Immediate rehabilitation program for young athletes with spondylolysis

Back in the Game: An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis: A Multi-Center Randomized Pilot Trial

This study is testing a new rehab program that starts physical therapy right away for young athletes with spondylolysis to see if it helps them recover faster and feel better compared to waiting until their pain goes away.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 10 Years to 19 Years
• Sex: All
• Sponsor: Nationwide Children's Hospital (other)
• Locations: 2 sites (Denver, Colorado and 1 other locations)
• Trial ID: NCT05505981 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate a novel rehabilitation strategy called the immediate functional progression program (IFPP) for adolescent athletes diagnosed with active spondylolysis, a common cause of low back pain. A total of 60 participants aged 10-19 will be randomly assigned to either the IFPP group, which begins physical therapy immediately upon diagnosis, or a control group that will not start rehabilitation until pain resolves. The study will compare the safety, tolerability, and effectiveness of the IFPP against standard care, assessing outcomes such as function, pain, quality of life, and MRI findings. Both groups will receive physical therapy twice a week until they meet return-to-sport criteria.

Who should consider this trial

Good fit: Ideal candidates are adolescent athletes aged 10-19 with an active spondylolysis diagnosis confirmed by MRI.

Not a fit: Patients with previous long-term rest from activity due to low back pain or other significant injuries may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could lead to faster recovery and return to sports for adolescent athletes suffering from spondylolysis.

How similar studies have performed: While the approach of immediate rehabilitation is innovative, similar studies have shown varying success, indicating a need for further investigation.

Eligibility criteria

Inclusion criteria

1. Age between 10 and 19 years.
2. Active spondylolysis diagnosed by a participating physician using MRI. Signs of active spondylolysis are defined as edema in the posterior elements of the lumbar vertebrae at the pars interarticularis with or without a fracture.
3. Organized sport participation at least two times per week at the time of diagnosis or onset of LBP.

Exclusion criteria

1. Previous rest from activity \> four weeks due to LBP
2. Numbness or tingling in any lumbar dermatome.
3. Other injury or condition that would alter the plan of care for spondylolysis (i.e., pregnancy, anterior cruci-ate ligament tear in the knee, concussion).
4. History of lumbar spine surgery.

Where this trial is running

Denver, Colorado and 1 other locations

• Children's Hospital of Colorado — Denver, Colorado, United States (RECRUITING)
• Nationwide Children's Hospital — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Mitchell Selhorst, DPT, PhD

Conditions: Lumbar Spondylosis, Adolescent, Athlete, low back pain