OUTCOMES ASSESSMENT OF LOW BACK PAIN

Participants: G. Graziano, S. Papadapolous, M. L. Greenfield, S. Grube, A. Clotfelter. M. Rausch

Keywords: low back surgery, outcomes, computer software

Introduction

This study is a Beta site study for testing software for low back pain outcomes assessment in patients having low back surgery. Adult patients who are being considered for lumbar spinal surgery will be invited to participate in this study. Patients will be recruited from the Orthopaedic Outpatient Clinic and Neurosurgery Outpatient Clinic at the University of Michigan in Taubman Center.

Materials and Methods

Patients will complete the SF 36, and two brief Patient Satisfaction Questionnaires preoperatively; at two weeks postoperatively patients will complete two brief Patient Satisfaction Questionnaires; at 6, 12, and 24 months patients will complete the SF-36 and one brief Patient Satisfaction Questionnaire.

All study questionnaires are confidential and, once within the database assessment system, will be downloaded to diskette and sent to the sponsor once a month during the first two years of the study. After study completion, patient names and identifiers will be removed from all study documents that have been sent for benchmarking purposes. (Selected data items, with physician and patient identifiers removed, will be compared among the other Beta sites, and reports will be sent to each of the sites showing the comparative data.)

Progress

A total of 62 patients have been enrolled in the study.