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A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis

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ClinicalTrials.gov Identifier: NCT04219917
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
North Dakota State University

Tracking Information
First Submitted Date  ICMJE January 3, 2020
First Posted Date  ICMJE January 7, 2020
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE December 20, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
  • Tampa Scale for Kinesiophobia [ Time Frame: 24 hours ]
    Measures fear of movement, score range 17-68, higher score means higher degree of kinesiophobia
  • Visual Analog Scale [ Time Frame: 24 hours ]
    Measures overall pain, score range 1-10, higher score indicates more pain
  • Biodex Balance System [ Time Frame: 24 hours ]
    Measures balance
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
  • Tampa Scale for Kinesiophobia [ Time Frame: 24 hours ]
    Measures fear of movement
  • Visual Analog Scale [ Time Frame: 24 hours ]
    Measures overall pain
  • Biodex Balance System [ Time Frame: 24 hours ]
    Measures balance
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
Official Title  ICMJE A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patellar Tendinitis
Intervention  ICMJE Other: Kinesio Tape
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.
Study Arms  ICMJE
  • Experimental: Hip
    Gluteus medius facilitation tape
    Intervention: Other: Kinesio Tape
  • Experimental: Knee
    Patellar sling tape
    Intervention: Other: Kinesio Tape
  • Experimental: Hip and Knee
    Gluteus medius facilitation and patellar sling tape
    Intervention: Other: Kinesio Tape
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Katie Lyman, PhD 701-231-8208 katie.lyman@ndsu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04219917
Other Study ID Numbers  ICMJE HE20097
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party North Dakota State University
Study Sponsor  ICMJE North Dakota State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account North Dakota State University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP