Ron Donelson, MD, MSSelfCare First, LLC

Directional Preference:Classification through

Mechanical Assessment

Matched DirectionalExercises +

Postures, Remains better

Matched DirectionalExercises +

Postures, Remains better

Trunk StabilizationTrunk Stabilization

Patient Specific Functional Reactivation

Patient Specific Functional Reactivation

NN

Functional Optimization: Quota

based exercise

Functional Optimization: Quota

based exercise

NN

YY

NN

YY

Red Flags?Red

Flags?

YY

Enter

Enter

Motor Control RestorationMotor Control Restoration

YY

NN

Independent Management

Surgical/Interventional Appropriate Candidate?Surgical/Interventional Appropriate Candidate?

YY

NN

NN

Adjunct Treatments

PRN

Active Rest, Activity

Modification CBT, FRP,

Manual Therapy

Classification through Mechanical Assessment

and Diagnosis

What I’ll cover:Context: Four challenges with our spine care dilemma. Where do we need to go?

Directional preference: How it’s determined; Reliability and validity evidence; Why is it first in the algorithm?

How does it impact the remaining algorithm and future research?

Mafi et al (2013) – National Ambulatory and Hospital Medical

Care Survey: An acceleration of the development of chronic pain, work disability, more opioid prescriptions and narcotic addiction, use of injections and surgery, and guideline-discordant care.

“U.S. Spine Care System ina State of Continuing Decline”

(BackLetter, Oct 2013)

Context: Our Dilemma#1

Mafi J, McCarthy E, Davis R, BE L. Worsening trends in the managementand treatment of back pain. JAMA Intern Med. 2013

A huge effort has been invested to improve RCT design and the Levels of Evidence research construct:

1. Systematic reviews typically conclude: “insufficient evidence”, “more research must be done”

2. Many treatments persist with little supportive evidence

3. Spine care costs keep increasing with no evidence of better outcomes

WHY?

Every process is perfectly designedto get the results it gets.

Paul Batalden

Insanity: doing the same thing overand over again and expecting

different results.Albert Einstein.

“There is so much variability in making a diagnosis that this initial step routinely introduces inaccuracies which are then

further confounded with each succeeding step in care.”

Quebec Task Force Report:

Spitzer, et al: Scientific approach to the assessment and management of activity-related spinal disorders (The Quebec Task Force). Spine, 1987. 12(7S): p. S16-21.

Context: A Fundamental Shortcoming#2

The diagnosis “is the fundamental source of error….. Faced with

uncertainty, physicians become inventive.”

Spitzer, et al: Scientific approach to the assessment and management of activity-related spinal disorders (The Quebec Task Force). Spine, 1987. 12(7S): p. S16-21.

Quebec Task Force Report:

#2Context: A Basic Clinical Shortcoming

ConventionalClinical

Examination

Red FlagsTumor

InfectionFracture

HNP’s w/Neuro Deficit

All Others!(Non-specific)

MuscleHNP

Inflammation

LigamentSI Joint

Subluxation

Facet Spondys

Internal Disc

“Black Box” Classification

“Diagnostic Triage”

“The fundamental source of error.”

QTF Report

85%Clinical Guidelines?

Intuitive Empirical Precision medicine

Context: A Glimpse at the Solution

• Intuitive: highly trained professionals solve med. problems through intuitive experimentation (“Experience-Based Medicine”)

• Empirical: data amassed to show certain ways of treating patients on average (“Evidence-B medicine”)

• Precision: diseases diagnosed precisely; standardized, predictably effective treatment that addresses the cause, not the symptom(Diagnosis-Based medicine”)

#3

Convent’lClinicalExam

Red flags

HNP

Non-SpecificLBP

Our most precise anatomic diagnosis….

But how precise is it?There is no standardized

predictably-effective treatment.

How precise are our diagnoses now?

85%

Our dilemma

85% - no diagnosis

10% - anatomic diagnosis, but it’s imprecise

Need a paradigm shift!

RCTsGuidelines

Levels of Evidence

Yet spine careis in decline!

The best treatment for

NS-symptom?

Two surveys of international LBP researchers:

#1 LBP research priority:

Identifying and validatingLBP subgroups

Borkan, et al: A report from the second international forum for primary care research on low back pain: reexamining priorities. Spine. 1998 Costa, et al: Are we making progress? Spine, 2012

#4

T-O Link

D-T Link

A-D Link

A-D-T-O Research Model for Validating Subgroups

Assessment

Diagnosis

Treatment

OutcomeSubgroup RCTs: Which is the best treatment?Prospective subgrp cohorts: Does subgroup-specific treatment improve outcomes? Reliability studies: ∙ test findings ∙ subgroup classification

Kevin Spratt, AAOS 2003

RCTs that target NS-LBPare “doomed”.

To validate diagnostic subgroups that enhance individualized care……

Matched DirectionalExercises +

Postures, Remains better

Matched DirectionalExercises +

Postures, Remains better

Trunk StabilizationTrunk Stabilization

Patient Specific Functional Reactivation

Patient Specific Functional Reactivation

NN

Functional Optimization: Quota

based exercise

Functional Optimization: Quota

based exercise

NN

YY

NN

YY

Red Flags?Red

Flags?

YY

Enter

Enter

Motor Control RestorationMotor Control Restoration

YY

NN

Independent Management

Surgical/Interventional Appropriate Candidate?Surgical/Interventional Appropriate Candidate?

YY

NN

NN

Adjunct Treatments

PRN

Active Rest, Activity

Modification CBT, FRP,

Manual Therapy

Classification through

Mechanical Assessment

and Diagnosis

MDT - a dynamic mechanical test-drive:patients perform standardized end-range spine bendingand loading tests to see how the symptoms respond.

Reproducible response patterns characterize & classify the underlying problem into mechanical subgroups:

• most have subgroup-specific mechanical treatments• others have objective indications for other diagnostics

How would your car mechanic evaluate your car?A history A test-drive

Mechanical Diagnosis & Therapy (MDT):

Key: perform movements repeatedly and to end-range.

Directional Preference Reduce Centralize Abolish

MDT

Directional Vulnerability Produce Increase Peripheralize

Monitor Pain Response Relatedto Directional Loading StrategiesMonitor Pain Response Related

to Directional Loading Strategies

Insight: persistence / recurrences

Single direction

“Rapidly Reversible LBP”

Lateral

2

Flexion3

Extension

1

Prevalence of dir. pref. & centralization:

Donelson(Spine 1990) 84-89 %Sufka (JOSPT, 1998) 60-83 %Werneke (Spine, 1999) 77 %Karas (Phys. Ther. 1997) 73 %Donelson(Spine 1991, ISSLS 1991) 58 %Delitto (Phys. Ther. 1993) 61 %Erhard (Phys. Ther. 1995) 55 %Kopp (CORR, 1986) 52 %Long (Spine, 1995) 43 %Donelson (Spine ,1997) 49 %Laslett (Spine Jrnl, 2005) 32 %

Acute

Chronic

How common is dir. pref.: a reducible derangement?

Acute, ChronicAxial pain, SciaticaDegenerative disc

Pseudo-claudicationSpondys

• Rapid recovery from current episode• Decreased recurrences (50-70% first yr)

– not well-documented in the literature….yet– Where recurrence prevention is rewarded:

payers’ claims data of 5,000 patients shows that re-utilization of services after MDT care: <10%

• Immense cost savings

What is the Treatment for a Dir. Pref?

Matching Directional Exercises, Posture, Education

The underlying pain-generator is:

1. mechanical

2. reversible (mechanically, directional, & lasting)

3. likely something displaced (a “derangement”)

DP and centralization:clues that help make a diagnosis

A derangement:a “patho-mechanical” diagnosis

2 types are identified by mechanical testing:– Reducible: a directional preference that centralizes

the pain and restores full motion – Irreducible: no centralization or dir. pref.;

every direction of testing increases or peripheralizes the pain

Patho-Anatomic vs. Patho-Mechanical Diagnosis?

Patho-Anatomic Diagnosis:

1. disc herniation: MRI can’t differentiate betw a painful and non-painful finding.

2. even if it is: a. only 10% of LBP population; b. “imprecise”: doesn’t identify a standardized, effective treatment.

Patho-Anatomic Diagnosis (reducible derangement):Reliable dx: a. 70-89% of population; b. the treatment is standardized and predictably-effective.

The Use of Lumbar Extension in the Evaluation and Treatment of Patients with Acute Herniated Nucleus

Pulposus: A Preliminary Report

Anatomic AND mechanical diagnosis:

Kopp, Alexander, et.al. CORR 202:211-8, 1986

Trial of Extension

67 pts. w/ sciatica + neural deficits

33 (48%) irreversible

32 under-went surgery

2-5 day: all 34 pain-free; no surgery

Extension: 3-4 sessions/day

34 (52%) reversible

Same anatomic dx: 52% reducible, 48% irreducible der’tsIf fully tested, 10-15% more had a dir. pref.

Pt. Type Resolved Improved No Chge Worse

Duration Acute (13%) 90% 10% 0% 0%

Subacute (32%) 44.5% 52% 3.5% 0%

Chronic (55%) 32% 59% 9% 0%

Location LBP-only (47%) 51% 49% 0% 0%

Thigh (18%) 42% 50% 8% 0%

Leg/Foot (17%) 42% 50% 8% 0%

NeuroLoss (17%) 33% 50% 17% 0%

Treating Dir. Pref. (N = 72) with 2 weeks of matching exercises

Donelson R, Long A, Spratt K, Fung: Influence of DP on two clinical dichotomies: acute versus chronic pain and axial low back pain versus sciatica. PM&R, 2012

A-D D-T T-O Construct

Reliability Predictive Validity RCTs Disc ModelSpratt – 90 Kopp – 86 Karas - 97 Schenk - 03 Kopp – 86

Kilby – 90 Williams – 91 Donelson – 97 Fritz - 03 Donelson – 90

Spratt – 93 Donelson – 90 Snook – 98 Long – 04 Alexander – 92

Riddle - 94 Donelson – 91 Sufka – 98 Brennan – 06 Spratt – 93

Wilson – 99 Delitto - 93 Werneke - 99 Browder - 07 Donelson – 97

Fritz - 00 Spratt – 93 Werneke – 01 Kilpikoski - 09 Snook – 98

Razmjou – 00 Erhard - 94 Larson - 02 Petersen - 10 Derby – 00

Werneke – 01 Long – 95 Oliver - 10 Guzy - 11 Laslett – 05

Kilpikoski - 02 Scannell - 09

Clare - 04 8 Alexander - 12

Fritz - 06

11

168

10

Reducible Derangement (DP/Cent’n) Literature

9: Formal MDT training:Kappa = 0.9, 0.823, 0.7

% agreement: 88-100%2: Little MDT training: Kappa = .2 to .4

A-D D-T T-O Construct

Reliability Predictive Validity RCTs Disc ModelSpratt – 90 Kopp – 86 Karas - 97 Schenk - 03 Kopp – 86

Kilby – 90 Williams – 91 Donelson – 97 Fritz - 03 Donelson – 90

Spratt – 93 Donelson – 90 Snook – 98 Long – 04 Alexander – 92

Riddle - 94 Donelson – 91 Sufka – 98 Brennan – 06 Spratt – 93

Wilson – 99 Delitto - 93 Werneke - 99 Browder - 07 Donelson – 97

Fritz - 00 Spratt – 93 Werneke – 01 Kilpikoski - 09 Snook – 98

Razmjou – 00 Erhard - 94 Larson - 02 Petersen - 10 Derby – 00

Werneke – 01 Long – 95 Oliver - 10 Guzy - 11 Laslett – 05

Kilpikoski - 02 Scannell - 09

Clare - 04 8 Alexander - 12

Fritz - 06

11

168

10

Reducible Derangement (DP/Cent’n) Literature

Outcomes improve >7X if exercise dir. matches DP.

50% of disc surgeries avoidedAcute, chronic, axial, sciatica: rapid recoveries in 2 weeks

Outcome Prediction(D-T Link)

DP and Centralization are better than:

A-D D-T T-O Construct

Reliability Predictive Validity RCTs Disc ModelSpratt – 90 Kopp – 86 Karas - 97 Schenk - 03 Kopp – 86

Kilby – 90 Williams – 91 Donelson – 97 Fritz - 03 Donelson – 90

Spratt – 93 Donelson – 90 Snook – 98 Long – 04 Alexander – 92

Riddle - 94 Donelson – 91 Sufka – 98 Brennan – 06 Spratt – 93

Wilson – 99 Delitto - 93 Werneke - 99 Browder - 07 Donelson – 97

Fritz - 00 Spratt – 93 Werneke – 01 Kilpikoski - 09 Snook – 98

Razmjou – 00 Erhard - 94 Larson - 02 Petersen - 10 Derby – 00

Werneke – 01 Long – 95 Oliver - 10 Guzy - 11 Laslett – 05

Kilpikoski - 02 Scannell - 09

Clare - 04 8 Alexander - 12

Fritz - 06

11

168

10

Reducible Derangement (DP/Cent’n) Literature

Author

MatchingDirectional

Exercises vs. Alt.Treatments

Prev (%)

FollowUp

Subjects (N)

Pain

Function

Disability

Meds

Depression

Withdrew

/ Wors

e (%)

Brennan Manipulation 1 yr 123 +

Brennan Stabilization 1 yr 123 +

Browdr Stabilization 6 mon 48 + +

Kilpkski Manual Ther. 89 6 mon. 119 * * +

Kilpkski Advice-Only 89 6 mon. 119 + + +

Schenk Jt. Mobilztn Disch 31 + +

Long Opp. Dir’n Ex. 74 2 wks 230 + + + + 33/15

Long “Guidln-Based” 74 2 wks 230 + + + + 34/15

Petersen Manipulation 6 mon. 350 + + +

RCTs of the Directional Preference subgroup

After TESIs, MDT exam repeated

69 non-centralizers

van Helvoirt H, et. al. Transforaminal epidural steroid injections followed by Mechanical Diagnosis and Therapy to prevent surgery for lumbar disc herniation. Pain Medicine. 2014.

16% 16%

22%

46%@ 1-year: 62%

remained excellent w/o surgery

??

16%46%11%73%Non-Centralizers

underwent TESIs.

Why is Dir. Pref. Determination the First Stopin this Decision-Making Algorithm?

Strong evidence across the entire ADTO modelHigh prevalence of dir. pref. across all durations and

all LBP presentationsTreatment is highly consistent with current guidelines:

activity/movement, self-care educ’n, re-assuranceSafety: no known risk or reported complicationsMeets Christensen’s ‘precise diagnosis” definition.No question or controversy on Exer. Com.

Consequences of Starting WithDir. Pref. Determination

• The DP subgroup, successfully treated and very large, leave a much smaller subset to move to next decision point.

• Prior RCTs of NS-LBP: the DP subgroup was not excluded, so many with a dir. pref. are randomized and treated with a non-directional approach.

• Future research: should follow the ADTO model and existing subgroup evidence. First: identify/exclude those with a dir. pref.

If operating on the wrong leg is considered a “medical error”,

John Wennberg, MDDartmouth Atlas

what do we call operating on (injecting) someone who doesn’t need it?