Acromioclavicular Joint Dislocation Clinical Trial
— KITOfficial title:
Kinesiotaping in Trauma
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.
Status | Not yet recruiting |
Enrollment | 387 |
Est. completion date | December 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Onze Lieve Vrouwe Gasthuis | OLVG |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | clinical meaningful pain reduction for the different intervention arms | 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 | |
Primary | 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). | 1 week | |
Secondary | 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). | after 15 minutes, 3 weeks and 8 weeks | |
Secondary | 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. | 1 week, 3 weeks and 8 weeks | |
Secondary | 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. | after 1 week, 3 weeks and 8 weeks | |
Secondary | 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). | after 1 week, 3 weeks and 8 weeks | |
Secondary | 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. | after 15 minutes, 1 week, 3 weeks and 8 weeks | |
Secondary | 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. | 8 weeks |
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