Immediate Physical Therapy for Spondylolysis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on physical therapy and does not mention medication changes.
How is the Immediate Functional Progression Program (IFPP) treatment different from other treatments for spondylolysis?
The Immediate Functional Progression Program (IFPP) is unique because it focuses on a structured physical therapy approach that allows for immediate progression in activities, unlike traditional treatments that often rely on bracing and rest. This program aims to restore physical function and relieve pain without the need for restrictive bracing, which can be costly and difficult for patients to comply with.12345
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for adolescent athletes aged 10-19 with a recent diagnosis of spondylolysis, which is a type of stress fracture in the lower spine causing back pain. They must be active in sports at least twice weekly and have not taken more than four weeks off due to back pain. Those with previous lumbar surgery, numbness or tingling in the legs, or other serious conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Immediate Functional Progression Program (IFPP)
Participants in the IFPP group begin physical therapy immediately upon diagnosis, progressing through three phases based on function and pain criteria.
Control Group Treatment
Participants in the control group begin physical therapy after lumbar pain resolves, following a predetermined timeline for progression.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1 month, 3 months, 6 months, and 1 year.
Treatment Details
Interventions
- Immediate Functional Progression Program
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor
Children's Hospital Colorado
Collaborator