Clinical trial NCT01711203: The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis
Official title: The Addition of a Pilates Program for Short-Term Improvements in Self Report and Physical Functions With Patients With Spondylolysis or Spondylolisthesis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylolisthesis
Spondylolysis
Children
Keywords: Spondylolysis
Spondylolisthesis
Rehabilitation
Physical Therapy
Children
Lead sponsor: Walsh University
Sponsor class: OTHER
Collaborators: name: Akron Children's Hospital
First posted: 2012-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age of subject must be between 8-21 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

Primary outcomes:
measure: Global Rating of Change Scale
timeFrame: 3 and 6 weeks and 3 months post discharge
Secondary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: Initial evaluation, 3 and 6 weeks and 3 months post discharge
Other outcomes:
measure: McGill's Physical Endurance Test Cluster
timeFrame: Initial evaluation, 3 weeks and 6 weeks
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center
state: Ohio
Study officials:
affiliation: Walsh University
name: Megan B Donaldson, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dreisinger TE, Nelson B. Management of back pain in athletes. Sports Med. 1996 Apr;21(4):313-20. doi: 10.2165/00007256-199621040-00006.
citation: Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.
citation: Cavalier R, Herman MJ, Cheung EV, Pizzutillo PD. Spondylolysis and spondylolisthesis in children and adolescents: I. Diagnosis, natural history, and nonsurgical management. J Am Acad Orthop Surg. 2006 Jul;14(7):417-24. doi: 10.5435/00124635-200607000-00004.