Intrathecal Drug Delivery Systems: Efficacy and Stability Over Time

1. Intrathecal Drug Delivery Systems: Efficacy and Stability Over Time Eric A. Seemann, Ph.D. K. Dean Willis, M.D. J. Michael George, Psy.D. Marie L. Mueller. B.A. Kay Harden David Stephenson, B.S. Leah Pinkerton, RN, MSN The Alabama Pain Center The University of Alabama in Huntsville

2. Introduction • IDDS Treatment Stability • Axis II Psych Symptoms • Psychomedical Complaints • Somatization • Conversion • Hypochondriasis

3. Hypotheses • H1: IDDS treatment is stable over time. • H2: Patients with Axis II Symptoms • Fewer overall gains • Treatment is less stable over time • H3: Patients with Psychomedical Complaints • Report less satisfaction with care • Unrelated to actual pain relief

4. Methods Participants • Employment • 62% Disability • 20% Retired • 10% Unemployed • 8% Full or Part-time • Marital Status • 66% Married • 14% Widowed • 11% Divorced • 8% Single • 1% Separated • N = 65 • Age • M= 58.46 • Gender • 59% Female • 41% Male • Race • 92% Caucasian • 8% African American

5. Methods Design Statistics • Archival Study • Within Subjects Design • Psych Screen • PAI • BBHI-2 • MBMD • Repeated Measures ANOVA with covariance analysis • Correlation • Between Subjects ANOVAs

6. Results • Pain Score F(3, 189) = 5.02, MSE= 2.39, p = .002 • Pain Score L1 vs. L2F(1, 163) = 11.78, p = .001 L2 vs. L3F(1, 163) = 7.32, p = .009 L3 vs. L4F(1, 163) = .033, p = NS *L1=Baseline *L2= 6 wks Post-implant *L3= Midpoint in Treatment *L4= Last Recorded Visit

7. Results • Pain Score * Axis II Elevation F(3, 189)= 3.49, MSE= 2.39, p = .017 • Pain Score * Axis II Elevation L1 vs. L2 F(1, 163) = 1.19, p= NS L2 vs. L3 F(1, 163) = 6.72, p= .012 L3 vs. L4 F(1, 163) = .017, p= NS *L1=Baseline *L2= 6 wks Post-implant *L3= Midpoint in Treatment *L4= Last Recorded Visit

8. Results

9. Results • SOM x 6 Weeks Visit: F (1, 63) = .116, p = NS • SOM x Half-way Visit: F (1, 63) = .000, p = NS • SOM x Last Visit: F (1, 63) = 9.733, p = .003

10. Results

11. Discussion • IDDS Demonstrates Efficacy & Stability • Axis II Elevation & Increasing Pain Score • Psychomedical Complaints & Dissatisfaction

12. Questions? Krames, E. (2002) Implantable Devices for Pain Control: Spinal Cord Stimulation and Intrathecal Therapies. Best Practice & Research Clinical Anesthesiology, 16, 619-649 Belverud, S., Mogliner, A., Shulder (2008) Intrathecal Pumps. The American Society for Experimental NeuroTherapeutics, 5, 114-122 Kumar, K., Kelly, M., Pirlot, T., (2001) Continuous Intrathecal Morphine Treatment for Chronic Pain of Nonmalignant Etiology: Long Term Benefits and Efficacy. Surg Neurol, 55, 79-88 Manchikanti, L., Singh, V., Helm, S., Schultz, D.M., Datta, S., Hirsch, J. (2009) An Introduction to an Evidence-Based Approach to Interventional Techniques in the Management of Chronic Spinal Pain. Pain Physician, 12, E1-E33 Deer T.R., Smith, H.S., Cousins, M., Doleys, D.M., Levy, R.M., Rathmell, J.P., Staats, P.S., Wallace, M., Webster, L.R. (2010) Consensus Guidelines for the Selection and Implantation of Patients with Noncancer Pain for Intrathecal Drug Delivery. Pain Physician, 13, E175-E213 Ekselius, L., Von Knorring, L., Enskog, J., Ordeberg, G. (1996) Effects of Personality Disorders on Treatment Outcome of Surgery of Low Back Pain. Journal of Musculoskeletal Pain, 4, 87-96 Dohrenwend, A., Skillings, J.L. (2009) Diagnosis-Specific Management of Somatoform Diseases: Moving Beyond “Vague Complaints of Pain”. The Journal of Pain, 10, 1128-1137 Lebovits, A. (2007). Cognitive-behavioral approaches to chronic pain. Primary Psychiatry, 14, 48-54.