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/NCT05976724</url>
    </required_header>
    <id_info>
      <org_study_id>12068451744</org_study_id>
      <nct_id>NCT05976724</nct_id>
    </id_info>
    <brief_title>Mobilization With Movement in Distal Radial Fractures</brief_title>
    <official_title>Investigation of the Effectiveness of Movement With Mobilization Technique for Distal Radial Fractures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahi Evran University Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahi Evran University Education and Research Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Distal radius fractures (DRF) are the most common upper extremity disorders encountered in&#xD;
        clinical practice. With an understanding of the mechanics of distal radius fractures,&#xD;
        surgical intervention, and bone healing, the therapist can modify the therapy program&#xD;
        according to the patient's individual needs. The therapeutic process is begun in the crucial&#xD;
        stage of bone healing during fracture immobilization. By addressing edema reduction and early&#xD;
        range of motion of the uninvolved joints, most problems can be avoided before cast or fixator&#xD;
        removal. Rehabilitation following the immobilization period should focus on regaining wrist&#xD;
        movements provided that earlier problems have been addressed properly. During the&#xD;
        rehabilitative process, the therapist can incorporate scar management, modalities, joint&#xD;
        mobilization, active and passive range of motion, splinting, and strengthening to maximize&#xD;
        the patient's functional result.&#xD;
  &#xD;
        Massage and mobilization techniques are used in the treatment of DRF due to their analgesic&#xD;
        effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan)&#xD;
        is a manual therapy method applies to correct the limitation of movement in the joint and to&#xD;
        relieve pain and functional disorders. Many studies have shown that MWM technique provides&#xD;
        faster and momentary painless joint movement compared to other physical therapy modalities.&#xD;
        The patient group with DRF has a large place in the general population and long treatment&#xD;
        processes cause both labour loss and economic loss. Therefore, this study aimed to examine&#xD;
        the effectiveness of MWM technique in cases with distal radius fractures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 42 DRF patients with age range 18-65 who applied to Kırşehir Ahi Evran&#xD;
        University Training and Research Hospital were examined. The individuals included in the&#xD;
        study were divided into two groups according to the paired randomization method. These groups&#xD;
        were control and intervention groups. Traditional physiotherapy methods were applied to the&#xD;
        control group, traditional physiotherapy and MWM techniques were applied to the intervention&#xD;
        group. Traditional physiotherapy methods were included; Transcutaneous Electrical Nerve&#xD;
        Stimulation (TENS), stretching and strengthening exercises.&#xD;
  &#xD;
        For the evaluation of patients; Visual Analogue Scale (VAS), wrist goniometric measurements,&#xD;
        grip strength measurement, pinch strength measurement, edema measurement and Munich Wrist&#xD;
        Questionnaire (MWQ) were used.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>0-5 week</time_frame>
      <description>Visual Analogue Scale (VAS). As a simple and commonly applied method, VAS is considered to be both valid and reliable in measuring patient pain intensity. The patients in the current study were each asked with indicating the intensity of their pain experienced within the past 24 hours by marking on a 10-cm line scale, where 0 = &quot;No pain&quot; and 10 = &quot;Maximum pain</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Pain</condition>
    <condition>Acute Pain</condition>
    <condition>Mobility Limitation</condition>
    <arm_group>
      <arm_group_label>Mobilization with movement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mobilization with movement technique and traditional physiotherapy will be applied to the intervention group. Also patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TENS, exercise</intervention_name>
      <description>TENS: The patients were sat in a chair positioned next to a treatment table. The hand to be treated was placed on the treatment table with the forearm in the supine position. Electrodes were then placed on the transverse carpal ligament and palmar surface of the hand. Conventional TENS was applied, with the current transition time set to 50-100 µs, and performed at a frequency of 100 Hz for a period of 20 minutes at an amplitude that did not cause muscle contraction or any feeling of numbness or tingling.&#xD;
  The supervised exercises were performed by the patients in a seated position. Strengthening exercises were performed with both hands by means of Digi-Flex hand exerciser (IMC Products Corp, Hicksville, New York), modeling mass and elastics. The patients were tasked with performing these exercises 10 times in each session and three times daily.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Mobilization with movement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mulligan mobilisation</intervention_name>
      <description>Each participant was tested with sustained manual glides in each of the possible directions during active wrist flexion and extension from the seated position. For the lateral glide, the therapist stabilises the lateral aspect of the distal radius using the first web-space. And glides the proximal row of carpal bones laterally (towards the thumb) using the first web-space of the other hand, following the joint line. For the medial glide, the therapist stabilises the medial aspect of the distal ulna using the first web-space. And glides the proximal row of carpal bones medially (away from the thumb) using the first web-space of the other hand, following the joint line.</description>
      <arm_group_label>Mobilization with movement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with distal radius fracture&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with polytrauma,&#xD;
  &#xD;
            -  open fracture,&#xD;
  &#xD;
            -  ulnar head fracture (excluding ulnar styloid fracture),&#xD;
  &#xD;
            -  history of complex regional pain syndrome,&#xD;
  &#xD;
            -  limited cognitive capacity were excluded&#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_contact>
      <last_name>İsmail Ceylan</last_name>
      <phone>+905364634679</phone>
      <email>fztceylan@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>İsmail Ceylan</name>
        <address>
          <city>Kırşehir</city>
          <state>Merkez</state>
          <zip>40100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>İsmail Ceylan</last_name>
        <phone>05364634679</phone>
        <email>fztceylan@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>İsmail Ceylan</last_name>
        <phone>+905364634679</phone>
        <email>fztceylan@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.</citation>
      <PMID>26559319</PMID>
    </results_reference>
    <results_reference>
      <citation>Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.</citation>
      <PMID>24989067</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahi Evran University Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>İSMAİL CEYLAN</investigator_full_name>
      <investigator_title>Head of hand therapy clinic. PhD.</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Range of motion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
      <mesh_term>Mobility Limitation</mesh_term>
      <mesh_term>Radius Fractures</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/NCT05976724
  org study id: 12068451744
  nct id: NCT05976724
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Distal radius fractures (DRF) are the most common upper extremity disorders encountered in
        clinical practice. With an understanding of the mechanics of distal radius fractures,
        surgical intervention, and bone healing, the therapist can modify the therapy program
        according to the patient's individual needs. The therapeutic process is begun in the crucial
        stage of bone healing during fracture immobilization. By addressing edema reduction and early
        range of motion of the uninvolved joints, most problems can be avoided before cast or fixator
        removal. Rehabilitation following the immobilization period should focus on regaining wrist
        movements provided that earlier problems have been addressed properly. During the
        rehabilitative process, the therapist can incorporate scar management, modalities, joint
        mobilization, active and passive range of motion, splinting, and strengthening to maximize
        the patient's functional result.
  
        Massage and mobilization techniques are used in the treatment of DRF due to their analgesic
        effects. The painless mobilization with movement technique (MWM, developed by Brian Mulligan)
        is a manual therapy method applies to correct the limitation of movement in the joint and to
        relieve pain and functional disorders. Many studies have shown that MWM technique provides
        faster and momentary painless joint movement compared to other physical therapy modalities.
        The patient group with DRF has a large place in the general population and long treatment
        processes cause both labour loss and economic loss. Therefore, this study aimed to examine
        the effectiveness of MWM technique in cases with distal radius fractures.
  In this study, 42 DRF patients with age range 18-65 who applied to Kırşehir Ahi Evran
        University Training and Research Hospital were examined. The individuals included in the
        study were divided into two groups according to the paired randomization method. These groups
        were control and intervention groups. Traditional physiotherapy methods were applied to the
        control group, traditional physiotherapy and MWM techniques were applied to the intervention
        group. Traditional physiotherapy methods were included; Transcutaneous Electrical Nerve
        Stimulation (TENS), stretching and strengthening exercises.
  
        For the evaluation of patients; Visual Analogue Scale (VAS), wrist goniometric measurements,
        grip strength measurement, pinch strength measurement, edema measurement and Munich Wrist
        Questionnaire (MWQ) were used.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Controlled Trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual Analogue Scale (VAS)
  time frame: 0-5 week
  description: Visual Analogue Scale (VAS). As a simple and commonly applied method, VAS is considered to be both valid and reliable in measuring patient pain intensity. The patients in the current study were each asked with indicating the intensity of their pain experienced within the past 24 hours by marking on a 10-cm line scale, where 0 = "No pain" and 10 = "Maximum pain
  arm group label: Mobilization with movement
  arm group type: Experimental
  description: Mobilization with movement technique and traditional physiotherapy will be applied to the intervention group. Also patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises.
  arm group label: Control group
  arm group type: Active Comparator
  description: Patients will receive a traditional therapy program consisting of Conventional TENS and stretching and strengthening exercises.
  intervention type: Other
  intervention name: TENS, exercise
  description: TENS: The patients were sat in a chair positioned next to a treatment table. The hand to be treated was placed on the treatment table with the forearm in the supine position. Electrodes were then placed on the transverse carpal ligament and palmar surface of the hand. Conventional TENS was applied, with the current transition time set to 50-100 µs, and performed at a frequency of 100 Hz for a period of 20 minutes at an amplitude that did not cause muscle contraction or any feeling of numbness or tingling.
  The supervised exercises were performed by the patients in a seated position. Strengthening exercises were performed with both hands by means of Digi-Flex hand exerciser (IMC Products Corp, Hicksville, New York), modeling mass and elastics. The patients were tasked with performing these exercises 10 times in each session and three times daily.
  arm group label: Control group
  arm group label: Mobilization with movement
  intervention type: Other
  intervention name: Mulligan mobilisation
  description: Each participant was tested with sustained manual glides in each of the possible directions during active wrist flexion and extension from the seated position. For the lateral glide, the therapist stabilises the lateral aspect of the distal radius using the first web-space. And glides the proximal row of carpal bones laterally (towards the thumb) using the first web-space of the other hand, following the joint line. For the medial glide, the therapist stabilises the medial aspect of the distal ulna using the first web-space. And glides the proximal row of carpal bones medially (away from the thumb) using the first web-space of the other hand, following the joint line.
  arm group label: Mobilization with movement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: İsmail Ceylan
  phone: +905364634679
  email: fztceylan@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  citation: Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.
  PMID: 26559319
  citation: Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.
  PMID: 24989067
  responsible party type: Principal Investigator
  investigator affiliation: Ahi Evran University Education and Research Hospital
  investigator full name: İSMAİL CEYLAN
  investigator title: Head of hand therapy clinic. PhD.
  mesh term: Acute Pain
  mesh term: Mobility Limitation
  mesh term: Radius Fractures
  sharing ipd: No