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KT Tape for Pediatric Clavicle Fractures

Primary Purpose

Clavicle Fracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KT Tape
Arm Sling
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Clavicle Fracture focused on measuring arm sling, Kinesiology tape

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of AlabamaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Sling Group

KT Tape Group

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain Score
Participants will rate their pain on a scale from 1 to 10

Secondary Outcome Measures

Change in Answers to DASH Questionnaire
Participants will complete the DASH questionnaire to assess disability they might be experiencing due to their fracture.
Change in Analgesic Use
Participants will provide the need for taking analgesics (name, dose, and frequency).

Full Information

First Posted
October 11, 2019
Last Updated
October 20, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04161534
Brief Title
KT Tape for Pediatric Clavicle Fractures
Official Title
KT Tape vs Arm Sling for Pediatric Clavicle Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture
Keywords
arm sling, Kinesiology tape

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be treated with an arm sling and will be randomized to kinesio tape (KT Tape) or no kinesio tape (control)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm Sling Group
Arm Type
Active Comparator
Arm Title
KT Tape Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
KT Tape
Intervention Description
in addition to an arm sling, KT Tape will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
Intervention Type
Device
Intervention Name(s)
Arm Sling
Intervention Description
An arm sling will be applied to stabilize the clavicle fracture, thereby decreasing motion and pain.
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
Participants will rate their pain on a scale from 1 to 10
Time Frame
Twice daily for 3 weeks, and one additional time 6 weeks after the initial injnury
Secondary Outcome Measure Information:
Title
Change in Answers to DASH Questionnaire
Description
Participants will complete the DASH questionnaire to assess disability they might be experiencing due to their fracture.
Time Frame
Once weekly for 3 weeks, followed by one additional time 6 weeks after the initial injury.
Title
Change in Analgesic Use
Description
Participants will provide the need for taking analgesics (name, dose, and frequency).
Time Frame
Once daily for 3 weeks, and one additional time 6 weeks after the initial injnury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Achraf H Jardaly, BS
Phone
2056176680
Email
ajardaly@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Pennington, RN
Phone
2056389540
Email
alicep@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn R Gilbert, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achraf Jardaly, BS
Phone
205-617-6680
Email
ajardaly@uab.edu
First Name & Middle Initial & Last Name & Degree
Shawn R Gilbert, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26530661
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.
Results Reference
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PubMed Identifier
30134883
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.
Results Reference
background
PubMed Identifier
20443039
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.
Results Reference
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KT Tape for Pediatric Clavicle Fractures

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