The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis

Location: Akron Children's Hospital, Sports Medicine. For research purposes, the study will
conclude at the end of the 6 weeks, however, if the patient has not met their physical
therapy goals, then physical therapy may continue upon collaboration with the patient and
his/her parents (if a minor), physical therapist, and referring physician.

Initially, there will be a letter to discuss the opportunity to participate in the research
study within initial intake paperwork. This will allow the patient and parent to have some
preliminary information prior to consulting with the therapist. As is customary, the patient
will be assigned to a licensed PT for the initial examination. The initial examining
therapist will be responsible to discuss and provide the patient with the pre-enrollment
information and informed consent (estimation of time needed approximately 15 minutes) and
may obtain consent any time after the pre-enrollment discussion or until the start of the
patient's second session. Upon agreement of participation in the study, the patient will be
able to complete the additional paperwork required as part of the study (outcome measures).
The patient will be randomized after self-inclusion in to the study into one of two groups
by role of dice where 1, 3, 5 is the intervention group and 2, 4, 6 is the clinical control
group.

The initial examination will include a subjective history taking, and objective assessment
with physical testing of the spine including active range of motion, passive range of
motion, strength assessment/endurance assessment of the lumbar musculature. The examination
will take approximately 45 minutes to 1 hour in length.

Description of Subjects (include age range, selection criteria, recruitment procedures,
anticipated and desired sample size)-

Subjects of the ages 12-21 are eligible to participate in this study. Due to the inclusion
of a vulnerable subject the responsible party/parent or guardian must grant inclusion and
must be able to attend the initial physical therapy evaluation of the minor and sign all
consenting documents. The physician offices within the surrounding hospital area and doctors
that typically refer to this clinic will be notified of the research study (attachment
physician letter and flyer for the facility). Patients will be included in the study if they
meet the following criteria:

1. Age of subject must be between 12-21 years old

2. Ability to read and understand the English language

3. Parent/caregiver consent

4. Written medical diagnosis of spondylolysis or spondylolithesis from the physician with
or without imaging.

The investigators plan to target a maximum of 120 subjects for the study, allowing a 20%
drop out rate. This study is powered at n=100 subjects for at least a minimal effect to be
calculated.

The investigators hypothesize a minimal effect on the patient group who receives the
investigational "motor control" or Pilates based exercise compared to the general core
strengthening program patient group.

Outcome Measures:

Numeric Pain Rating Scale

The numeric pain rating scale (NPRS) was used to capture the patient's level of pain.
Patients were asked to indicate the intensity of current, best, and worst levels of pain
over the past 24 hours using an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain
imaginable"). The average of the three ratings was used to represent the patient's level of
pain over the previous 24 hours. This procedure has been shown to have adequate reliability,
validity, and responsiveness in patients with LBP and has a minimally clinical important
difference of 2-point change in patients with mechanical low back pain.

Global Rating of Change Scale

At the follow-up evaluation, each patient will complete a global rating of change (GROC).
Patients will rate their overall perception of improvement since beginning treatment on a
scale ranging from -7 (a very great deal worse) to zero (about the same) to +7 (a very great
deal better). It has been recommended that scores on the GROC between ±3 and ±1 represent
small changes; scores between ±4 and ±5 represent moderate changes, and scores of ±6 or ±7
large changes.

The Modified Oswestry Disability Questionnaire (ODI)

The Modified ODI is a self-administered questionnaire that requires 5 minutes to complete
and 1 minute to score. Scores are associated with degree of disability ranging from minimal
to bedbound. The ODI is a condition-specific disability scale for patients with LBP,
consisting of 10 items addressing different aspects of function, each scored from 0-5 with
higher values representing greater disability. This modified ODI has been found to have high
levels of reliability, validity, and responsiveness. The MCID for the ODI has been
identified at six points .On this scale, 0-20 equates to minimal disability, 20-40 moderate
disability, 40-60 severe disability, 60-80 crippled, and 80-100 bed-bound or exaggerating.

Physical Endurance Tests/Measures

McGill has established a performance test to examine the endurance profiles of healthy young
men and women for the spine stabilizing musculature. Given the growing support for
quantification of endurance, these data of endurance times and their ratios between
extensor, flexor, and lateral flexor groups in healthy normal subjects are useful for
patient evaluation and for providing clinical training targets. To establish isometric
endurance holding times, as well as ratios between torso extensors, flexors, and lateral
flexors (stabilizers), for clinical assessment and rehabilitation targets. The tests proved
reliable, with reliability coefficients of >.97 for the repeated tests on 5 consecutive days
and again 8 weeks later.

Inclusion Criteria:

1. Age of subject must be between 12-21 years old

2. Ability to read and understand the English language

3. Parent/caregiver attendance and consent for initial evaluation

4. Written medical diagnosis of spondylolysis or spondylolithesis from the physician
with or without imaging

Exclusion Criteria:

1. Not meeting the inclusion criteria

2. Not able to attend therapy 2x's per week

3. If physician prescription requests only physical bracing as rendered treatment

4. If patient presents with signs of neurological compromise

5. Red flags during the medical screening that would require the patient to see the
physician