Back in the Game: An Immediate Functional Progression Program in Athletes With a Spondylolysis.
Public ClinicalTrials.gov record NCT03237104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Back in the Game: A Pilot Study Assessing an Immediate Functional Progression Program in Athletes With a Spondylolysis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Half of all adolescents report experiencing low back pain (LBP), and adolescents who are active in sport report an even higher rate. The most common identifiable cause of LBP in the adolescent athlete is a stress fracture in the low back, known as a spondylolysis. Spondylolysis injuries have been found in up 47% of young athletes with LBP. The current recommendations of care for a spondylolysis consist of rest for at least 3 months, bracing, and physical therapy. These recommendations result in athletes being out of sport for as long as 46 months, and are based on low level evidence and expert opinion. In addition to the long period out of sport, 42% have poor long-term outcomes, and 1 in 6 athletes are no longer able to play at their former level specifically due to their back injury. These long periods out of sport and poor long-term clinical outcomes suggest current care recommendations are suboptimal. The overall objective of the proposed research is to test the feasibility of using an early functional progression program to reduce athletes' time out of sport and improve clinical outcomes. Specifically, to pilot altering the rest period in athletes with a spondylolysis and begin rehabilitation immediately. These young athletes will return to sport as they are able, after demonstrating predetermined pain free functional ability. Twelve young athletes with a confirmed active spondylolysis will be recruited to undergo the early function progression intervention. The specific aims of this study are to assess the feasibility of implementing the immediate functional progression protocol, refine the protocol if necessary, and estimate potential effectiveness of this intervention. The athletes' outcomes will be compared to historical controls. The investigators hypothesize that the immediate functional progression program can be successfully implemented and with only minor changes will be suitable for use in larger trials. It is estimated the immediate functional progression program has the potential to return athletes to sport more than a month sooner than current practice. Once able to demonstrate the feasibility of the early functional progression program, the investigators plan to progress this work into larger trials to fully assess effectiveness, safety and long-term outcomes.
Study identification
- NCT ID
- NCT03237104
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 19 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2017
- Primary completion
- Oct 30, 2020
- Completion
- Jan 7, 2021
- Last update posted
- Jan 10, 2021
2017 – 2021
United States locations
- U.S. sites
- 5
- U.S. states
- 1
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nationwide Children's Hospital Sports and Ortho PT Ortho Center | Columbus | Ohio | 43205 | — |
| Nationwide Children's Hospital Sports and Ortho PT East Broad | Columbus | Ohio | 43213 | — |
| Nationwide Children's Hospital Sports and Ortho PT Dublin | Dublin | Ohio | 43017 | — |
| Nationwide Children's Hospital Sports and Ortho PT New Albany | New Albany | Ohio | 43054 | — |
| Nationwide Children's Hospital Sports and Ortho PT Westerville | Westerville | Ohio | 43082 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03237104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 10, 2021 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03237104 live on ClinicalTrials.gov.