KT Tape for Pediatric Clavicle Fractures

NCT04161534 | Active Not Recruiting FDA Device

• 2 other identifiers: IRB-300004149UAB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture

Keywords

arm sling; Kinesiology tape

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Answers to DASH Questionnaire

  Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.

• Change in Analgesic Use

  Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury

Study Arms (2)

Arm Sling Group

ACTIVE COMPARATOR

Device: Arm Sling

KT Tape Group

EXPERIMENTAL

Device: KT Tape; Device: Arm Sling

Interventions

KT Tape DEVICE

in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.

KT Tape Group

Arm Sling DEVICE

An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.

Arm Sling Group; KT Tape Group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clavicle Fracture
• Injury date within 1 week of presentation

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Related 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.

  PMID: 26530661 BACKGROUND

• 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.

  PMID: 30134883 BACKGROUND

• 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.

  PMID: 20443039 BACKGROUND

Study Officials

• Shawn R Gilbert, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Pediatric Orthopaedics

Model Details: Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: November 13, 2019
• Study Start: October 1, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)