KT Tape for Pediatric Clavicle Fractures

Clavicle Fracture Clinical Trial

Official title:

KT Tape vs Arm Sling for Pediatric Clavicle Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161534
• Other study ID #: IRB-300004149
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Achraf H Jardaly, BS
• Phone: 2056176680
• Email: ajardaly[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Clavicle Fracture
• Injury date within 1 week of presentation

Exclusion Criteria:

• Underlying neuromuscular disorder (eg osteogenesis imperfecta)
• Inability or unwillingness to report pain score until healing

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Device:
• KT Tape
in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
• Arm Sling
An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Kaya 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. — View Citation

Reynard 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Score	Participants will rate their pain on a scale from 1 to 10	Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Secondary	Change in Answers to DASH Questionnaire	Participants will complete the DASH questionnaire to assess disability they might be experiencing due to their fracture.	Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.
Secondary	Change in Analgesic Use	Participants will provide the need for taking analgesics (name, dose, and frequency).	Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury