RECRUITING

An Immediate Functional Progression Program for Adolescent Athletes With Spondylolysis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-22
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05505981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mitchell Selhorst, DPT, PhD
CONTACT
614-355-9764
Mitchell.Selhorst@Nationwidechildrens.org
Anastasia Fischer, MD
CONTACT
Anastasia.Fischer@Nationwidechildrens.org

Study Locations (Sites)

Children's Hospital of Colorado
Denver, Colorado, 80045
United States
Nationwide Children's Hospital
Columbus, Ohio, 43215
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-22
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2022-08-22
Study Completion Date2025-09-01

Terms related to this study

Keywords Provided by Researchers

  • Adolescent
  • Athlete
  • low back pain

Additional Relevant MeSH Terms

  • Lumbar Spondylosis