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). 

Participant information:  The goal 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 observation) and operative treatment (spinal fusion and deformity correction surgery).  Each treatment works for most patients.

The purpose of this study is 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.  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.

Inclusion Criteria:

  • 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

Treatment options:  The best “science” method is for the patient to decide to “randomize” to operative or nonoperative care.  Randomize means participant information is entered into the computer and the computer determines the treatment you will receive.  IF the participant is assigned operative treatment, surgery is usually scheduled in the next 6 months.  IF the participant is assigned nonoperative treatment, they 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.   Our goal is to help ALL patients get better.  Our preference is for you, the patient, to decide to randomize.

Both, operative and nonoperative treatments are known to help patients.  Some participants have a STRONG preference for operative or nonoperative care.  For those patients, we do have an Observational study.  Treatments, follow-up, and all study requirements are the same, regardless if you are in the Randomized or Observational study.

Our goal is to improve ALL patients’ quality of life in this 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.  Again, our goal is to improve your quality of life and the quality of life for future patients with adult symptomatic lumbar scoliosis.  Your contribution, through your participation, will help you and others with adult lumbar scoliosis.

Why should “I (the patient)” enroll in this study?

  • You will be receiving state of the art treatment from theleadingadult deformity centers in North America.  The participating centers specialize in adult spinal deformity and are on the cutting edge of current available treatments.
  • 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.
  • All patient data is stored in a fashion that is more secure and thorough than is possible with standard clinical practice.    
  • You are reimbursed for your time.

For additional information, please contact: