Yoga for Adolescent Knee Pain
Primary Purpose
Anterior Knee Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Knee Pain Syndrome focused on measuring Adolescent
Eligibility Criteria
Inclusion Criteria: Children with non-structural anterior knee pain Exclusion Criteria: Any intra-articular injuries No access to internet Non-english speaking
Sites / Locations
- Central Texas Pediatric OrthopedicsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga study group
Arm Description
This is the only arm of the study. The patients will be given yoga videos to do at home for 8 weeks as a treatment for anterior knee pain.
Outcomes
Primary Outcome Measures
Patient Flexibility
Popliteal angle to test hamstring flexibility. On a scale of 0-90. A popliteal angle of 90 would mean very tight hamstrings. Prone heel to buttocks measurement will be taken to determine how close the patient can get their heel to buttocks. It will be measured in inches. A larger measurement means less flexibility. 0" is an ideal measurement.
Secondary Outcome Measures
Number of views of yoga videos
Patient will keep a log of the number of times they do the videos, and we will use YouTube analytics to confirm the number of views.
International Knee Documentation Committee (pedi-IKDC) Survey Score
Patient Reported Outcome survey. On a scale of 0-100. 100 means knee is fully functional.
Yoga video satisfaction survey
Satisfaction questions as defined by study team on a scale of 0-5. To determine if the yoga videos were useful to the patients.
Patient-Reported Outcomes Measurement Information Systems (PROMIS) pain interference scale
Measures the extent that pain is interfering with the patient's daily lifestyle. Pain is measured on a T-scale. 50 is the median. 20-55 is considered within the normal limits. 70+ is severe.
Full Information
NCT ID
NCT06031935
First Posted
August 23, 2023
Last Updated
September 7, 2023
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT06031935
Brief Title
Yoga for Adolescent Knee Pain
Official Title
Yoga for Adolescent Anterior Knee Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is currently managed with home exercises and physical therapy. The goal of this project is to present patients with an alternative treatment in the form of yoga available in an online video format. This new treatment, in the form of online yoga videos, may be more preferred for some patients and allow for higher compliance with home exercises aimed at treating anterior knee pain.
Detailed Description
Adolescent atraumatic anterior knee pain is a common yet cumbersome diagnosis that is currently managed with home exercises and physical therapy. The goal of this project is to test the compliance and efficacy of an alternative treatment in the form of yoga available in an online video format. This study will help further the treatment understanding of one of the most common patient clinical presentations, atraumatic anterior knee pain in adolescents. This is a cumbersome patient presentation that is frustrating for both the patient and treating team in that there is no concrete treatment algorithm that works for everyone. Online yoga videos may be more preferred for some patients and allow for higher compliance with home exercises aimed at treating anterior knee pain. With this study, the investigators hope to ensure that the yoga videos provide equal, or more, pain relief and flexibility at the completion of the program.
It is hypothesized that patients completing the yoga program will have equivalent or greater flexibility, compliance, and pain relief when compared with current treatment recommendations for anterior knee pain.
This study aims to assess the success of a video-based eight-week home yoga program at improving compliance, increasing flexibility and functionality of knee movements. Compliance will be tracked through recorded access to the specific YouTube videos hosted through the CTPO YouTube Channel. Anterior knee pain patients will be given a link to two yoga videos and will be asked to do them at home, or wherever convenient for 8 weeks, 3-4 times a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Knee Pain Syndrome
Keywords
Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yoga study group
Arm Type
Experimental
Arm Description
This is the only arm of the study. The patients will be given yoga videos to do at home for 8 weeks as a treatment for anterior knee pain.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
The patients will receive links to two yoga videos. They will do each of these videos at home for 4 weeks.
Primary Outcome Measure Information:
Title
Patient Flexibility
Description
Popliteal angle to test hamstring flexibility. On a scale of 0-90. A popliteal angle of 90 would mean very tight hamstrings. Prone heel to buttocks measurement will be taken to determine how close the patient can get their heel to buttocks. It will be measured in inches. A larger measurement means less flexibility. 0" is an ideal measurement.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Number of views of yoga videos
Description
Patient will keep a log of the number of times they do the videos, and we will use YouTube analytics to confirm the number of views.
Time Frame
Log will be recorded weekly for 8 weeks.
Title
International Knee Documentation Committee (pedi-IKDC) Survey Score
Description
Patient Reported Outcome survey. On a scale of 0-100. 100 means knee is fully functional.
Time Frame
baseline, 8 weeks and 4 months
Title
Yoga video satisfaction survey
Description
Satisfaction questions as defined by study team on a scale of 0-5. To determine if the yoga videos were useful to the patients.
Time Frame
8 weeks and 4 months
Title
Patient-Reported Outcomes Measurement Information Systems (PROMIS) pain interference scale
Description
Measures the extent that pain is interfering with the patient's daily lifestyle. Pain is measured on a T-scale. 50 is the median. 20-55 is considered within the normal limits. 70+ is severe.
Time Frame
baseline, 8 weeks and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with non-structural anterior knee pain
Exclusion Criteria:
Any intra-articular injuries
No access to internet
Non-english speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
(512) 478-8116
Email
nmcmahon@ctpomd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Ellington, MD
Organizational Affiliation
University of Texas at Austin, Central Texas Pediatric Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Texas Pediatric Orthopedics
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew D Ellington, MD
Phone
512-478-8116
Email
mellington@ctpomd.com
First Name & Middle Initial & Last Name & Degree
Niamh D McMahon, MS
Phone
5124788116
Email
nmcmahon@ctpomd.com
First Name & Middle Initial & Last Name & Degree
Matthew D Ellington, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared outside of the study team.
Citations:
PubMed Identifier
18300936
Citation
Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208.
Results Reference
background
PubMed Identifier
16371493
Citation
Donohue B, Miller A, Beisecker M, Houser D, Valdez R, Tiller S, Taymar T. Effects of brief yoga exercises and motivational preparatory interventions in distance runners: results of a controlled trial. Br J Sports Med. 2006 Jan;40(1):60-3; discussion 60-3. doi: 10.1136/bjsm.2005.020024.
Results Reference
background
PubMed Identifier
29973555
Citation
Hainsworth KR, Liu XC, Simpson PM, Swartz AM, Linneman N, Tran ST, Medrano GR, Mascarenhas B, Zhang L, Weisman SJ. A Pilot Study of Iyengar Yoga for Pediatric Obesity: Effects on Gait and Emotional Functioning. Children (Basel). 2018 Jul 4;5(7):92. doi: 10.3390/children5070092.
Results Reference
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Yoga for Adolescent Knee Pain
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