Anterior Knee Pain SyndromeNCT06031935
Yoga for Adolescent Knee Pain
A study testing Yoga in people with Anterior Knee Pain Syndrome, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with non-structural anterior knee pain
Who cannot join
- Any intra-articular injuries
- No access to internet
- Non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Central Texas Pediatric Orthopedics
Austin, Texas, 78723
Matthew D Ellington, MD, 512-478-8116, mellington@ctpomd.com
Niamh D McMahon, MS, 5124788116, nmcmahon@ctpomd.com
About this study
Official title: Yoga for Adolescent Anterior Knee Pain
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.
Read the 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.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Yoga
- Keywords
- Adolescent
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
The patients will receive links to two yoga videos. They will do each of these videos at home for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (4)
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.
Measured: Log will be recorded weekly for 8 weeks.
International Knee Documentation Committee (pedi-IKDC) Survey Score
Patient Reported Outcome survey. On a scale of 0-100. 100 means knee is fully functional.
Measured: baseline, 8 weeks and 4 months
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.
Measured: 8 weeks and 4 months
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.
Measured: baseline, 8 weeks and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Aug 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew D Ellington, MD, Principal investigator, University of Texas at Austin, Central Texas Pediatric Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031935
- Sponsor's protocol ID
- STUDY00004289
- Status last verified
- Sep 2023
- First submitted
- 23 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared outside of the study team.
Publications
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.
PubMed 18300936Donohue 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.
PubMed 16371493Hainsworth 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.
PubMed 29973555
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Adolescent Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT06031935
- Acronym / sponsor ID
- STUDY00004289
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga study group | Experimental | Behavioral: YogaThis 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with non-structural anterior knee pain
Key exclusion criteria (3 listed)
- Any intra-articular injuries
- No access to internet
- Non-english speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaThe patients will receive links to two yoga videos. They will do each of these videos at home for 4 weeks. | Behavioural | Yoga study group |
Primary outcome
Patient Flexibility
Time frame: Baseline and 8 weeks
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.
4 secondary outcomes
Number of views of yoga videos
Time frame: Log will be recorded weekly for 8 weeks.
International Knee Documentation Committee (pedi-IKDC) Survey Score
Time frame: baseline, 8 weeks and 4 months
Yoga video satisfaction survey
Time frame: 8 weeks and 4 months
Patient-Reported Outcomes Measurement Information Systems (PROMIS) pain interference scale
Time frame: baseline, 8 weeks and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 18300936Galantino 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.
- Background: PubMed 16371493Donohue 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.
- Background: PubMed 29973555Hainsworth 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.
- Individual participant dataSharing planned: No. No individual participant data will be shared outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Ellington, MD principal investigator
University of Texas at Austin, Central Texas Pediatric Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Anterior Knee Pain Syndrome, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator ((512) 478-8116, nmcmahon@ctpomd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Flexibility (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031935, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.