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NCT03237104 · ClinicalTrials.gov registry record
Back in the Game: An Immediate Functional Progression Program in Athletes With a Spondylolysis.
A clinical trial, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- 12
- Enrollment target
NCT03237104: Completed study, sponsored by Nationwide Children's Hospital.
NCT03237104 is a clinical trial that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03237104 has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
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 progr
Primary Outcome
The number of days from diagnosis of spondylolysis to the point the patient passes all criteria of the PT program and is cleared to return to sport by the physician
Interventions
- OTHER Immediate PT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2021-01-08 |
What the finished NCT03237104 record still lists
NCT03237104 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Immediate PT is the first listed.
NCT03237104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03237104 about?
NCT03237104 is a clinical study titled "Back in the Game: An Immediate Functional Progression Program in Athletes With a Spondylolysis.". 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 fo...
What is the current status of trial NCT03237104?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2017-07-31. Estimated completion is 2021-01-08.
What interventions are being tested in trial NCT03237104?
The interventions under investigation include: Immediate PT (OTHER).
Who is sponsoring clinical trial NCT03237104?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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