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

NCT01711203 | Completed

• 1 other identifier: Spondy 12-35
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylolisthesis; Spondylolysis; Children

Keywords

Spondylolysis; Spondylolisthesis; Rehabilitation; Physical Therapy; Children

Outcome Measures

Primary Outcomes (1)

• Global Rating of Change Scale

  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 .

  3 and 6 weeks and 3 months post discharge

Secondary Outcomes (1)

• Modified Oswestry Disability Index

  Initial evaluation, 3 and 6 weeks and 3 months post discharge

Other Outcomes (1)

• McGill's Physical Endurance Test Cluster

  Initial evaluation, 3 weeks and 6 weeks

Study Arms (2)

Motor Control

EXPERIMENTAL

Pilates-based exercise with verbal cues to facilitate motor control Plank progression, use of feedback tool VERBAL CUES FOR MOTOR CONTROL GROUP (could also include above cues) "Maintain neutral spine" "Not too arched, not too flexed" "Remember your pilates position" "Inhale, exhale" "Let me hear your breath"

Other: Motor Control

General strengthening

ACTIVE COMPARATOR

Patient group that will receive active strengthening without specific verbal cueing to recruit deeper abdominal musculature. Core strengthening and lower quarter strengthening is the focus of this group. Verbal cuing will include: VERBAL CUEING FOR NON-MOTOR CONTROL GROUP "Keep your back straight" "Don't slouch" "Don't arch your back" "Don't let your body move" "Nothing should move but your arms" "tighten up your abs" "suck in your stomach" "feet shoulder-width apart, knees bent, shoulders back, hold your stomach tight" Time will be kept the same as the intervention group.

Other: General Strengthening

Interventions

Motor Control OTHER

Exercises and verbal cues to facilitate deep abdominal control and contraction for muscular stabilization/re-training.

Motor Control

General Strengthening OTHER

General abdominal and lower quarter musculature strengthening

General strengthening

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age of subject must be between 8-21 years old
• Ability to read and understand the English language
• Parent/caregiver attendance and consent for initial evaluation
• Written medical diagnosis of spondylolysis or spondylolithesis from the physician with or without imaging

You may not qualify if:

• Not able to attend therapy 2x's per week
• If physician prescription requests only physical bracing as rendered treatment
• If patient presents with signs of neurological compromise
• Red flags during the medical screening that would require the patient to see the physician

Sponsors & Collaborators

• Megan Donaldson PT, PhD, FAAOMPT: lead
• Akron Children's Hospital: collaborator

Study Sites (1)

Akron Children's Hospital Orthopaedic and Sports Physical Therapy Center

Akron, Ohio, 44308, United States

Location

Related Publications (3)

• Dreisinger TE, Nelson B. Management of back pain in athletes. Sports Med. 1996 Apr;21(4):313-20. doi: 10.2165/00007256-199621040-00006.

  PMID: 8726348 BACKGROUND

• 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.

  PMID: 19352240 BACKGROUND

• 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.

  PMID: 16822889 BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis; Spondylolysis

Interventions

Functional Laterality

Condition Hierarchy (Ancestors)

Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Dominance, Cerebral; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Megan B Donaldson, PT PhD

  Walsh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

US (1)