NCT06031935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

August 23, 2023

Last Update Submit

September 7, 2023

Conditions

Anterior Knee Pain Syndrome

Keywords

Adolescent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of views of yoga videos

    Log will be recorded weekly for 8 weeks.

  • International Knee Documentation Committee (pedi-IKDC) Survey Score

    baseline, 8 weeks and 4 months

  • Yoga video satisfaction survey

    8 weeks and 4 months

  • Patient-Reported Outcomes Measurement Information Systems (PROMIS) pain interference scale

    baseline, 8 weeks and 4 months

Study Arms (1)

Yoga study group

EXPERIMENTAL

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.

Behavioral: Yoga

Interventions

YogaBEHAVIORAL

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

Yoga study group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with non-structural anterior knee pain

You may not qualify if:

  • Any intra-articular injuries
  • No access to internet
  • Non-english speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Texas Pediatric Orthopedics

Austin, Texas, 78723, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18300936BACKGROUND

  • 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.

    PMID: 16371493BACKGROUND

  • 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.

    PMID: 29973555BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Yoga

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Matthew D Ellington, MD

    University of Texas at Austin, Central Texas Pediatric Orthopedics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

(512) 478-8116nmcmahon@ctpomd.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 11, 2023

Study Start

August 31, 2023

Primary Completion

October 1, 2024

Study Completion

January 1, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared outside of the study team.

Locations

US(1)