KT Tape for Pediatric Clavicle Fractures

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.

Study Overview

• Status: Recruiting
• Conditions: Clavicle Fracture
• Intervention / Treatment: Device: Arm Sling; Device: KT Tape

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Achraf H Jardaly, BS; Phone Number: 2056176680; Email: ajardaly@uab.edu
• Study Contact Backup: Name: Alice Pennington, RN; Phone Number: 2056389540; Email: alicep@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • Children's Hospital of Alabama
      • Contact: Achraf Jardaly, BS; Phone Number: 205-617-6680; Email: ajardaly@uab.edu
      • Principal Investigator: Shawn R Gilbert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm Sling Group	Device: Arm Sling; An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
Experimental: KT Tape Group	Device: Arm Sling; An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.; Device: KT Tape; in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Shawn R Gilbert, MD, University of Alabama at Birmingham

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: arm sling; Kinesiology tape
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: IRB-300004149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes