Development of a person specific post-surgical rehabilitation program

1. Development of a person specific post-surgical rehabilitation program Kornelia Kulig, PhD, PT

2. A micro-topography of interventions in a randomized clinical trial.  Kornelia Kulig, PhD, PT

4. Superior Tissue to be Removed Ligamentum Flavum Intervertebral Disc Inferior Microdiscectomy --- Common Surgery for Low Back Pain with Radicular Pain

5. Are all lumbar microdiscectomies the same? • Incisions vary 1.5 cm to 4 cm • Muscular attachments are cut, or • Muscle sparing: Endoscopic technique • with muscle fiber spreading • Quality and amount of disc tissue • removed varies

6. Is the morphology of all lumbar spines undergoing a lumbar microdiscectomy the same? N = 60, 35% had => 5/7 disc rating

7. Left Right Right Left Is the morphology of all lumbar spines undergoing a lumbar microdiscectomy the same? * *

8. Success Rate, Failure Rate following a Lumbar Microdiscectomy • “success rate” continue to improve, up to 90% (Watkins et al, 2003) • •Current standard of care • does not include post-surgical • rehabilitation

9. Reported Functional Outcomes following a Lumbar Microdiscectomy •29 % microdiscectomy subjects develop back problems 1-3 years after the surgery (Kotilainen, et al 1998) • Why? • Would an Exercise Program, following the surgery, make a difference?

10. Research reports on Post Microdiscectomy Rehabilitation • 5 studies between 1993 and 2005 • number of subjects ranged from 20 to 96 • details of intervention sparsely described • length of intervention 4 to 12 weeks • follow-up 12 months or less

11. Question …. •Does a 12-week intensive strengthening and endurance exercise programresult in improvement of short term (<6-month) as well as long term (up to 5 years) outcomes?

12. Who is a candidate for a Lumbar Microdiscectomy? • Back and Leg Pain • Sex: Male and Female • Age: 18 – 60 • Occupation • Recreation

13. What is the clinical presentation following a microdiscectomy? • Symptoms • Disability • Function • Work status

14. Clinical presentation, 4 – 6 weeks following a microdiscectomy (N = 60) • SYMPTOMS: 90 % back pain; 30 % leg pain • DISABILITY(Oswestry Disability Questionnaire)

15. Clinical presentation, 4 – 6 weeks following a microdiscectomy (N = 60) • FUNCTION: 65 % have decreased performance • on walking tests • WORK STATUS: 70 % are back to work

16. Development of a person specific post-surgical rehabilitation program InceptionProtocol Training Standardization Implementation

17. Wanted:Clinical Research Protocol Amenable to: Patients who become Study Participants .. Clinicians .. Surgeons .. Researchers InceptionProtocol Training Standardization Implementation

18. Where did the protocol come from? Best available empirical evidence Methodological concerns Protocol selection Consultation with expert clinicians Goals of study InceptionProtocol Training Standardization Implementation

19. Components and Characteristics of the Clinical Intervention • Education • Exercise: • Back Extensor Endurance & Strength • Mat & Upright Exercises • Individualized, Performance based • Three sessions per week for 12 weeks InceptionProtocol Training Standardization Implementation

20. Interventions • Education: • Surgery-specific, brochure guided, individualized educational session • Follow-up quiz and feedback • All subjects receive this intervention

21. Interventions • Exercise: • Trunk Extensors Endurance and Strengthening • Symptom, Performance, and Perceived Exertion guided Progression

22. Interventions • Exercise (Mat & Upright): • Abdominal, Back, and Lower Extremity Control and Endurance • Symptom, Performance, and Perceived Exertion guided Progression

23. Training Sessions for Interventional Therapists (N = 52) • Study overview presented • Manual of procedures issued • Intervention training completed by the creators of each section: Education, Back Extensors Endurance and Strengthening, Mat & Upright Exercise • Standardization process introduced InceptionProtocol Training Standardization Implementation

24. Standardization of the Interventional Therapists(N = 27) InceptionProtocol Training Standardization Implementation • Videotapes of three sections: Education, Endurance and Strength, Mat and Upright Exercise submitted • Each section of the video was reviewed and rated by two members of the research team

25. Resources

26. Resources University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Board Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II/III Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase II Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase II 23 Outpatient Clinics, Greater Los Angeles Area

27. A person specific post-surgical rehabilitation program within a clinical trial Does it “work” in the clinics?

28. Interventions • Exercise: • Trunk Extensors Endurance and Strengthening • Symptom, Performance, and Perceived Exertion guided Progression

29. Testing 4 – 6 weeks post-surgically Symptom, Performance, and Perceived Exertion guided Testing Position 1 N = 6 (10 %) Position 3 N = 12 (20 %) Position 6 N = 39 (65 %)

30. Assessed weekly and progressed accordingly Training sequence (in 3-week periods): Strength, Endurance, Strength, Endurance

31. C-01-012-MC

33. Interventions • Exercise (Mat & Upright): • Abdominal, Back, and Lower Extremity Control and Endurance • Symptom, Performance, and Perceived Exertion guided Progression

34. 6 3 x 3 L 5 5 3 x 2 3 x 2 L 4 4 Level 3 L 3 L 3 2 L 2 1 0 1 2 3 4 5 6 7 8 9 10 11 12 L 1 Weekly Progression Rehabilitation Progression Through Squat and Lunge Exercises Post Microdiscectomy (subject C-03-012)

35. L 1 Level One

36. L 2 L 1 Level Two

37. L 3 L 2 L 1 Level Three

38. 3 x 2 L 4 L 3 L 2 L 1 Level Four

39. 3 x 3 L 5 3 x 2 L 4 L 3 L 2 L 1 Level Five

42. STUDY DESIGN • Exploratory Clinical Trial (Phase II) • Describe the constant and variable components of a replicable intervention AND a feasible protocol for comparing the intervention to an appropriate alternative

43. STUDY DESIGN • Exercise to No Exercise • “Exercise” is under the guidance of a PT in a clinical setting for 12 weeks • “No Exercise” is one session of back care education and no restriction to activity

44. STUDY DESIGN • N = 100; age 18 – 60, single level lumbar microdiscectomy

45. Current Status • 62/100 enrolled • Data collection ongoing until December 2005 • Participant satisfaction is high • Preliminary muscle morphology findings favorable

46. Acknowledgements: • Orthopaedic Clinics participating in MUSSEL • The Orthopaedic Clinical Faculty of the University of Southern California • Developers of the Standardized Intervention Program • Sean Flanagan, PhD, ATC • Andrea Lee, DPT • Ndidimaka D. Matthews, DPT • Elizabeth Poppert, MS, PT, OCS • Vera Rakic, DPT • Thomas Sutton, DPT • The Research Team • George Beneck, MS, PT, OSC • Robin Beauregard, BS • Wendy Burke, PT, DPT,MS, OCS • Allison Lamberty Bursch, DPT • Raul Lona, DPT • John Popovich, DPT, ATC • Jason Villareal, BS, ATC • Kimi Yamada, BS, ATC