The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.

All available treated patients at Month 6.

Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).

All available participants at Month 6.

Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.

All available participants were analyzed at six months.