A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
Primary Purpose
Patellar Tendinitis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesio Tape
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Tendinitis
Eligibility Criteria
Inclusion Criteria:
- score of less than 80 on the Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P)
- experienced patellar tendon pain for greater than 14 days
- tender to palpation at the patellar tendon.
Exclusion Criteria:
- knee surgery in the last six months
- acute injury to the knee
- any pain in the ankles, hips or core that may compromise balance testing
- any allergy to adhesive
- malignancies
- cellulitis
- skin infection
- diabetes
- fragile skin
Sites / Locations
- North Dakota State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Hip
Knee
Hip and Knee
Arm Description
Gluteus medius facilitation tape
Patellar sling tape
Gluteus medius facilitation and patellar sling tape
Outcomes
Primary Outcome Measures
Tampa Scale for Kinesiophobia
Measures fear of movement, score range 17-68, higher score means higher degree of kinesiophobia
Visual Analog Scale
Measures overall pain, score range 1-10, higher score indicates more pain
Biodex Balance System
Measures balance
Secondary Outcome Measures
Full Information
NCT ID
NCT04219917
First Posted
January 3, 2020
Last Updated
February 25, 2020
Sponsor
North Dakota State University
1. Study Identification
Unique Protocol Identification Number
NCT04219917
Brief Title
A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
Official Title
A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Dakota State University
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
The purpose of this study is to explore the possible effects Kinesio Tape may have on proprioception in individuals with patellar tendonitis. A supportive knee application, a facilitative hip application, and a combination of the two will be applied and compared. Within and between group comparisons will be drawn.
Participants will report for two research sessions with 24-36 hours between. Prior to arrival, they will complete a digital Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P) and email it to the researcher. Participants must score less than 80 (out of a possible 100) to be considered for this study. If the individual meets the inclusion criteria, he/she will be scheduled for the 1st session. Upon arrival to the first session, informed consent will be obtained, the VISA-P will be reviewed, and intance of patellar tendonitis will be confirmed through palpation. Participants will then completed a Tampa Scale for Kinesiophobia (TSK) to measure fear of movement and a Visual Analog Scale (VAS) to measure overall pain. Height and weight measurments will be taken due to requirements of the Biodex Balance System (BBS), which will be used for balance measurements. Participants will take two, twenty-second practice tests, one with eyes open and one with eyes closed, followed by two minutes rest. Baseline testing will then be completed as follows: the participant will complete two tests with eyes open, and two tests with eyes closed on the injured leg, each with one minute rest between. The participant will then be taped with Kinesio Tape to either the hip, knee, or both the hip and knee according to the random group assignment. They will then rest for 15 minutes and complete a second round of balance testing with the same parameters as baseline testing. Participants will be scheduled for a second day no less that 24 hours and no more than 36 hours for re-test purposes.
On the second day of testing, participants will be given $10 for their participation on Day 1. If they want to continue with testing procedures, they will participate in the same balance testing procedures as Day 1. The integrety of the tape application will be confirmed, and second TSK and VAS scale will be administered. A final round of balance testing will be completed, and the participant will receive an additional $10 if they choose to complete both days of testing.
This research will allow us to compare results of the TSK, the VAS and the BBS testing both within subject and between group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hip
Arm Type
Experimental
Arm Description
Gluteus medius facilitation tape
Arm Title
Knee
Arm Type
Experimental
Arm Description
Patellar sling tape
Arm Title
Hip and Knee
Arm Type
Experimental
Arm Description
Gluteus medius facilitation and patellar sling tape
Intervention Type
Other
Intervention Name(s)
Kinesio Tape
Intervention Description
Kinesio Tape will be applied to treat the pain associated with patellar tendonitis, to treat the cause of the pain, and to treat both factors.
Primary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia
Description
Measures fear of movement, score range 17-68, higher score means higher degree of kinesiophobia
Time Frame
24 hours
Title
Visual Analog Scale
Description
Measures overall pain, score range 1-10, higher score indicates more pain
Time Frame
24 hours
Title
Biodex Balance System
Description
Measures balance
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
score of less than 80 on the Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P)
experienced patellar tendon pain for greater than 14 days
tender to palpation at the patellar tendon.
Exclusion Criteria:
knee surgery in the last six months
acute injury to the knee
any pain in the ankles, hips or core that may compromise balance testing
any allergy to adhesive
malignancies
cellulitis
skin infection
diabetes
fragile skin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Lyman, PhD
Phone
701-231-8208
Email
katie.lyman@ndsu.edu
Facility Information:
Facility Name
North Dakota State University
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy Shirley
Phone
701-231-8995
Email
kristy.shirley@ndsu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
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