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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04161534
Other study ID # IRB-300004149
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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