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/NCT05976256</url>
    </required_header>
    <id_info>
      <org_study_id>WO 21.210</org_study_id>
      <nct_id>NCT05976256</nct_id>
    </id_info>
    <brief_title>Kinesiotaping in Trauma</brief_title>
    <acronym>KIT</acronym>
    <official_title>Kinesiotaping in Trauma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Onze Lieve Vrouwe Gasthuis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>OLVG</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Onze Lieve Vrouwe Gasthuis</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>
        Rationale: Patients with acute traumatic injury to the shoulder or chest wall in de Emergency&#xD;
        Department (ED) usually have intense pain. The patient normally is treated with oral&#xD;
        analgesics as standard care and in shoulder injury with a sling. Pain of the shoulder or&#xD;
        chest wall increases with movement of the affected arm and chest. Kinesiotaping is offered&#xD;
        regularly as an additional pain treatment, but there is no hard evidence about its&#xD;
        effectiveness. A randomized pilot study in OLVG (Bakker 2022) showed the pain decreasing more&#xD;
        when using kinesiotaping comparing to no tape. However, a placebo-effect could not be ruled&#xD;
        out and the pilot data need confirmation in a large cohort of patients to study the&#xD;
        effectiveness of additional treatment with kinesiotaping in terms of pain, comfort and&#xD;
        patient satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: The primary aim of this study is to evaluate the effect of kinesiotaping on number&#xD;
        of patients with clinically meaningful pain reduction after 1 week in patients with acute&#xD;
        traumatic injury in shoulder or chest wall, compared to sham tape and no tape. The secondary&#xD;
        aims are to assess the effect of kinesiotaping on pain reduction at 15 min, 3 weeks and 8&#xD;
        weeks, and the effects on the skin, use of oral analgesics, independence, activity pattern,&#xD;
        progress of pain symptoms, comfort and patient satisfaction at 1, 3 and 8 weeks. Also the&#xD;
        need of physiotherapy is one of the secondary aims.&#xD;
  &#xD;
        Study design: Parallel randomized controlled trial with three arms&#xD;
  &#xD;
        Study population: Patients of or over 18 years old with an acute single shoulder or chest&#xD;
        wall injury (rib fracture, disruption of the acromioclavicular (AC) joint Tossy type 1 and 2,&#xD;
        not or hardly dislocated fracture of clavicle or proximal humeral bone).&#xD;
  &#xD;
        Intervention (if applicable): One group will receive treatment with kinesiotaping, another&#xD;
        group receives sham taping (no elastic tape) and the third group receives no taping. This&#xD;
        treatment is additional to the general treatment with oral analgesics and a sling (when&#xD;
        shoulder injury).&#xD;
  &#xD;
        Main study parameters/endpoints: The main study parameter is the proportion of patients who&#xD;
        experienced a clinically meaningful reduction in pain score (≥2 points on NRS) at week 1&#xD;
        compared to T1. The kinesiotape group will be compared to the sham group and to the control&#xD;
        group.&#xD;
  &#xD;
        Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
        relatedness:&#xD;
  &#xD;
        At 15 minutes after receiving kinesio tape, sham tape or no tape, 1 week, 3 weeks and 8 weeks&#xD;
        after visiting the emergency department the pain of these patients is evaluated using NRS by&#xD;
        the Brief Pain Inventory (BPI). The effect of use of oral analgesics (questionnaire), on the&#xD;
        skin (questionnaire), on independence, activity pattern and progress of pain symptoms&#xD;
        (Groningen Activity Restriction Scale (GARS)), comfort and patient satisfaction (Global&#xD;
        Perceived Effect (GPE-DV)) is evaluated after 1, 3 and 8 weeks. Physiotherapy is elevated&#xD;
        after 8 weeks. Due to the limited seriousness of the injury and the non-invasive nature of&#xD;
        the interventions, any serious complication or adverse event is not expected. Benefits of&#xD;
        participating this study could be pain reduction in the affected body part.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</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>RCT</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>number of patients with clinically meaningful pain reduction</measure>
      <time_frame>1 week</time_frame>
      <description>To evaluate the effect of kinesiotaping on number of patients with clinically meaningful pain reduction (Brief Pain Inventory (BPI)) after 1 week in patients with acute traumatic injury in shoulder or chest wall, compared to sham tape and no tape (2 comparisons).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>number of patients with clinically meaningful pain reduction</measure>
      <time_frame>after 15 minutes, 3 weeks and 8 weeks</time_frame>
      <description>the proportion of patients who experience a clinically meaningful reduction in pain score (≥2 points on NRS by BPI). The kinesiotape group will be compared to the sham group and to the control group (2 comparisons).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluating skin defects by questionnaire</measure>
      <time_frame>1 week, 3 weeks and 8 weeks</time_frame>
      <description>To assess potential skin abnormalities resulting from kinesio taping, a questionnaire will be distributed among the participants. This questionnaire is designed based on the decubitus stages. Additionally, in case of skin abnormalities or rashes, participants will be requested to upload a photograph of the affected area for independent evaluation of the skin condition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluating use of oral analgesics by questionnaire</measure>
      <time_frame>after 1 week, 3 weeks and 8 weeks</time_frame>
      <description>To evaluate the utilization of oral analgesics, a questionnaire is administered to the participants to ascertain the type of medication employed, as well as to quantify the frequency and dosage of its usage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluating independence, pattern of activity and course of pain complaints by Groningen Activity Restriction Scale (GARS)</measure>
      <time_frame>after 1 week, 3 weeks and 8 weeks</time_frame>
      <description>To delineate the independence, pattern of activity, and course of pain complaints, we employ the Groningen Activity Restriction Scale (GARS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)</measure>
      <time_frame>after 15 minutes, 1 week, 3 weeks and 8 weeks</time_frame>
      <description>To gauge comfort and patient satisfaction, the Global Perceived Effect (GPE-DV) is utilized as a measurement tool.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluating the need of physiotherapy by questionnaire</measure>
      <time_frame>8 weeks</time_frame>
      <description>To gain insight into whether patients avail or have availed themselves of physiotherapy, a questionnaire is dispatched after 8 weeks, encompassing queries regarding the utilization of physiotherapy during the treatment period, its frequency, and the nature of the treatment sought.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>clinical meaningful pain reduction for the different intervention arms</measure>
      <time_frame>15 min, 1 week, 3 weeks and 8 weels</time_frame>
      <description>In an exploratory analysis, we would like to assess in a subgroup analysis if the number of patients with clinically meaningful pain reduction after 15 minutes, 1 week, 3 weeks and 8 weeks for the different intervention arms differs between patients with uncomplicated rib fracture, disruption of the AC-joint, clavicle fracture, and proximal humeral fracture (using the BPI-NRS)</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">387</enrollment>
    <condition>Fracture Rib</condition>
    <condition>Acromioclavicular Joint Dislocation</condition>
    <condition>Fracture Clavicle</condition>
    <condition>Fracture, Proximal Humeral</condition>
    <arm_group>
      <arm_group_label>Kinesiotape</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receives the additional treatment with kinesiotaping (and also standard treament)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sham tape</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patient receives the standard treamtment without additional tape treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Kinesio taping</intervention_name>
      <description>Kinesio tape is a thin, elastic tape that applies pressure to the skin (because of the elasticity of the tape), reducing pain by reducing nociceptive stimulation.</description>
      <arm_group_label>sham tape</arm_group_label>
      <other_name>Leukotape K</other_name>
      <other_name>medical taping</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sham tape (leukotape classic)</intervention_name>
      <description>leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape</description>
      <arm_group_label>Kinesiotape</arm_group_label>
      <other_name>non elastic tape</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standard treatment</intervention_name>
      <description>standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)</description>
      <arm_group_label>Kinesiotape</arm_group_label>
      <arm_group_label>sham tape</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years&#xD;
  &#xD;
            -  Acute injury (occurred &lt;24 hours ago)&#xD;
  &#xD;
            -  Single shoulder or chest wall injury, which includes one of the following injuries:&#xD;
  &#xD;
                 -  rib fracture&#xD;
  &#xD;
                 -  disruption of the AC-joint Tossy type 1 and 2&#xD;
  &#xD;
                 -  not or hardly dislocated fracture of the clavicle&#xD;
  &#xD;
                 -  Not or hardly dislocated fracture of the r proximal humeral fracture&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Patients younger than 18 years&#xD;
  &#xD;
                 -  Incapacitated persons&#xD;
  &#xD;
                 -  Refusal of participation&#xD;
  &#xD;
                 -  Intubation indication&#xD;
  &#xD;
                 -  Decrease of Consciousness&#xD;
  &#xD;
                 -  Hemodynamic instability&#xD;
  &#xD;
                 -  3 or more rib fractures&#xD;
  &#xD;
                 -  Rib fracture rib 1-3&#xD;
  &#xD;
                 -  Indication for surgery&#xD;
  &#xD;
                 -  Hospitalization required&#xD;
  &#xD;
                 -  Presence of a haemo- or pneumothorax with chest drain indication&#xD;
  &#xD;
                 -  Already known with allergy for adhesive tape&#xD;
  &#xD;
                 -  Patients with very thin or loose skin on the applicable body part&#xD;
  &#xD;
                 -  Skin infection/irritation or open wound on the applicable body part&#xD;
  &#xD;
                 -  Patients who do not speak Dutch or English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mireille Bakker, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>OLVG</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maro Sandel, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>OLVG</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Carel Goslings, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>OLVG</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Janneke Schuitenmaker, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>OLVG</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mireille Bakker, MSc</last_name>
      <phone>+310205999111</phone>
      <email>m.e.bakker2@olvg.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maro Sandel, MD, PhD</last_name>
      <phone>+310205999111</phone>
      <email>m.sandel@olvg.nl</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>kinesiotaping</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Dislocations</mesh_term>
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Shoulder 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/NCT05976256
  org study id: WO 21.210
  nct id: NCT05976256
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Rationale: Patients with acute traumatic injury to the shoulder or chest wall in de Emergency
        Department (ED) usually have intense pain. The patient normally is treated with oral
        analgesics as standard care and in shoulder injury with a sling. Pain of the shoulder or
        chest wall increases with movement of the affected arm and chest. Kinesiotaping is offered
        regularly as an additional pain treatment, but there is no hard evidence about its
        effectiveness. A randomized pilot study in OLVG (Bakker 2022) showed the pain decreasing more
        when using kinesiotaping comparing to no tape. However, a placebo-effect could not be ruled
        out and the pilot data need confirmation in a large cohort of patients to study the
        effectiveness of additional treatment with kinesiotaping in terms of pain, comfort and
        patient satisfaction.
  Objective: The primary aim of this study is to evaluate the effect of kinesiotaping on number
        of patients with clinically meaningful pain reduction after 1 week in patients with acute
        traumatic injury in shoulder or chest wall, compared to sham tape and no tape. The secondary
        aims are to assess the effect of kinesiotaping on pain reduction at 15 min, 3 weeks and 8
        weeks, and the effects on the skin, use of oral analgesics, independence, activity pattern,
        progress of pain symptoms, comfort and patient satisfaction at 1, 3 and 8 weeks. Also the
        need of physiotherapy is one of the secondary aims.
  
        Study design: Parallel randomized controlled trial with three arms
  
        Study population: Patients of or over 18 years old with an acute single shoulder or chest
        wall injury (rib fracture, disruption of the acromioclavicular (AC) joint Tossy type 1 and 2,
        not or hardly dislocated fracture of clavicle or proximal humeral bone).
  
        Intervention (if applicable): One group will receive treatment with kinesiotaping, another
        group receives sham taping (no elastic tape) and the third group receives no taping. This
        treatment is additional to the general treatment with oral analgesics and a sling (when
        shoulder injury).
  
        Main study parameters/endpoints: The main study parameter is the proportion of patients who
        experienced a clinically meaningful reduction in pain score (≥2 points on NRS) at week 1
        compared to T1. The kinesiotape group will be compared to the sham group and to the control
        group.
  
        Nature and extent of the burden and risks associated with participation, benefit and group
        relatedness:
  
        At 15 minutes after receiving kinesio tape, sham tape or no tape, 1 week, 3 weeks and 8 weeks
        after visiting the emergency department the pain of these patients is evaluated using NRS by
        the Brief Pain Inventory (BPI). The effect of use of oral analgesics (questionnaire), on the
        skin (questionnaire), on independence, activity pattern and progress of pain symptoms
        (Groningen Activity Restriction Scale (GARS)), comfort and patient satisfaction (Global
        Perceived Effect (GPE-DV)) is evaluated after 1, 3 and 8 weeks. Physiotherapy is elevated
        after 8 weeks. Due to the limited seriousness of the injury and the non-invasive nature of
        the interventions, any serious complication or adverse event is not expected. Benefits of
        participating this study could be pain reduction in the affected body part.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: RCT
  primary purpose: Treatment
  masking: Single (Participant)
  measure: number of patients with clinically meaningful pain reduction
  time frame: 1 week
  description: To evaluate the effect of kinesiotaping on number of patients with clinically meaningful pain reduction (Brief Pain Inventory (BPI)) after 1 week in patients with acute traumatic injury in shoulder or chest wall, compared to sham tape and no tape (2 comparisons).
  measure: number of patients with clinically meaningful pain reduction
  time frame: after 15 minutes, 3 weeks and 8 weeks
  description: the proportion of patients who experience a clinically meaningful reduction in pain score (≥2 points on NRS by BPI). The kinesiotape group will be compared to the sham group and to the control group (2 comparisons).
  measure: evaluating skin defects by questionnaire
  time frame: 1 week, 3 weeks and 8 weeks
  description: To assess potential skin abnormalities resulting from kinesio taping, a questionnaire will be distributed among the participants. This questionnaire is designed based on the decubitus stages. Additionally, in case of skin abnormalities or rashes, participants will be requested to upload a photograph of the affected area for independent evaluation of the skin condition.
  measure: evaluating use of oral analgesics by questionnaire
  time frame: after 1 week, 3 weeks and 8 weeks
  description: To evaluate the utilization of oral analgesics, a questionnaire is administered to the participants to ascertain the type of medication employed, as well as to quantify the frequency and dosage of its usage.
  measure: evaluating independence, pattern of activity and course of pain complaints by Groningen Activity Restriction Scale (GARS)
  time frame: after 1 week, 3 weeks and 8 weeks
  description: To delineate the independence, pattern of activity, and course of pain complaints, we employ the Groningen Activity Restriction Scale (GARS).
  measure: Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)
  time frame: after 15 minutes, 1 week, 3 weeks and 8 weeks
  description: To gauge comfort and patient satisfaction, the Global Perceived Effect (GPE-DV) is utilized as a measurement tool.
  measure: Evaluating the need of physiotherapy by questionnaire
  time frame: 8 weeks
  description: To gain insight into whether patients avail or have availed themselves of physiotherapy, a questionnaire is dispatched after 8 weeks, encompassing queries regarding the utilization of physiotherapy during the treatment period, its frequency, and the nature of the treatment sought.
  measure: clinical meaningful pain reduction for the different intervention arms
  time frame: 15 min, 1 week, 3 weeks and 8 weels
  description: In an exploratory analysis, we would like to assess in a subgroup analysis if the number of patients with clinically meaningful pain reduction after 15 minutes, 1 week, 3 weeks and 8 weeks for the different intervention arms differs between patients with uncomplicated rib fracture, disruption of the AC-joint, clavicle fracture, and proximal humeral fracture (using the BPI-NRS)
  arm group label: Kinesiotape
  arm group type: Active Comparator
  description: Patients receives the additional treatment with kinesiotaping (and also standard treament)
  arm group label: sham tape
  arm group type: Sham Comparator
  description: patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)
  arm group label: control group
  arm group type: No Intervention
  description: patient receives the standard treamtment without additional tape treatment
  intervention type: Other
  intervention name: Kinesio taping
  description: Kinesio tape is a thin, elastic tape that applies pressure to the skin (because of the elasticity of the tape), reducing pain by reducing nociceptive stimulation.
  arm group label: sham tape
  other name: Leukotape K
  other name: medical taping
  intervention type: Other
  intervention name: sham tape (leukotape classic)
  description: leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape
  arm group label: Kinesiotape
  other name: non elastic tape
  intervention type: Other
  intervention name: standard treatment
  description: standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
  arm group label: Kinesiotape
  arm group label: sham tape
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mireille Bakker, MSc
  role: Principal Investigator
  affiliation: OLVG
  last name: Maro Sandel, MD, PhD
  role: Study Chair
  affiliation: OLVG
  last name: Carel Goslings, MD, PhD
  role: Study Chair
  affiliation: OLVG
  last name: Janneke Schuitenmaker, MSc
  role: Study Chair
  affiliation: OLVG
  last name: Mireille Bakker, MSc
  phone: +310205999111
  email: m.e.bakker2@olvg.nl
  last name: Maro Sandel, MD, PhD
  phone: +310205999111
  email: m.sandel@olvg.nl
  responsible party type: Sponsor
  mesh term: Joint Dislocations
  mesh term: Fractures, Bone
  mesh term: Shoulder Fractures
  sharing ipd: No