Clavicle FractureNCT04161534
KT Tape for Pediatric Clavicle Fractures
A study testing KT Tape and Arm Sling in people with Clavicle Fracture, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- KT Tape and Arm Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Oct 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clavicle Fracture
- Injury date within 1 week of presentation
Who cannot join
- Underlying neuromuscular disorder (eg osteogenesis imperfecta)
- Inability or unwillingness to report pain score until healing
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Alabama
Birmingham, Alabama, 35233
About this study
Official title: KT Tape vs Arm Sling for Pediatric Clavicle Fractures
Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling.
There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.
- Conditions
- Clavicle Fracture
- Being tested
- KT Tape, Arm Sling
- Keywords
- arm sling, Kinesiology tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT TapeDevice
in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
Arm SlingDevice
An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
| Study group | Role | What they receive |
|---|---|---|
| Arm Sling Group | Active comparator | Not described Receives: Device: Arm Sling |
| KT Tape Group | Experimental | Not described Receives: Device: KT Tape; Device: Arm Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Participants will rate their pain on a scale from 1 to 10
Measured: Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Secondary outcomes (2)
Change in Answers to DASH Questionnaire
Participants will complete the DASH questionnaire to assess disability they might be experiencing due to their fracture.
Measured: Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.
Change in Analgesic Use
Participants will provide the need for taking analgesics (name, dose, and frequency).
Measured: Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Oct 2020
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn Gilbert, University of Alabama at Birmingham
- Investigators
- Shawn R Gilbert, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161534
- Sponsor's protocol ID
- IRB-300004149
- Other IDs
- UAB
- Status last verified
- Mar 2026
- First submitted
- 11 Oct 2019
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ersen A, Atalar AC, Birisik F, Saglam Y, Demirhan M. Comparison of simple arm sling and figure of eight clavicular bandage for midshaft clavicular fractures: a randomised controlled study. Bone Joint J. 2015 Nov;97-B(11):1562-5. doi: 10.1302/0301-620X.97B11.35588.
PubMed 26530661Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.
PubMed 30134883Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clin Rheumatol. 2011 Feb;30(2):201-7. doi: 10.1007/s10067-010-1475-6. Epub 2010 Apr 30.
PubMed 20443039
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KT Tape vs Arm Sling for Pediatric Clavicle Fractures
- ClinicalTrials.gov ID
- NCT04161534
- Acronym / sponsor ID
- IRB-300004149
- Conditions
- Clavicle Fracture
- Keywords
- arm sling, Kinesiology tape
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Nov 2019 (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.
Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling.
There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)
| Arm | Type | Receives |
|---|---|---|
| Arm Sling Group | Active comparator | Device: Arm Sling |
| KT Tape Group | Experimental | Device: KT Tape, Device: Arm Sling |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clavicle Fracture
- Injury date within 1 week of presentation
Key exclusion criteria (2 listed)
- Underlying neuromuscular disorder (eg osteogenesis imperfecta)
- Inability or unwillingness to report pain score until healing
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 |
|---|---|---|
| KT Tapein addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain. | Device | KT Tape Group |
| Arm SlingAn arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain. | Device | Arm Sling Group, KT Tape Group |
Primary outcome
Change in Pain Score
Time frame: Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Participants will rate their pain on a scale from 1 to 10
2 secondary outcomes
Change in Answers to DASH Questionnaire
Time frame: Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.
Change in Analgesic Use
Time frame: Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury
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 2 Apr 2026.
- Background: PubMed 26530661Ersen A, Atalar AC, Birisik F, Saglam Y, Demirhan M. Comparison of simple arm sling and figure of eight clavicular bandage for midshaft clavicular fractures: a randomised controlled study. Bone Joint J. 2015 Nov;97-B(11):1562-5. doi: 10.1302/0301-620X.97B11.35588.
- Background: PubMed 30134883Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.
- Background: PubMed 20443039Kaya E, Zinnuroglu M, Tugcu I. Kinesio taping compared to physical therapy modalities for the treatment of shoulder impingement syndrome. Clin Rheumatol. 2011 Feb;30(2):201-7. doi: 10.1007/s10067-010-1475-6. Epub 2010 Apr 30.
- 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. This study is not recruiting at the moment.
Shawn R Gilbert, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KT Tape and Arm Sling in people with Clavicle Fracture, run by University of Alabama at Birmingham at 1 site in United States.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. 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 United States. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161534, which also lists 3 linked publications.
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 2 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.