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NCT05505981 · ClinicalTrials.gov registry record · NA
An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis
A NA study of Lumbar Spondylosis, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 2
- Study locations
NCT05505981: Completed NA study of Lumbar Spondylosis, sponsored by Nationwide Children's Hospital.
NCT05505981 is a NA study of Lumbar Spondylosis that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 64 participants, below the 119-participant average among 4 other Lumbar Spondylosis trials with a reported enrollment target (46% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05505981, a NA study of Lumbar Spondylosis, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 2
- Study locations
Study Summary
Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion from sports or an active lifestyle. Standard care of spondylolysis in adolescent athletes is primarily based on expert opinion, with dramatic variations in clinical practice, including restrictive bracing, extended rest periods before the intervention, long durations out of sport and activity, and suboptimal long-term clinical outcomes. As the next step towards our research goal, the overall objective of this pilot study is to perform a pilot randomized controlled trial to assess a novel rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. Participants randomized to the IFPP group will begin physical therapy immediately (\<1 week) after diagnosis. In contrast, those in the standard care group (control) will not start physical therapy until their pain has resolved. Aim 1 will evaluate the effects of the IFPP on outcomes (Function, Pain, Quality of Life, and Edema on MRI) among adolescent athletes with an active spondylolysis. Aim 2 will assess the feasibility of performing a full randomized trial using the novel IFPP to treat athletes ages 10-19 with an active spondylolysis. Aim 3 will compare the tolerability of the IFPP to standard care. This pilot study will lay the necessary groundwork to perform a larger hypothesis-driven randomized controlled trial.
Primary Outcome
The Micheli Functional Scale is a measure of function and pain designed for adolescent athletes with low back pain. The MFS is score on 0-100% scale with 0% representing no disability and 100% representing maximum disability.
Conditions Studied
Interventions
- OTHER Immediate PT
- OTHER Rest until pain resolves
Study Locations (2)
Colorado
- Children's Hospital of Colorado - Denver
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-08-22 |
| Est. Completion | 2025-07-01 |
| Phase | NA |
What the finished NCT05505981 record still lists
NCT05505981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 119-participant average among 4 other Lumbar Spondylosis trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Lumbar Spondylosis appearing as the primary indexed condition, and to 2 interventions - of which Immediate PT is the first listed.
NCT05505981 reports a single indexed study location in Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT05505981 about?
NCT05505981 is a clinical study titled "An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis". Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion...
What is the current status of trial NCT05505981?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2022-08-22. Estimated completion is 2025-07-01.
What conditions does trial NCT05505981 study?
This clinical trial studies the following conditions: Lumbar Spondylosis.
What interventions are being tested in trial NCT05505981?
The interventions under investigation include: Immediate PT (OTHER), Rest until pain resolves (OTHER).
Who is sponsoring clinical trial NCT05505981?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05505981 being conducted?
This trial has 2 study locations across Colorado, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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