About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 years
Acute injury (occurred <24 hours ago)
rib fracture
disruption of the AC-joint Tossy type 1 and 2
Disqualifiers
• Patients younger than 18 years
Incapacitated persons
Refusal of participation
Intubation indication
Trial design
Parallel
Treatments tested in this trial
Kinesio taping
Other interventionKinesio 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.
sham tape (leukotape classic)
Other interventionleuko tape classic is used in this study to explore the possible placebo effect of kinesiotape
standard treatment
Other interventionstandard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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).
Other outcomes
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)
Sponsors and contacts
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Onze Lieve Vrouwe Gasthuis
Lead sponsor
OLVG
Collaborator