KT Tape for Pediatric Clavicle Fractures

NCT ID: NCT04161534

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Clavicle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm Sling Group

Group Type ACTIVE_COMPARATOR

Arm Sling

Intervention Type DEVICE

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

KT Tape Group

Group Type EXPERIMENTAL

KT Tape

Intervention Type DEVICE

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

Arm Sling

Intervention Type DEVICE

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

Interventions

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KT Tape

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

Intervention Type DEVICE

Arm Sling

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Shawn Gilbert

Professor, Chief of Pediatric Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shawn R Gilbert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Achraf H Jardaly, BS

Role: CONTACT

2056176680

Alice Pennington, RN

Role: CONTACT

2056389540

Facility Contacts

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Achraf Jardaly, BS

Role: primary

2056176680

Shawn R Gilbert, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26530661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30134883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20443039 (View on PubMed)

Other Identifiers

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IRB-300004149

Identifier Type: -

Identifier Source: org_study_id

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