The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis
Condition: Spondylolisthesis; Spondylolysis; Children
MeSH terms: Spondylolisthesis; Spondylolysis
Study type: Interventional

Summary: 
      Purpose: To determine the effectiveness of an augmented Pilates program, when combined to a
      multimodal strengthening program, for patients under the age of 21, who have spondylolysis
      and/or spondylolisthesis.

      Significance of the topic: Spondylolysis and spondylolisthesis are often diagnosed in
      children and adolescents presenting with low back pain.

      A randomized, clinical trial, test-retest design, with a 3 week and 6 week assessment with
      functional performance test measures, exercise logs, adherence scale for patient and parent
      perception, and outcome measures (Global rating of change (GROC) and Modified Oswestry
      Disability Index (ODI)). This study will attempt to obtain at least 120 subjects that will be
      randomized into two groups: bracing and a general strengthening program vs. bracing and a
      Pilates/motor learning program combined with a general strengthening program.

      This study will begin with an initial examination and continue with treatment sessions
      2x/week for 6 weeks. A follow up phone call will be conducted at 3 months after completing
      the 6-week protocol. The follow up phone call will be an oral conducted GROC and ODI outcome
      measures.
    

Detailed description: 
      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 8-21 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 8-21 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 large 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.
    

Intervention name(s): Motor Control; General Strengthening
Intervention type(s): Other; Other
Intervention description(s): Exercises and verbal cues to facilitate deep abdominal control and contraction for muscular stabilization/re-training.; General abdominal and lower quarter musculature strengthening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spondylolysis; Spondylolisthesis; Rehabilitation; Physical Therapy; Children