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Kinesiotaping Therapy for Clavicular Fractures FRACTURES:

Primary Purpose

Clavicle Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping therapy
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture focused on measuring kinesiotherapy, arm sling

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants with midclavicle fracture within 24 hours

Exclusion Criteria:

Participants with open fractures,

Sites / Locations

  • SBU Prof. Cemil Tascioglu City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm sling only group (group S)

Arm sling with kinesiotaping therapy group (group K).

Arm Description

Participants used only arm sling for clavicula fracture

Participants used arm sling and the investigators applied kinesiotheraphy for clavicula fracture

Outcomes

Primary Outcome Measures

Comparison of the two groups in terms of early return to work
The investigators aim is to examine the effect of kinesiotaping treatment on clavicle fracture union.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
November 4, 2020
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04622137
Brief Title
Kinesiotaping Therapy for Clavicular Fractures FRACTURES:
Official Title
An Alternative Conservative Treatment Method For Midshaft Clavicular Fractures: Kinesiotaping Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a multicenter prospective randomized controlled study. Forty patients in whom conservative treatment for clavicle midshaft fractures was indicated between January 2018 and July 2019 were included. The investigators aimed to evaluate the effectiveness of the kinesiotaping technique for the conservative treatment of clavicle midshaft fractures. The investigators hypothesized that kinesiotaping reduces the disadvantages of conservative treatment, such as early-phase pain, high nonunion rates, and a prolonged time to return to work, and yields better clinical and functional outcomes by providing good mechanical support and neutralizing the deforming muscle forces around the fractured clavicle.
Detailed Description
The investigators divided into 2 groups and followed one group of patients with clavicle fractures only with shoulder sling, while the other group were followed with kinesiotherapy treatment and shoulder arm sling. They investigated the effect of kinesiotherapy treatment on early pain and returning time to work.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm sling only group (group S)
Arm Type
No Intervention
Arm Description
Participants used only arm sling for clavicula fracture
Arm Title
Arm sling with kinesiotaping therapy group (group K).
Arm Type
Active Comparator
Arm Description
Participants used arm sling and the investigators applied kinesiotheraphy for clavicula fracture
Intervention Type
Procedure
Intervention Name(s)
Kinesiotaping therapy
Intervention Description
The investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula.
Primary Outcome Measure Information:
Title
Comparison of the two groups in terms of early return to work
Description
The investigators aim is to examine the effect of kinesiotaping treatment on clavicle fracture union.
Time Frame
6. months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with midclavicle fracture within 24 hours Exclusion Criteria: Participants with open fractures,
Facility Information:
Facility Name
SBU Prof. Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34040
Country
Turkey

12. IPD Sharing Statement

Citations:
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Citation
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Kinesiotaping Therapy for Clavicular Fractures FRACTURES:

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