NCT05505981

An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis

Completed NA Last updated 22 December 2025

What this trial tests

NA trial testing Immediate PT in Lumbar Spondylosis in 64 participants. Completed in 1 July 2025.

Timeline

22 August 2022

Primary endpoint
1 July 2025

1 July 2025

Quick facts

Lead sponsor	Nationwide Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	22 August 2022
Primary completion	1 July 2025
Estimated completion	1 July 2025
Sites	2 locations across United States

Drugs / interventions tested

• Immediate PT
• Rest until pain resolves

Conditions studied

• Lumbar Spondylosis — all drugs for Lumbar Spondylosis →

Sponsor

Nationwide Children's Hospital

Who can join

Adults 10 to 19, any sex, with Lumbar Spondylosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rest Before Physical Therapy Is Not Necessary to Achieve Bony Healing of Lumbar Spondylolysis in Adolescent Athletes.
   Sweeney EA, Fischer A, Brna M, Martin L, et al · · 2026 · PMID 42099883 · DOI 10.1177/23259671261421595
2. Immediate physical therapy is beneficial for adolescent athletes with active lumbar spondylolysis: a multicentre randomised trial.
   Selhorst M, Sweeney E, Martin LC, Yang J, et al · · 2026 · PMID 41402030 · DOI 10.1136/bjsports-2025-110606