Kinesiotaping in Trauma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOnze Lieve Vrouwe Gasthuis

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 volunteers

Qualifiers

≥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

Design model

Parallel

Treatments tested in this trial

  • Kinesio taping

    Other intervention

    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.

  • sham tape (leukotape classic)

    Other intervention

    leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape

  • standard treatment

    Other intervention

    standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)

Treatment groups

387 Participants
are divided into 3 treatment groups
Group A: KinesiotapeActive comparator 2 interventions
Group B: sham tapeSham comparator 2 interventions
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
1 week

Secondary outcomes

1

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).

Time frame
after 15 minutes, 3 weeks and 8 weeks
2

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.

Time frame
1 week, 3 weeks and 8 weeks
3

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.

Time frame
after 1 week, 3 weeks and 8 weeks
4

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).

Time frame
after 1 week, 3 weeks and 8 weeks

Other outcomes

1

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)

Time frame
15 min, 1 week, 3 weeks and 8 weeks

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