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Trial record 4 of 147 for:    "Spondylolysis"

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

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ClinicalTrials.gov Identifier: NCT03237104
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mitchell Selhorst, Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment
Low Back Pain Spondylosis Other: Immediate PT

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Back in the Game: A Pilot Study Assessing an Immediate Functional Progression Program in Athletes With a Spondylolysis.
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Time to return to sport (days) [ Time Frame: 1-6 months ]
    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


Secondary Outcome Measures :
  1. Change in Micheli Functional Scale (MFS) [ Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year ]
    Function

  2. Change in Numeric Pain Rating Scale [ Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year ]
    Pain

  3. Recurrence of low back symptoms [ Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year ]
    Patients will be asked if there low back pain (must have impaired ability to play sport or activities of daily living)

  4. adverse reaction [ Time Frame: 1-6 months ]
    An adverse reaction will be defined as 1) lumbar symptoms increasing enough to cause an unplanned visit to a physician or 2) the patient being placed on hold from therapy during the episode of care

  5. Change in MRI [ Time Frame: Baseline, 3 months ]
    Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis.



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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population of interest is young athletes with a recent spondylolysis injury.
Criteria

Inclusion Criteria:

  1. Age 10-19 years old
  2. 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.
  3. Participates in organized sport

Exclusion Criteria:

  1. Previous rest from activity >4 weeks without improved symptoms
  2. 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)
  3. Numbness and tingling in any lumbar dermatome
  4. Other injury or condition that would alter the plan of care for spondylolysis (i.e. pregnancy, anterior cruciate ligament (ACL) tear, concussion)
  5. History of lumbar surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237104


Contacts
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Contact: Mitchell Selhorst, DPT 614-355-9764 Mitchell.Selhorst@Nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Sports and Ortho PT Ortho Center Recruiting
Columbus, Ohio, United States, 43205
Contact: Candace Coffman, DPT    614-355-6060    Candace.Coffman@Nationwidechildrens.org   
Principal Investigator: Mitchell C Selhorst, DPT         
Nationwide Children's Hospital Sports and Ortho PT East Broad Recruiting
Columbus, Ohio, United States, 43213
Contact: Mitchell Selhorst, DPT    614-355-9764    Mitchell.Selhorst@Nationwidechildrens.org   
Principal Investigator: Mitchell C Selhorst, DPT         
Nationwide Children's Hospital Sports and Ortho PT Dublin Recruiting
Dublin, Ohio, United States, 43017
Contact: Shaun Coffman, DPT    614-355-8752    Shaun.Coffman@Nationwidechildrens.org   
Sub-Investigator: Shaun Coffman, DPT         
Nationwide Children's Hospital Sports and Ortho PT New Albany Recruiting
New Albany, Ohio, United States, 43054
Contact: William Rice, MPT    614-685-4348    William.Rice@Nationwidechildrens.org   
Sub-Investigator: William Rice, MPT         
Sub-Investigator: Erin Baumann, DPT         
Nationwide Children's Hospital Sports and Ortho PT Westerville Recruiting
Westerville, Ohio, United States, 43082
Contact: Mitchell Selhorst, DPT    614-355-9764    Mitchell.Selhorst@Nationwidechildrens.org   
Sub-Investigator: Joshua Kempton, DPT         
Sponsors and Collaborators
Nationwide Children's Hospital

Publications of Results:
Other Publications:
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Responsible Party: Mitchell Selhorst, Physical Therapist/Principle Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03237104     History of Changes
Other Study ID Numbers: IRB17-00258
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mitchell Selhorst, Nationwide Children's Hospital:
Adolescent
Athlete

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Spondylosis
Spondylolysis
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases