Clinical trial NCT04161534: KT Tape for Pediatric Clavicle Fractures
Official title: KT Tape Vs Arm Sling for Pediatric Clavicle Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clavicle Fracture
Keywords: arm sling
Kinesiology tape
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Score
timeFrame: Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Secondary outcomes:
measure: Change in Answers to DASH Questionnaire
timeFrame: Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.
measure: Change in Analgesic Use
timeFrame: Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Shawn R Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.