Back in the Game: An Immediate Functional Progression Program in Athletes With a Spondylolysis.

Completed

Conditions studied: Low Back Pain, Spondylosis

In brief

Half of all adolescents report experiencing low back pain (LBP), and adolescents who are active in sport report an even higher rate. The most common identifiable cause of LBP in the adolescent athlete is a stress fracture in the low back, known as a spondylolysis. Spondylolysis injuries have been found in up 47% of young athletes with LBP. The current recommendations of care for a spondylolysis consist of rest for at least 3 months, bracing, and physical therapy. These recommendations result in athletes being out of sport for as long as 46 months, and are based on low level evidence and expert opinion. In addition to the long period out of sport, 42% have poor long-term outcomes, and 1 in 6 athletes are no longer able to play at their former level specifically due to their back injury. These long periods out of sport and poor long-term clinical outcomes suggest current care recommendations are suboptimal. The overall objective of the proposed research is to test the feasibility of using an early functional progression program to reduce athletes' time out of sport and improve clinical outcomes. Specifically, to pilot altering the rest period in athletes with a spondylolysis and begin rehabilitation immediately. These young athletes will return to sport as they are able, after demonstrating predetermined pain free functional ability. Twelve young athletes with a confirmed active spondylolysis will be recruited to undergo the early function progression intervention. The specific aims of this study are to assess the feasibility of implementing the immediate functional progression protocol, refine the protocol if necessary, and estimate potential effectiveness of this intervention. The athletes' outcomes will be compared to historical controls. The investigators hypothesize that the immediate functional progression program can be successfully implemented and with only minor changes will be suitable for use in larger trials. It is estimated the immediate functional progression program has the potential to return athletes to sport more than a month sooner than current practice. Once able to demonstrate the feasibility of the early functional progression program, the investigators plan to progress this work into larger trials to fully assess effectiveness, safety and long-term outcomes.

Key facts

Study ID

NCT03237104

Run by

Nationwide Children's Hospital

People needed

12

Starts

2017-07-31

Expected to finish

2021-01-08

Last updated by the study team

2021-01-11

Who can join

Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 10-19 years old
• Diagnosed with a spondylolysis through magnetic resonance imaging (MRI) with active signs of healing. Signs of active healing are defined as edema noted on MRI.
• Participates in organized sport

You may not qualify if…

• Previous rest from activity >4 weeks without improved symptoms
• Red flags present (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing)
• Numbness and tingling in any lumbar dermatome
• Other injury or condition that would alter the plan of care for spondylolysis (i.e. pregnancy, anterior cruciate ligament (ACL) tear, concussion)
• History of lumbar surgery

Where it is running

• Nationwide Children's Hospital Sports and Ortho PT Ortho Center — Columbus, Ohio, United States
• Nationwide Children's Hospital Sports and Ortho PT East Broad — Columbus, Ohio, United States
• Nationwide Children's Hospital Sports and Ortho PT Dublin — Dublin, Ohio, United States
• Nationwide Children's Hospital Sports and Ortho PT New Albany — New Albany, Ohio, United States
• Nationwide Children's Hospital Sports and Ortho PT Westerville — Westerville, Ohio, United States

Full record on ClinicalTrials.gov

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