Radial dysfunction,&#xD;
  &#xD;
            -  Limitation of arm functions,&#xD;
  &#xD;
            -  A history of shoulder or upper extremity pathology requiring surgery or treatment;&#xD;
  &#xD;
            -  Venous thromboembolism&#xD;
  &#xD;
            -  Inflammation or other hematological disorders.&#xD;
  &#xD;
            -  Coronary artery disease,&#xD;
  &#xD;
            -  Peripheral arterial disease or hypertension (systolic/diastolic blood pressure &gt;140 mm&#xD;
               Hg/90 mmHg),&#xD;
  &#xD;
            -  To be pregnant,&#xD;
  &#xD;
            -  Irritation of median nerves.&#xD;
  &#xD;
            -  Irritation of radial nerves.&#xD;
  &#xD;
            -  Irritation of the ulnar nerves,&#xD;
  &#xD;
            -  The pain score is less than 30 mm.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yıldız ANALAY AKBABA, Assoc. prof.</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fulya DEMIRHAN, PHd Student</last_name>
      <phone>+90-532-353-2208</phone>
      <email>f.gurcenan@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yıldız ANALAY AKBABA, Assoc.prof.</last_name>
      <phone>+90-532-377-4013</phone>
      <email>yildizanalay@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istanbul University - Cerrahpasa</name>
        <address>
          <city>Istanbul</city>
          <state>Büyükçekmece</state>
          <zip>No:5/9/1</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fulya DEMIRHAN, PHd Student</last_name>
        <phone>+90-532-353-2208</phone>
        <email>f.gurcenan@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440.</citation>
      <PMID>33002980</PMID>
    </reference>
    <reference>
      <citation>Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.</citation>
      <PMID>31543413</PMID>
    </reference>
    <reference>
      <citation>Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13.</citation>
      <PMID>36099170</PMID>
    </reference>
    <reference>
      <citation>Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.</citation>
      <PMID>26381484</PMID>
    </reference>
    <reference>
      <citation>Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Mar 11:S0894-1130(22)00113-2. doi: 10.1016/j.jht.2022.11.005. Online ahead of print.</citation>
      <PMID>36914496</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Fulya Demirhan</investigator_full_name>
      <investigator_title>Clinical Researcher</investigator_title>
    </responsible_party>
    <keyword>lateral elbow tendinopathy</keyword>
    <keyword>blood flow restriction</keyword>
    <keyword>exercise</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tendinopathy</mesh_term>
      <mesh_term>Tennis Elbow</mesh_term>
      <mesh_term>Elbow Tendinopathy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001944
  org study id: 665912
  nct id: NCT06001944
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The investigators believe that blood flow-restricted training can result in increased caste
        hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that
        changes in local metabolic activities can be effective in the process of tendon healing. The
        researchers' aim in the study is to investigate the effectiveness of blood flow restriction
        training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week
        multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50%
        occlusion recommended for the upper extremity using the patient's systolic pressure to the
        severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions
        and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes
        period for the top extremity.
  Physiotherapy is the first step in the treatment algorithm for lateral elbow tendinopathy
        (LET), which is characterized by pain in the lateral epicondyl of the humerus during wrist
        extension and which limits hand-to-hand movements such as grabbing and thinning and
        consequently negatively affects hand functions. Extender carpi radialis brevis (ECRB) and
        extender digitorum, communis (EDC) are the muscles that contribute most to the onset of
        symptoms. Exercise, either alone or as part of a multimodal physiotherapy program, is central
        to the management of many patients with LDT. Exercise in patients with chronic LDT has been
        shown to result in more and faster relief of pain, less use of illness, less medical
        consultation, and increased working capacity. In literature, loading with recommended
        exercises is considered necessary to re-form the tendon, while on the other hand some
        patients may not tolerate this loading. For rehabilitation practitioners, it is quite
        difficult to design optimal exercise programs that facilitate musculo-skeletal system (MSK)
        adaptations while also enabling biological healing and safe loading of the injured body. In
        these cases, there has been a search for a new method that can generate physiological
        benefits associated with higher intensity training with exercise at lower loads. Increasing
        evidence supports the use of resistance training at a reduced load along with blood flow
        restriction (BFR) therapy to increase hypertrophic and force responses in skeletal muscle.
        The American Association of Sports Physicians (ACSM) recommends that at least 65% of the 1
        maximum repetition, similar to exercising at high intensity with 8-12 repetition resistant
        weight lifting strength training, can be used in low loads such as 20% to 30% of 1 maximum
        repeat in the treatment to caste hypertrophy and strength. Effects of blood flow-restricted
        training on muscle lithium excitement, mechanical tension, metabolic stress, systemic and
        local hormones, vascular endothelial growth factor (VEGF) and oxidative stress mechanisms
        have been. There have been no randomized controlled studies in the literature on the
        effectiveness of BFR training in tendinopathies. However, case studies and series of cases
        have been included and no contraindications of BFR have been for patients with tendinopathy.
        The increasing number of studies on various diseases in the literature is a proof of this.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.
  measure: Visual Analog Scale
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.
  measure: Painless Grip Strength
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.
  measure: Patient-rated tennis elbow evaluation (PRTEE)
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.
  measure: SF-12 Quality of Life Questionnaire
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: The SF-12 consist of 12 items assesing physical and mental health and yields 2 summary scores; the mental component summary and physical component summary. Scoring is norm based with a mean of 50; higher scores indicate better health.
  measure: Global Rating of Change
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: Global rating of change scale quantifies a patient's improvement or deterioration over time, and identifies the effect of an intervention or charts the clinical course of a condition. The patient selects between "much worse", "slightly worse", "stayed at same", "slightly better" and, "much better".
  measure: Range of Motion
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: The range of motion clarity of the shoulder, elbow, front arm and wrist joints in resting position using the gonyometer will be tested.
  measure: Manual Muscle Testing
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: The upper, middle and lower trapezoidal muscles, serratus anterior, biceps brachii and triceps brachii will be evaluated.
  measure: Pressure-Pain Threshold Measurement
  time frame: Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
  description: An algometer is a device consisting of a frame displaying the pressure to be applied to this piston with a metal piston containing a round disk of about 1 cm in diameter at the end. The algometer will be asked to tell the patient the level of discomfort by pressing it at a straight angle to the most sensitive area in the lateral epicondyl area. The pressure value for the pain sensation will be determined as the pain threshold and the values obtained in kilograms (kg) will be recorded.
  arm group label: Control group
  arm group type: Active Comparator
  description: 8 weeks, 2 days a week, a multi-model rehabilitation program is implemented.
  arm group label: Experimental group
  arm group type: Experimental
  description: 8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets.
  intervention type: Other
  intervention name: Blood flow restriction
  description: The BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength.
  arm group label: Experimental group
  intervention type: Other
  intervention name: Multimodal rehabilitation
  description: Patients with LDT will be informed that the condition will be gradually resolved with adequate rest and time.
  Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Yıldız ANALAY AKBABA, Assoc. prof.
  role: Study Chair
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Fulya DEMIRHAN, PHd Student
  phone: +90-532-353-2208
  email: f.gurcenan@hotmail.com
  last name: Yıldız ANALAY AKBABA, Assoc.prof.
  phone: +90-532-377-4013
  email: yildizanalay@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440.
  PMID: 33002980
  citation: Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
  PMID: 31543413
  citation: Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13.
  PMID: 36099170
  citation: Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
  PMID: 26381484
  citation: Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Mar 11:S0894-1130(22)00113-2. doi: 10.1016/j.jht.2022.11.005. Online ahead of print.
  PMID: 36914496
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Fulya Demirhan
  investigator title: Clinical Researcher
  mesh term: Tendinopathy
  mesh term: Tennis Elbow
  mesh term: Elbow Tendinopathy
  sharing ipd: No