A total of 60 adolescent athletes ages 10-19 with an active spondylolysis will be
recruited and enrolled via two study sites. Enrolled athletes will be randomly assigned
into either 1) novel IFPP, which will begin rehabilitation immediately upon diagnosis, or
2) control (standard care), which will not begin rehabilitation until lumbar pain
resolution.
Aim 1: Compare the safety and tolerability of the IFPP with a standard care approach
(control) after diagnosis of active spondylolysis. Working hypothesis: Participation in
the IFPP will not increase adverse events or delay recovery in adolescents compared to
those in the control group who do not exercise during the immediate period following
diagnosis of spondylolysis.
Aim 2: Assess the effects of the IFPP compared to a standard care approach (control) on
improved outcomes among adolescent athletes with an active spondylolysis. Working
hypothesis: Athletes randomly assigned in the IFPP will have greater and quicker
improvements in outcomes (Function, Pain, Quality of Life, and Edema on MRI) than
athletes in the control group.
All participants will rest from sport until they meet the return-to-sport criteria. After
randomizing, both IFPP and control groups will receive physical therapy (PT) care two
times/week until they meet the return-to-sport criteria. Each PT session will last
approximately one hour, and both groups will use the same return-to-sport criteria.
However, the difference between the IFPP and control group is the time when PT begins.
The IFPP group will begin PT immediately upon diagnosis, while the control group will
wait until lumbar pain resolves. Interventions in both groups will be standardized across
both sites.
Return-to-Sport Criteria: The athlete must meet all below criteria to be cleared to
return to sport. Athletes will not be told the return-to-sport criteria as this may
encourage athletes to under report pain to be cleared sooner.
Pain-free repetitive motion to end-range in all cardinal lumbar directions.
Completion of two weeks of return-to-sport activity in physical therapy without
pain.
0% score on Micheli Functional Scale.
Immediate Functional Progression Program Group: Participants in the IFPP group will begin
PT immediately (<1 week). The IFPP is a systematic rehabilitation program divided into
three phases to allow adolescent athletes with an active spondylolysis to begin exercise
immediately without exacerbating symptoms. Progression through the phases is based upon
meeting standard function and pain criteria.
Control Group: Participants in the control group will wait to start PT until their lumbar
pain has resolved. This approach is a common method currently used to treat active
spondylolysis. Physicians will assess the resolution of lumbar pain every four weeks at
their follow-up visits (four, eight, and 12 weeks). Participants will begin PT (<1week)
after the first physician visit where they report no LBP with rest and ADL's.
Participants in the control group will follow the same PT treatment program, but
progression will be based upon a predetermined timeline as their pain has already
resolved (phase I two weeks; phase II two weeks; phase III until passes return-to-sport
criteria).
Setting: The proposed RCT will be conducted at the Sports Medicine/Physical Therapy
Clinics at Nationwide Children's Hospital (NCH) in Columbus, Ohio, and Children's
Hospital Colorado (CHCO) in Denver, Colorado.
Randomization and Blinding: The REDCap system will block randomize participants into
either the IFPP or control group. Block randomization will ensure predetermined ratios of
participants in each group (IFPP:Control = 1:1) at each recruitment location (NCH:CHCO =
2:1). This study will be unblinded as it will be impractical to blind treating clinicians
or patients to the randomized treatment approach.
Aim 1: Compare the safety and tolerability of the IFPP with a standard care approach
(control) after diagnosis of active spondylolysis. Working hypothesis: Participation in
the IFPP will not increase adverse events or delay recovery in adolescents compared to
those in the control group who do not exercise during the immediate period following
diagnosis of spondylolysis.
1.a.) Adverse events: For this study, an adverse reaction (mild) will be defined as
lumbar symptoms increasing enough to cause 1) an unplanned visit to a physician or 2) a
pause in therapy during the episode of care. Previous research has demonstrated that
approximately 8% of athletes have a mild adverse event during standard care. No moderate
or severe adverse events have been reported to date.
1.a.i.) Monitoring Adverse events: We will track all physician visits within the health
system (NCH or CHCO) regarding the LBP episode of care. Any unplanned physician visits
due to increased symptoms or formal pausing of rehabilitation by the physician will be
documented as an adverse event. Additionally, throughout care and during the follow-up
questionnaires, participants will be asked if they have had any medical appointments for
the LBP outside of their research study session. If the participant answers, "Yes," study
staff will follow up to determine if this meets the criteria for an adverse event. The
CRN will act as an independent safety monitoring board to assess all potential adverse
events.
b.) Data Analysis: For Aim 1, descriptive statistics will assess the frequency of
each treatment group's adverse events.
Aim 2: Assess the effects of the IFPP compared to a standard care approach (control)
on improved outcomes among adolescent athletes with an active spondylolysis. Working
hypothesis: Athletes randomly assigned in the IFPP will have greater and quicker
improvements in outcomes (Function, Pain, Quality of Life, and Edema on MRI) than
athletes in the control group.
c.) Data Analysis: An intent-to-treat design with the multiple imputation model will
be used for any missing values. Linear mixed-effects models will investigate the
effect of rehabilitation timing on pain, function, quality of life, and change in
edema. The linear mixed-effects models will provide information about how the
patient's sex, type of lesion (stress reaction, unilateral, or bilateral lysis), and
treatment location modify treatment effectiveness. Participant baseline
characteristics are accounted for by the random intercepts component of the model,
while the model's random slope component will account for patients with varying
response levels over time. Linear mixed-effects models can give estimates of mean
differences in the outcomes between groups at each time point along with an estimate
of within and between group correlation that are necessary for sample size
calculations for future studies. Time to event analyses will also be conducted.
These include Kaplan-Meier curves of the survival probability of being cleared to
return to sport for the two groups, while a Log-Rank test will compare the
differences in the median time to return to sports between the groups. Additionally,
we will use a Cox Proportional Hazards Model to determine the extent to which the
IFPP modifies time to return to sport, adjusting for potential covariates, including
sex and type of lesion (stress reaction, unilateral, or bilateral lysis). This pilot
trial will obtain preliminary effect sizes that will help better estimate the
anticipated effect for the full multi-center RCT, as well as to better estimate the
required number of patients for future studies.