A Multi-Center Study Evaluating the Efficacy of Spinal Cord Stimulation (SCS) for Axial Low Back Pain

Jim Thacker MS; Todd Gross PhD; Allison Foster PhD; for the Axial Low Back Pain Study Group
Clinical Research, Boston Scientific, Valencia, CA 91355

INTRODUCTION
Spinal cord stimulation (SCS) e ectively manages a range of painful etiologies, but little published evidence supports its use for axial low back pain. 1, 2 Here we present preliminary outcomes of a prospective, multi-institutional clinical trial designed to assess the therapeutic value of SCS in treating axial back pain associated with failed back surgery syndrome (FBSS). This studys axial low back pain cohort had all failed more conservative therapy and as such should be considered very di cult to treat.

RESULTS
Demographic Summary and Study Status Subjects Enrolled Sites Enrolling Age Gender Ethnicity Duration of Disability 259 25 56.4 +/- 14.2 years, Range: 28 82 50.4% Female 97% Caucasian, 3% African-American 14.0 +/- 14.0 years, Range: 1 68 45% Medicare/Medicaid; 35% HMO/PPO; 12% Workers Compensation; 7% Other; 1% Federal /Railroad Outcomes of Temporary Trial Temporary Trials Completed 226 172 (76.1%) 159 (92.4%)

STUDY SUMMARY This large, multi-center study was conducted under conditions of high ecological
validity.

Subjects demonstrated very high success rate of temporary stimulation trials

(76.1%) and of conversion to permanent implants (92.4%).

Reasons for withdrawal included patient choice, lack of insurance, and lost to
follow-up.

Self-reported pain ratings (0 to 10 scale) dropped signi cantly from baseline

Study Purpose
to assess the acute and chronic e ectiveness of the Precision SCS System in subjects with Failed Back Surgery Syndrome and associated low back (axial) pain.

follwing the temporary stimulation trial (6.6 vs. 3.9, p < 0.0001). Subjects reported, on average, a 40% decrease. treating a long-term disabled and refractory axial back pain population.

Type of Insurance

The responder rate was unexpectedly high, given the challenges inherent to Preliminary data suggest that long term pain reduction is maintained and is
consistent with that observed during the temporary trial. These data will be reported when all subjects have completed 12 month follow up later this year.

METHODS
Subjects with FBSS and a primary complaint of axial low back pain were implanted with one or two epidural percutaneous SCS leads and an external trial stimulator (Precision, Advanced Bionics). After a 5-10 day trial, outcomes were assessed; subjects who reported a signi cant reduction in pain during the trial and were considered appropriate clinical candidates by their physician were considered to have had successful trials. Most subjects with successful trials went on to implant of a permanent Precision system according to standard clinical practice. After activation of the permanent SCS system, pain, disability (Oswestry disability scale), quality of life (EQ5D), medical satisfaction, and other assessments (Battery for Health Improvement II [BHI II] and Brief Battery for Health Improvement [BBHI]) were gathered at 3, 6, and 12 months and compared to baseline measures. Also collected were data regarding health care utilization including pain medication use. Additional assessments were made at 3.5 months after a 2-week period of no stimulation. The owchart below schematizes the study schedule and assessments.

Successful Trials Permanent Implants Conversion Rate

Axial Back Pain Improves During SCS Trial Period

10 9 8 7 6 5 4 3 2 1 0

DISCUSSION
This study represents the largest prospective experience reported to date for SCS in axial low back pain. 2 Careful patient selection and stimulation programming can improve capture of the axial low back with SCS and improve trial-to-permanent conversion rates. The high percentage of successful SCS trials in this study suggests that the technological capabilities of Precision, particularly fractionalized current across contacts, may uniquely provide the type of stimulation needed to relieve axial back pain. These encouraging data support the use of Precision SCS in this very di cult to treat population who have exhausted other options for e ective therapy.

Pain Rating (0 - 10; Momentary Recall)

p<0.0001

Baseline
14 12 10 8 6 4 2 0 -100 -80 -60 -40 -20 0

Temporary Trial REFERENCES AND ACKNOWLEDGEMENTS

Physician investigators who participated in this study group are: Aalaei B, Bennett D, Benyamin R, Boyd E, Brendel J, Elborno A, Flinders C, Hurdle M, Jobalia N, Khan Y, King TE, Kosek P, Maurer P, Oakley J, Raso L, Rauck RL, Rosenthal R, Schabacker M, Simopoulos T, Smith K, Stauss T, Varga C, Yearwood T.
1. North RB, Kidd DH, Olin J, Sieracki JM, et al. Spinal cord stimulation for axial low back pain: a prospective, con trolled trial comparing dual with single percutaneous electrodes. Spine. 2005;30(12):14121418. 2. Barolat G, Oakley JC, Law JD, North, RB, Ketcik B, Sharan A. Epidural spinal cord stimulation with a multiple

Baseline

Post OR Trial Fitting

End of Trial

Permanent Implant

3 Month Visit

3.5 Month Visit

6 Month Visit

12 Month Visit

Pain RatingsP BBHI; Momentary Pain BHI II: Oswestry; EQ5D

Percent of Subjects

20

40

60

80

100

electrode paddle lead is e ective in treating intractable low back pain. Neuromod. 2001;4(2):59-66.

Pain Reduction (%)

This study was sponsored by Boston Scienti c/Advanced Bionics.