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

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