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

NCT03237104 | Completed

• 1 other identifier: IRB17-00258
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Low Back Pain; Spondylosis

Keywords

Adolescent; Athlete

Outcome Measures

Primary Outcomes (1)

• Time to return to sport (days)

  The number of days from diagnosis of spondylolysis to the point the patient passes all criteria of the PT program and is cleared to return to sport by the physician

  1-6 months

Secondary Outcomes (5)

• Change in Micheli Functional Scale (MFS)

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

• Change in Numeric Pain Rating Scale

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

• Recurrence of low back symptoms

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

• adverse reaction

  1-6 months

• Change in MRI

  Baseline, 3 months

Study Arms (1)

acute spondylolysis

Athletes who meet the inclusion criteria and consent to participate in the pilot study will be referred directly to PT care for 2 times per week until cleared to return to sport.

Other: Immediate PT

Interventions

Immediate PT OTHER

Athletes will perform phase I (neutral spine) of the program and progress to phase II (functional motion) as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks.

acute spondylolysis

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population of interest is young athletes with a recent spondylolysis injury.

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (5)

Nationwide Children's Hospital Sports and Ortho PT Ortho Center

Columbus, Ohio, 43205, United States

Location

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, 43213, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Dublin

Dublin, Ohio, 43017, United States

Location

Nationwide Children's Hospital Sports and Ortho PT New Albany

New Albany, Ohio, 43054, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Westerville

Westerville, Ohio, 43082, United States

Location

Related Publications (4)

• Anderson K, Sarwark JF, Conway JJ, Logue ES, Schafer MF. Quantitative assessment with SPECT imaging of stress injuries of the pars interarticularis and response to bracing. J Pediatr Orthop. 2000 Jan-Feb;20(1):28-33.

  PMID: 10641684 BACKGROUND

• Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.

  PMID: 19352240 BACKGROUND

• Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, Welder E, MacDonald J. Timing of Physical Therapy Referral in Adolescent Athletes With Acute Spondylolysis: A Retrospective Chart Review. Clin J Sport Med. 2017 May;27(3):296-301. doi: 10.1097/JSM.0000000000000334.

  PMID: 27347866 RESULT

• Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, MacDonald J. Long-Term Clinical Outcomes and Factors That Predict Poor Prognosis in Athletes After a Diagnosis of Acute Spondylolysis: A Retrospective Review With Telephone Follow-up. J Orthop Sports Phys Ther. 2016 Dec;46(12):1029-1036. doi: 10.2519/jospt.2016.7028. Epub 2016 Nov 8.

  PMID: 27825292 RESULT

MeSH Terms

Conditions

Low Back Pain; Spondylosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist/Principle Investigator

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: July 31, 2017
• Primary Completion: October 31, 2020
• Study Completion: January 8, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

US (5)