A Multicenter NIH-Sponsored Prospective Study of Quality of Life in Adult Scoliosis (ASLS):
Dr. Keith Bridwell is the Primary Investigator for a multicenter study 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).
The purpose of this study: The goal is to determine which treatments are most likely to help patients with symptomatic lumbar scoliosis. To accomplish this, we will follow you closely to see which treatment makes you better. Which treatment provides you the most pain relief? Which treatment allows you to return to your daily and recreational activities? We will monitor the individualized treatments designed for you according to your symptoms.
The current treatment options available are nonoperative treatment (specifically, intensified physical therapy, medications, spinal injections and observation) and operative treatment (spinal fusion and deformity correction surgery). By tracking treatments received and patient’s self-reported pain, activity and satisfaction, we hope to learn which treatment options are the best for which patients under what circumstances.
· Adults ages 40-80 years of age
· Double major or thoracolumbar/lumbar scoliosis with minimum Cobb angle of 30 degrees
· No prior spine fusion surgery in the thoracic or lumbar spine
Study Description: There are two different ways you choose to participate in this study.
The best “science” method is for the patient to agree to be “randomized” to operative or nonoperative care. This means you agree to be assigned randomly to either receive operative treatment or nonoperative treatment. Random assignment means information about you is entered into the computer and the computer determines which treatment you will receive. IF you are assigned operative treatment, surgery is usually scheduled in the next 6 months. IF you are assigned nonoperative treatment, you would start treatments 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 can “crossover” to operative treatment if they and their doctor see no improvement.
Although both, operative and nonoperative treatments are known to help patients, you may have a STRONG preference for operative or nonoperative care. In that case, you may be able to participate in the Observational study. Treatments, follow-up, and all study requirements are the same, regardless if you are in the Randomized or Observational study.
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 will be monitored closely. We will want to know how you think you are doing, so all participants will complete questionnaires about their health status, spine treatments, pain, activities and satisfaction every three months. All participants will return for clinical examination on an annual basis (though you or your doctor may require more frequent visits). You will be in the study for at least two years. You will be reimbursed for your time. Your contribution, through your participation, will help us understand the best treatment options for adults with lumbar scoliosis.
Why should “I (the patient)” enroll in this study?
· There are operative and nonoperative treatment options, all geared to help you.
· There are no experimental treatments or techniques being used and all treatments are state of the art.
· Not only will you benefit from the best care available, your contributions will benefit future generations of patients with similar spine conditions and similar health care decisions, especially if you randomize.
· You are reimbursed for your time.
For additional information, please contact:
· Christine Baldus, Project Manager, at 314-747-2655 or firstname.lastname@example.org
· Azeem Ahmad, Study Coordinator, at 314-747-2817 or email@example.com