This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS). Note: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects while we seek additional funding to follow all subjects through 8 years.
Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged 40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function and/or appearance. Specific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status, education) and comorbidities \[mental health, body mass index (BMI) and bone mineral density (BMD)\] on adverse events and treatment outcomes for both the nonoperative and operative arms. Incorporate these variables into a prediction model to help identify those patients most likely to benefit from either a surgical or nonoperative approach
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.
Northwestern University
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Maryland Spine Center
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore
Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis). SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Time frame: Baseline, 2-year
Scoliosis Research Society Quality of Life (SRS QOL) Subscore
Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort. SRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.
Time frame: Baseline, 2-year
Oswestry Disability Index (ODI) - Randomized Cohort
Change was calculated as the ODI score at 2-year minus the value at Baseline in Randomized Cohort (intent-to-treat analysis). ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.
Time frame: Baseline, 2-year
Oswestry Disability Index (ODI)
Change was calculated as the ODI score at 2-year as treated follow-up minus the value at baseline. ODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.
Time frame: Baseline, 2-year
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New York University
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
University of Virginia
Charlottesville, Virginia, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Hopital du Sacre'
Montreal, Quebec, Canada