Fracture RibKITNCT05976256
Kinesiotaping in Trauma
A study testing Kinesio taping and standard treatment in people with Fracture Rib and Acromioclavicular Joint Dislocation, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture Rib, Acromioclavicular Joint Dislocation, Fracture Clavicle
- What is being tested?
- Kinesio taping and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Dec 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- • Patients younger than 18 years
- Incapacitated persons
- Refusal of participation
- Intubation indication
- Decrease of Consciousness
- Hemodynamic instability
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Mireille Bakker
Amsterdam, 1090 HM
Mireille Bakker, +31610978189, m.e.bakker2@olvg.nl
About this study
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.
Read the 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.
- Conditions
- Fracture Rib, Acromioclavicular Joint Dislocation, Fracture Clavicle, Fracture, Proximal Humeral
- Being tested
- Kinesio taping, sham tape (leukotape classic), standard treatment
- Keywords
- kinesiotaping
- Medical subject headings
- Rib Fractures, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
Also called Leukotape K, medical taping
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
Also called non elastic tape
leuko tape classic is used in this study to explore the possible placebo effect of kinesiotape
standard treatmentOther
standard treatment is the treatment with oral analgesics and a sling (if shoulder injury)
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Active comparator | Patients receives the additional treatment with kinesiotaping (and also standard treament) Receives: 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) Receives: Other: Kinesio taping; Other: standard treatment |
| control group | No intervention | patient receives the standard treamtment without additional tape treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start11 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture RibStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- OLVG
- Responsible party
- Sponsor
- Investigators
- Mireille Bakker, MSc, Principal investigator, OLVGMaro Sandel, MD, PhD, Study chair, OLVGCarel Goslings, MD, PhD, Study chair, OLVGJanneke Schuitenmaker, MSc, Study chair, OLVG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976256
- Sponsor's protocol ID
- WO 21.210
- Acronym
- KIT
- Status last verified
- Apr 2025
- First submitted
- 17 Jul 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiotaping in Trauma
- ClinicalTrials.gov ID
- NCT05976256
- Acronym / sponsor ID
- KIT / WO 21.210
- Conditions
- Fracture Rib, Acromioclavicular Joint Dislocation, Fracture Clavicle, Fracture, Proximal Humeral
- Keywords
- kinesiotaping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- OLVG
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Active comparator | Other: sham tape (leukotape classic), Other: standard treatmentPatients receives the additional treatment with kinesiotaping (and also standard treament) |
| sham tape | Sham comparator | Other: Kinesio taping, Other: standard treatmentpatient receives an additional treatment with sham tape (without elastic features) (and also standard treatment) |
| control group | No intervention | –patient receives the standard treamtment without additional tape treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years
- Acute injury (occurred <24 hours ago)
- Single shoulder or chest wall injury, which includes one of the following injuries:
Key exclusion criteria (15 listed)
- • Patients younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapingAlso: Leukotape K, medical tapingKinesio 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. | Other | sham tape |
| sham tape (leukotape classic)Also: non elastic tapeleuko tape classic is used in this study to explore the possible placebo effect of kinesiotape | Other | Kinesiotape |
| standard treatmentstandard treatment is the treatment with oral analgesics and a sling (if shoulder injury) | Other | Kinesiotape, sham tape |
Primary outcome
number of patients with clinically meaningful pain reduction
Time frame: 1 week
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).
6 secondary outcomes
number of patients with clinically meaningful pain reduction
Time frame: after 15 minutes, 3 weeks and 8 weeks
evaluating skin defects by questionnaire
Time frame: 1 week, 3 weeks and 8 weeks
evaluating use of oral analgesics by questionnaire
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)
Time frame: after 1 week, 3 weeks and 8 weeks
Evaluating comfort and patient satisfaction by Global Perceived Effect (GPE-DV)
Time frame: after 15 minutes, 1 week, 3 weeks and 8 weeks
Evaluating the need of physiotherapy by questionnaire
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mireille Bakker, MSc principal investigator
OLVG
Maro Sandel, MD, PhD study chair
OLVG
Carel Goslings, MD, PhD study chair
OLVG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and standard treatment in people with Fracture Rib and Acromioclavicular Joint Dislocation, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireille Bakker, MSc (+310205999111, m.e.bakker2@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with clinically meaningful pain reduction (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.