An interventional study of Kinesio taping and sham tape (leukotape classic) in Fracture Rib, Acromioclavicular Joint Dislocation and Fracture Clavicle, sponsored by Onze Lieve Vrouwe Gasthuis. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Onze Lieve Vrouwe Gasthuis · Not applicable, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Rib Fractures; 28 are open to participants now.
This study's planned enrollment of 387 is above the median of 60 across 92 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →Onze Lieve Vrouwe Gasthuis is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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Single shoulder or chest wall injury, which includes one of the following injuries:
Exclusion Criteria:
Patients younger than 18 years
Patients receives the additional treatment with kinesiotaping (and also standard treament)
Other: sham tape (leukotape classic) · Other: standard treatment
patient receives an additional treatment with sham tape (without elastic features) (and also standard treatment)
Other: Kinesio taping · Other: standard treatment
patient receives the standard treamtment without additional tape treatment
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
leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape
Also known as: non elastic tape
standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
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
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
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
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
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
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.
Time frame: after 15 minutes, 1 week, 3 weeks and 8 weeks
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.
Time frame: 8 weeks
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
Plan to share: No
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Started Dec 2023 (actual). Primary completion is estimated for Dec 2025, 24 months after the start.
Of 40 non-industry interventional studies with no phase under Rib Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 24 months is close to that.
Counting every sponsor, half of 40 studies reached it within 23 months; a quarter within 15 and three quarters within 37.
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Onze Lieve Vrouwe Gasthuis