Kinesiotaping in Trauma

NCT05976256 | Recruiting DMC

• 1 other identifier: WO 21.210
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Rib; Acromioclavicular Joint Dislocation; Fracture Clavicle; Fracture, Proximal Humeral

Keywords

kinesiotaping

Outcome Measures

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).

  1 week

Secondary Outcomes (6)

• number of patients with clinically meaningful pain reduction

  after 15 minutes, 3 weeks and 8 weeks

• evaluating skin defects by questionnaire

  1 week, 3 weeks and 8 weeks

• evaluating use of oral analgesics by questionnaire

  after 1 week, 3 weeks and 8 weeks

• evaluating independence, pattern of activity and course of pain complaints by Groningen Activity Restriction Scale (GARS)

  after 1 week, 3 weeks and 8 weeks

• Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)

  after 15 minutes, 1 week, 3 weeks and 8 weeks

Other Outcomes (1)

• clinical meaningful pain reduction for the different intervention arms

  15 min, 1 week, 3 weeks and 8 weeks

Study Arms (3)

Kinesiotape

ACTIVE COMPARATOR

Patients receives the additional treatment with kinesiotaping (and also standard treament)

Other: sham tape (leukotape classic); Other: standard treatment

sham tape

SHAM COMPARATOR

patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)

Other: Kinesio taping; Other: standard treatment

control group

NO INTERVENTION

patient receives the standard treamtment without additional tape treatment

Interventions

Kinesio taping OTHER

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.

Also known as: Leukotape K, medical taping

sham tape

sham tape (leukotape classic) OTHER

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

Also known as: non elastic tape

Kinesiotape

standard treatment OTHER

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

Kinesiotape; sham tape

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• Patients younger than 18 years
• Incapacitated persons
• Refusal of participation
• Intubation indication
• Decrease of Consciousness
• Hemodynamic instability
• 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

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead
• OLVG: collaborator

Study Sites (1)

Mireille Bakker

Amsterdam, 1090 HM, Netherlands

RECRUITING

MeSH Terms

Conditions

Rib Fractures; Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Shoulder Injuries

Study Officials

• Mireille Bakker, MSc

  OLVG

  PRINCIPAL INVESTIGATOR

• Maro Sandel, MD, PhD

  OLVG

  STUDY CHAIR

• Carel Goslings, MD, PhD

  OLVG

  STUDY CHAIR

• Janneke Schuitenmaker, MSc

  OLVG

  STUDY CHAIR

Central Study Contacts

Mireille Bakker, MSc

CONTACT

+310205999111; m.e.bakker2@olvg.nl

Maro Sandel, MD, PhD

CONTACT

+310205999111; m.sandel@olvg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 4, 2023
• Study Start: December 11, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)