Clinical trial NCT05976256: Kinesiotaping in Trauma
Official title: Kinesiotaping in Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fracture Rib
Acromioclavicular Joint Dislocation
Fracture Clavicle
Fracture, Proximal Humeral
Keywords: kinesiotaping
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: OLVG
First posted: 2023-08-04
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of patients with clinically meaningful pain reduction
timeFrame: 1 week
Secondary outcomes:
measure: number of patients with clinically meaningful pain reduction
timeFrame: after 15 minutes, 3 weeks and 8 weeks
measure: evaluating skin defects by questionnaire
timeFrame: 1 week, 3 weeks and 8 weeks
measure: evaluating use of oral analgesics by questionnaire
timeFrame: after 1 week, 3 weeks and 8 weeks
measure: evaluating independence, pattern of activity and course of pain complaints by Groningen Activity Restriction Scale (GARS)
timeFrame: after 1 week, 3 weeks and 8 weeks
measure: Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)
timeFrame: after 15 minutes, 1 week, 3 weeks and 8 weeks
measure: Evaluating the need of physiotherapy by questionnaire
timeFrame: 8 weeks
Other outcomes:
measure: clinical meaningful pain reduction for the different intervention arms
timeFrame: 15 min, 1 week, 3 weeks and 8 weeks
Locations:
city: Amsterdam
country: Netherlands
facility: Mireille Bakker
Study officials:
affiliation: OLVG
name: Mireille Bakker, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: OLVG
name: Maro Sandel, MD, PhD
role: STUDY_CHAIR
affiliation: OLVG
name: Carel Goslings, MD, PhD
role: STUDY_CHAIR
affiliation: OLVG
name: Janneke Schuitenmaker, MSc
role: STUDY_CHAIR
References: