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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06031935
Other study ID # STUDY00004289
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2023
Est. completion date January 1, 2025

Study information

Verified date September 2023
Source University of Texas at Austin
Contact Research Coordinator
Phone (512) 478-8116
Email nmcmahon@ctpomd.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - Children with non-structural anterior knee pain Exclusion Criteria: - Any intra-articular injuries - No access to internet - Non-english speaking

Study Design


Intervention

Behavioral:
Yoga
The patients will receive links to two yoga videos. They will do each of these videos at home for 4 weeks.

Locations

Country Name City State
United States Central Texas Pediatric Orthopedics Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 8 weeks
Secondary 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. Log will be recorded weekly for 8 weeks.
Secondary International Knee Documentation Committee (pedi-IKDC) Survey Score Patient Reported Outcome survey. On a scale of 0-100. 100 means knee is fully functional. baseline, 8 weeks and 4 months
Secondary 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. 8 weeks and 4 months
Secondary 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. baseline, 8 weeks and 4 months
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