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



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:10 - 19
Updated:2/1/2019
Start Date:July 31, 2017
End Date:October 31, 2019
Contact:Mitchell Selhorst, DPT
Email:Mitchell.Selhorst@Nationwidechildrens.org
Phone:614-355-9764

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Back in the Game: A Pilot Study Assessing an Immediate Functional Progression Program in Athletes With a Spondylolysis.

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.

Athletes who meet the inclusion criteria and consent to participate in the pilot study will
be referred directly to physical therapy (PT) care for 2 times per week. Athletes will
follow-up with their co-investigating physician every 4 weeks until discharge. The immediate
functional progression program will be performed by physical therapists trained in the
treatment protocol. Athletes will perform phase I of the program and progress to phase II 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.

Phase I Immediate Functional Progression Program Core strengthening in neutral spine Treat
directional preference if identified Hip strengthening Peri-scapular strengthening
Flexibility exercises Manual Therapy as needed Modalities for pain (use sparingly)

Phase II Immediate Functional Progression Program Core strengthening in functional range Hip
and peri-scapular strengthening Flexibility exercises Manual Therapy (use sparingly) Phase
III Immediate Functional Progression Program- Return to Sport Return to sport activity with
focus on functional return to all aspect of sport.

Signs of not responding as anticipated during the immediate functional progression program:
Inability to meet long-term goals of care in PT including inability to return to sport due to
low back pain within three months, an increase in pain or no significant decrease in pain
(<2/10) at physician visits until patient reports <2/10 pain with activity.

Sample Size A sample size of 12 will be recruited for this pilot trial. As there is a
nonlinear relationship between confidence interval (CI) width and sample size, further
increases in participants beyond 12 have a diminishing benefit on precision for preliminary
studies.

Data Analysis Descriptive statistics of the patient demographics and outcome variables will
be reported. Inferential calculations will not be performed as this is a pilot to demonstrate
the feasibility of implementing the proposed immediate functional progression program.

Aim 1: Discussion of the success of implementing the immediate functional progression program
will occur during and after care of each patient. The PI will monitor patient documentation
to assess adherence to the research protocol in care. Adverse events will be monitored, the
immediate functional progression program will be considered acceptably tolerated by patients
if <3 adverse events are observed.

Aim 2: (Potential Problems and Alternative strategies) Minor problems identified in the pilot
study will serve to refine to the protocol for the full randomized clinical trial. Larger
potential problems include non-adherence to the experimental treatment protocol. The risk of
this potential problem will be reduced by training of all staff involved in the research
process. If a problem is found in the experiment protocol that inhibits patients from
satisfactorily progressing in their care, the co-investigators will meet and decide on a
course of action to fix this issue. An alteration in the experimental protocol that results
in improved care would be considered a positive outcome, as the goal of this pilot study is
to demonstrate viability and feasibility for a larger clinical trial.

Aim 3: Clinical outcomes including pain, function, time to return to sport and recurrence of
symptoms will be compared against historical controls to assess for potential efficacy.
Historical controls for quality of life are not available in this population. Time to return
to sport will be the primary outcome of interest. A decrease in return to sport time of > 30
days compared to the historical control time of 3.8 months without a notable worsening of
other outcomes will indicate future research is warranted.

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
We found this trial at
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sites
Columbus, Ohio 43205
Principal Investigator: Mitchell C Selhorst, DPT
Phone: 614-355-6060
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Columbus, Ohio 43213
Principal Investigator: Mitchell C Selhorst, DPT
Phone: 614-355-9764
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Dublin, Ohio 43017
Phone: 614-355-8752
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New Albany, Ohio 43054
Phone: 614-685-4348
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Westerville, Ohio 43082
Phone: 614-355-9764
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