CompletedNot Applicable

An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis

United States64 participantsStarted 2022-08-22

Plain-language 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.

Who can participate

Age range10 Years – 19 Years

SexALL

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Inclusion criteria

✓. Age between 10 and 19 years.
✓. 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.
✓. Organized sport participation at least two times per week at the time of diagnosis or onset of LBP.

Exclusion criteria

✕. Previous rest from activity \> four weeks due to LBP
✕. Numbness or tingling in any lumbar dermatome.
✕. 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).
✕. History of lumbar spine surgery.

What they're measuring

Change in Micheli Functional Scale (MFS)

Timeframe: Baseline, 1 month, 3 months, 6 months, 1 year

Change in edema on MRI

Timeframe: Baseline, 3 months

Change in Quality of Life

Timeframe: Baseline, 1 month, 3 months, 6 months, 1 year

Time to return to sport (days)

Timeframe: 1-6 months

Trial details

NCT IDNCT05505981

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

View on ClinicalTrials.gov More Lumbar Spondylosis trials