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Kinesiotaping in Trauma (KIT)

Primary Purpose

Fracture Rib, Acromioclavicular Joint Dislocation, Fracture Clavicle

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesio taping
sham tape (leukotape classic)
standard treatment
Sponsored by
Onze Lieve Vrouwe Gasthuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Rib focused on measuring kinesiotaping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ≥18 years Acute injury (occurred <24 hours ago) Single shoulder or chest wall injury, which includes one of the following injuries: rib fracture disruption of the AC-joint Tossy type 1 and 2 not or hardly dislocated fracture of the clavicle Not or hardly dislocated fracture of the r proximal humeral fracture Exclusion Criteria: • Patients younger than 18 years Incapacitated persons Refusal of participation Intubation indication Decrease of Consciousness Hemodynamic instability 3 or more rib fractures Rib fracture rib 1-3 Indication for surgery Hospitalization required Presence of a haemo- or pneumothorax with chest drain indication Already known with allergy for adhesive tape Patients with very thin or loose skin on the applicable body part Skin infection/irritation or open wound on the applicable body part Patients who do not speak Dutch or English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Sham Comparator

    No Intervention

    Arm Label

    Kinesiotape

    sham tape

    control group

    Arm Description

    Patients receives the additional treatment with kinesiotaping (and also standard treament)

    patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)

    patient receives the standard treamtment without additional tape treatment

    Outcomes

    Primary Outcome Measures

    number of patients with clinically meaningful pain reduction
    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).

    Secondary Outcome Measures

    number of patients with clinically meaningful pain reduction
    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).
    evaluating skin defects by questionnaire
    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.
    evaluating use of oral analgesics by questionnaire
    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.
    evaluating independence, pattern of activity and course of pain complaints by Groningen Activity Restriction Scale (GARS)
    To delineate the independence, pattern of activity, and course of pain complaints, we employ the Groningen Activity Restriction Scale (GARS).
    Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)
    To gauge comfort and patient satisfaction, the Global Perceived Effect (GPE-DV) is utilized as a measurement tool.
    Evaluating the need of physiotherapy by questionnaire
    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.

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    July 27, 2023
    Sponsor
    Onze Lieve Vrouwe Gasthuis
    Collaborators
    OLVG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05976256
    Brief Title
    Kinesiotaping in Trauma
    Acronym
    KIT
    Official Title
    Kinesiotaping in Trauma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Onze Lieve Vrouwe Gasthuis
    Collaborators
    OLVG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fracture Rib, Acromioclavicular Joint Dislocation, Fracture Clavicle, Fracture, Proximal Humeral
    Keywords
    kinesiotaping

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    RCT
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    387 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesiotape
    Arm Type
    Active Comparator
    Arm Description
    Patients receives the additional treatment with kinesiotaping (and also standard treament)
    Arm Title
    sham tape
    Arm Type
    Sham Comparator
    Arm Description
    patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    patient receives the standard treamtment without additional tape treatment
    Intervention Type
    Other
    Intervention Name(s)
    Kinesio taping
    Other Intervention Name(s)
    Leukotape K, medical taping
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    sham tape (leukotape classic)
    Other Intervention Name(s)
    non elastic tape
    Intervention Description
    leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape
    Intervention Type
    Other
    Intervention Name(s)
    standard treatment
    Intervention Description
    standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
    Primary Outcome Measure Information:
    Title
    number of patients with clinically meaningful pain reduction
    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).
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    number of patients with clinically meaningful pain reduction
    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).
    Time Frame
    after 15 minutes, 3 weeks and 8 weeks
    Title
    evaluating skin defects by questionnaire
    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.
    Time Frame
    1 week, 3 weeks and 8 weeks
    Title
    evaluating use of oral analgesics by questionnaire
    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.
    Time Frame
    after 1 week, 3 weeks and 8 weeks
    Title
    evaluating independence, pattern of activity and course of pain complaints by Groningen Activity Restriction Scale (GARS)
    Description
    To delineate the independence, pattern of activity, and course of pain complaints, we employ the Groningen Activity Restriction Scale (GARS).
    Time Frame
    after 1 week, 3 weeks and 8 weeks
    Title
    Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)
    Description
    To gauge comfort and patient satisfaction, the Global Perceived Effect (GPE-DV) is utilized as a measurement tool.
    Time Frame
    after 15 minutes, 1 week, 3 weeks and 8 weeks
    Title
    Evaluating the need of physiotherapy by questionnaire
    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.
    Time Frame
    8 weeks
    Other Pre-specified Outcome Measures:
    Title
    clinical meaningful pain reduction for the different intervention arms
    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)
    Time Frame
    15 min, 1 week, 3 weeks and 8 weels

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ≥18 years Acute injury (occurred <24 hours ago) Single shoulder or chest wall injury, which includes one of the following injuries: rib fracture disruption of the AC-joint Tossy type 1 and 2 not or hardly dislocated fracture of the clavicle Not or hardly dislocated fracture of the r proximal humeral fracture Exclusion Criteria: • Patients younger than 18 years Incapacitated persons Refusal of participation Intubation indication Decrease of Consciousness Hemodynamic instability 3 or more rib fractures Rib fracture rib 1-3 Indication for surgery Hospitalization required Presence of a haemo- or pneumothorax with chest drain indication Already known with allergy for adhesive tape Patients with very thin or loose skin on the applicable body part Skin infection/irritation or open wound on the applicable body part Patients who do not speak Dutch or English
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mireille Bakker, MSc
    Phone
    +310205999111
    Email
    m.e.bakker2@olvg.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maro Sandel, MD, PhD
    Phone
    +310205999111
    Email
    m.sandel@olvg.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mireille Bakker, MSc
    Organizational Affiliation
    OLVG
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Maro Sandel, MD, PhD
    Organizational Affiliation
    OLVG
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Carel Goslings, MD, PhD
    Organizational Affiliation
    OLVG
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Janneke Schuitenmaker, MSc
    Organizational Affiliation
    OLVG
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Kinesiotaping in Trauma

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