- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05976256
Kinesiotaping in Trauma (KIT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mireille Bakker, MSc
- Phone Number: +310205999111
- Email: m.e.bakker2@olvg.nl
Study Contact Backup
- Name: Maro Sandel, MD, PhD
- Phone Number: +310205999111
- Email: m.sandel@olvg.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kinesiotape
Patients receives the additional treatment with kinesiotaping (and also standard treament)
|
leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape
Other Names:
standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
|
Sham Comparator: sham tape
patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)
|
standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
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.
Other Names:
|
No Intervention: control group
patient receives the standard treamtment without additional tape treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients with clinically meaningful pain reduction
Time Frame: 1 week
|
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).
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients with clinically meaningful pain reduction
Time Frame: after 15 minutes, 3 weeks and 8 weeks
|
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).
|
after 15 minutes, 3 weeks and 8 weeks
|
evaluating skin defects by questionnaire
Time Frame: 1 week, 3 weeks and 8 weeks
|
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.
|
1 week, 3 weeks and 8 weeks
|
evaluating use of oral analgesics by questionnaire
Time Frame: after 1 week, 3 weeks and 8 weeks
|
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.
|
after 1 week, 3 weeks and 8 weeks
|
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
|
To delineate the independence, pattern of activity, and course of pain complaints, we employ the Groningen Activity Restriction Scale (GARS).
|
after 1 week, 3 weeks and 8 weeks
|
Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)
Time Frame: after 15 minutes, 1 week, 3 weeks and 8 weeks
|
To gauge comfort and patient satisfaction, the Global Perceived Effect (GPE-DV) is utilized as a measurement tool.
|
after 15 minutes, 1 week, 3 weeks and 8 weeks
|
Evaluating the need of physiotherapy by questionnaire
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical meaningful pain reduction for the different intervention arms
Time Frame: 15 min, 1 week, 3 weeks and 8 weels
|
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)
|
15 min, 1 week, 3 weeks and 8 weels
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mireille Bakker, MSc, OLVG
- Study Chair: Maro Sandel, MD, PhD, OLVG
- Study Chair: Carel Goslings, MD, PhD, OLVG
- Study Chair: Janneke Schuitenmaker, MSc, OLVG
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WO 21.210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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