Development of a person specific postsurgical rehabilitation program

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Development of a person specific post-surgical
rehabilitation program  

• Kornelia Kulig, PhD, PT

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A micro-topography of interventions in a
randomized clinical trial. 

• Kornelia Kulig, PhD, PT

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Microdiscectomy --- Common Surgery for Low Back
Pain with Radicular Pain
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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

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Is the morphology of all lumbar spines undergoing
a lumbar microdiscectomy the same?
N 60, 35 had gt 5/7 disc rating
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Is the morphology of all lumbar spines undergoing
a lumbar microdiscectomy the same?


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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
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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?

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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

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Question .

• Does a 12-week intensive strengthening and
  endurance exercise program result in improvement
  of short term (lt6-month) as well as long term (up
  to 5 years) outcomes?

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Who is a candidate for a Lumbar Microdiscectomy?

• Back and Leg Pain
• Sex Male and Female
• Age 18 60
• Occupation
• Recreation

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What is the clinical presentation following a
microdiscectomy?

• Symptoms
• Disability
• Function
• Work status

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Clinical presentation, 4 6 weeks following a
microdiscectomy (N 60)

• SYMPTOMS 90 back pain 30 leg pain

• DISABILITY (Oswestry Disability Questionnaire)

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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

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• Development of a
• person specific
• post-surgical rehabilitation program

Inception Protocol Training
Standardization Implementation
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Wanted Clinical Research Protocol

• Amenable to
• Patients who become Study Participants ..
• Clinicians .. Surgeons ..
• Researchers

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

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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

Inception Protocol Training
Standardization Implementation
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Interventions

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

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Interventions

• Exercise
• Trunk Extensors Endurance and Strengthening
• Symptom, Performance, and Perceived Exertion
  guided Progression

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Interventions

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

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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

• Inception Protocol Training
  Standardization Implementation

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Standardization of the Interventional Therapists
(N 27)

• 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

• Inception Protocol Training
  Standardization Implementation

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Resources
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University of Southern California Biokinesiology
and Physical Therapy Department Coordinating
Center
Resources
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
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A person specific post-surgical rehabilitation
program within a clinical trial 

• Does it work in the clinics?

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Interventions

• Exercise
• Trunk Extensors Endurance and Strengthening
• Symptom, Performance, and Perceived Exertion
  guided Progression

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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 )
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Assessed weekly and progressed accordingly Traini
ng sequence (in 3-week periods) Strength,
Endurance, Strength, Endurance
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C-01-012-MC
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(No Transcript)
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Interventions

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

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Rehabilitation Progression Through Squat and
Lunge Exercises Post Microdiscectomy (subject
C-03-012)
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Level One
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Level Two
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Level Three
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Level Four
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Level Five
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(No Transcript)
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(No Transcript)
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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

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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

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STUDY DESIGN

• N 100 age 18 60,
• single level lumbar microdiscectomy

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Current Status

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

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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

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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