Dr. Keith Bridwell is the Primary Investigator for a multicenter study previously funded by the National Institutes of Health (NIH) to evaluate the effectiveness of nonoperative and operative treatments in adults with lumbar scoliosis and to identify important clinical and radiographic factors that may influence outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS). NOTE: We are no longer enrolling new patients in this study. Enrollment was complete in 2014. This study is now in follow-up. For additional information, please contact Christine Baldus, RN, MHS via email or call (314) 747-2655.
The purpose of this study: The goal of this study is to determine which treatments are most likely to help patients with symptomatic lumbar scoliosis. The current treatment options available are nonoperative treatment (specifically, intensified physical therapy, medications, spinal injections and/or observation) and operative treatment (spinal fusion and deformity correction surgery). By tracking treatments received and the patient’s self-reported pain, activity and satisfaction, we hope to learn which treatment options are the best for which patients under what circumstances.
Inclusion Criteria: All patients were 40 – 80 years of age at the time of enrollment with a double major or thoracolumbar/lumbar scoliosis. The lumbar Cobb angle had to measure a minimum of 30 degrees. Patients could not have had prior spine fusion surgery of their thoracic or lumbar spine.
Study Description: Patients could participate in two different ways:
- Randomized study: Random study assignment means information about the patient was entered into the computer (age, gender, scoliosis curve size, etc.). The computer then assigned the patient to operative or nonoperative treatment.
- Observational study: Patients declining random study assignment were offered to participate in the Observational study where they, along with their doctor, chose the treatment plan (operative or nonoperative) that was most appropriate for them.
If the patient was assigned or chose operative treatment, surgery was usually scheduled within the next 6 months. If the patient was assigned/chose nonoperative treatment, treatments began as soon as possible. Nonoperative treatments usually include a combination of treatments (medications, physical therapy, injections, bracing, etc.) designed specifically for the participant. Participants receiving nonoperative treatments could “crossover” to operative treatment if they and their doctor see no improvement.
In this study, ALL patients receive care. There is no “placebo” in this study. There are no experimental therapies, medications or operations being used. All treatments for all participants are considered standard of care. All patients are monitored closely by completing questionnaires about their health status, spine treatments, pain, activities and satisfaction every six months and returning to the study center for periodic clinical visits. All patients will be followed for 8 years. Patients are reimbursed for their time. Their contributions, through participation, will help us understand the best treatment options for adults with lumbar scoliosis.