AProf Jon Ford’s presentation from today at the World LBP Congress in Antwerp presenting new data on the STOPS approach, introducing STOPS Plus for more complex chronic pain and comparing clinical importance with STarT Back and Cognitive Functional Therapy

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The evolving case supporting
individualised physiotherapy for low
back pain
Associate Professor Jon Ford
PhD, Musculoskeletal Physiotherapist
Clinical and Managing Director, Advance Healthcare

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 Overview of guideline based care
 3 individualised physiotherapy approaches
 Present new data on the STOPS approach
 Compare and contrast
Today’s presentation

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 “…. prevalence and disability has increased markedly over the past 25 years (representing
a) huge and growing global burden” (Hurwitz et al 2018)
 In PEDro, over 2000 randomised controlled trials (RCTs)
– Few consistent results demonstrating clinically important effects
– Between group standardised mean difference (SMD) of >/= 0.5 (Mansournia and Altman
2018)
The LBP epidemic

4. What are we doing about it?

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Clinical guideline recommendations
Acute LBP (<6-weeks) Chronic LBP (>12-weeks)
First line care
Advice
Education
Advice
Education
Exercise
Cognitive behavioural therapy
Foster et al 2018

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 Advice (acute/chronic LBP) – no evidence to support effectiveness (Abdel Shaheed et al
2014)
 Pain education (acute LBP) – not more effective than placebo. Small and short term effect
on disability (Traeger et al 2018 RCT)
 Pain education (chronic LBP) – not effective in isolation but short term effect on disability
combined with physiotherapy (Wood et al 2019)
 Exercise (acute/chronic LBP) and cognitive-behavioural therapy (chronic LBP)
– Minimal evidence of effectiveness compared with other treatments (Hayden et al 2005,
Henschke et al 2008)
 “… important questions remain about effectiveness (and) cost-effectiveness” (Foster et al
2018)
Does first line care work?

7. Is individualised treatment the
answer?

8. Is individualised treatment the
answer?

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Hill et al 2011

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O’Sullivan et al 2018

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Assess for pathoanatomical, physical, psychological, social, lifestyle and
health related factors including Örebro Screening Tool
Identify subgroup membership relevant
to individualised treatment
Identify contributing factors relevant to
individualised treatment (Örebro)
Reducible
discogenic pain
McKenzie
approach
Z-joint
dysfunction
Specific manual
therapy
Disc injury with
likely slow
recovery
Pain contingent
graded activity &
exercise (CBT)
Non-specific LBP
with likely poor
prognosis
Time contingent
graded activity &
exercise (CBT)
eg Work
issues
Work based
intervention
eg Fear
avoidance
Relaxation,
graded exposure
eg Sleep
Problems
Sleep hygiene,
mindfulness
eg Poor
Coping
Problem solving
skills
All subgroups
except NSLBP
Specific muscle
activation of
TrA/multifidus
Management of
inflammation
= different to
STarT Back or CFT
= similar to STarT
Back or CFT

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 6 week duration central LBP due to manual handling injury, walking eases pain, Örebro
70/210, worse with sitting/bending/lifting, no significant psychosocial factors
 No response to manual therapy, generic exercise and advice to remain active
 STarT Back – low risk NSLBP  advice and minimal intervention
 CFT – low disability/complexity NSLBP  advice and minimal intervention (1-3 sessions)
 STOPS – reducible discogenic pain  McKenzie approach, specific muscle activation, pain
contingent graded activity/exercise (10 sessions)
FOR CLINICIANS – which treatment is most likely to get best compliance and results?
Case study

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2038
screened
300
randomised
Specific physiotherapy
(n=156)
Advice
(n=144)
5 weeks (98%)
10 weeks (99%)
26 weeks (97%)
12 months (94%)
5 weeks (97%)
10 weeks (95%)
26 weeks (92%)
12 months (91%)
Follow-up
Allocation

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0
1
2
3
4
5
6
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
Backpain(Numericalratingscale)
Time (weeks)
Advice
Specific physiotherapy
MD=1.3
p<0.001 MD=0.9, p=0.001
Back pain

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0
1
2
3
4
5
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
Legpain(Numericalratingscale)
Time (weeks)
Advice
Specific physiotherapy
MD=1.1
p<0.001
MD=1.0, p=0.003
Leg pain

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0
5
10
15
20
25
30
35
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
OswestryDisabilityScale
Advice
Specific physiotherapy
Time (weeks)
MD=4.7
p=0.001
MD=5.4, p<0.0001
MD=4.3, p=0.003 MD=3.1, p=0.037
Disability - Oswestry

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 Slightly more expensive (total healthcare costs) +$42
 Large cost savings when considering lost income -$3073
 $649.80 per Quality Adjusted Life Year (QALY) gained
Cost effectiveness
Hahne et al 2017

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Is that cost-effective?
Dalziel 2008, Johnsen 2013, Lin 2011, Manchikanti 2013
Disc replacement (V multidisciplinary rehab)
Discectomy (V conservative)
Statin drugs for cholesterol
NSAIDs for osteoarthritis
Adding exercise to GP care for LBP
Group CBT for LBP
Epidural injections for sciatica
Individualised physiotherapy
$64,000
$62,920
$50,000
$19,000
$18,177
$3,911
$3,146
$650

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Dalziel 2008, Johnsen 2013, Lin 2011, Manchikanti 2013
Disc replacement (V multidisciplinary rehab)
Discectomy (V conservative)
Statin drugs for cholesterol
NSAIDs for osteoarthritis
Adding exercise to GP care for LBP
Group CBT for LBP
Epidural injections for sciatica
Individualised physiotherapy
$64,000
$62,920
$50,000
$19,000
$18,177
$3,911
$3,146
$650
Australian Government willingness to
pay threshold for one QALY: $50,000

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 Specific muscle activation as part of a motor control approach
 Inflammation
 Pathoanatomy
New data relevant to STOPS

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Hides et al 2019

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 Limitations with previous reviews on specific muscle activation (SMA)
 Our systematic review
– Only included RCTs that optimised specific muscle activation in low load positions and
progressed to function
– All types of LBP included (eg non-specific, spondylolisthesis, disc herniation)
New data - does motor control (specific
muscle activation) work?
Ford et al 2019 (under review)

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 SMA vs exercise - moderate effects on short (0.53) and long term (0.64) disability
 SMA vs conservative medical management – moderate to large effects on short and long term
pain (0.7 to 1.29)
 SMA vs multi-modal physiotherapy – large effects on short and intermediate term pain and
disability (0.78 to 2.46)
 Comparisons with effect sizes < 0.5 not reported here
Does motor control (specific muscle
activation) work?
Ford et al 2019 (under review)

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 Systematic review (Riley et al 2019)
– Only included studies with moderate to high methodological quality
– No evidence to support effectiveness of movement based motor control
Does motor control (movement
retraining) work?

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 Treatment of inflammation in the STOPS RCT was mandatory before other methods (eg
manual therapy/McKenzie) in patients with the clinical features of inflammation
 No validation of these features in LBP
New data - inflammation

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 40 patients with lumbar disc herniation and radiculopathy undergoing
discectomy and 3 patients providing control discs from surgery for
scoliosis
 Measured at baseline for a range of clinical features
 Disc tissue analysed for histological evidence of inflammatory cells
 Multi-variate analysis
Diagnostic accuracy of clinical features
for inflammation in disc herniation
Ford et al 2019 (under review)

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0
1
2
3
4
E01 E03 E10 E25 E28 E40 E41 E52 E53 E62 E63
Sample Number
Cellprevalence
Macrophages
T cells
B cells
Relative prevalence of inflammatory cells in herniated disc tissue sections
Cell prevalence: 0= no cells, 1= few cells, 2= moderate cells, 3= abundant cells
Cellprevalence
0123
Sample number
Macrophages
T Cells
B Cells

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Diagnostic accuracy for inflammation
1. Clinical inflammation score +ve
2. Back pain <5/10
3. Worse the next day after injury
4. Flexion range of motion 0-30
Sensitivity 90.9%
Specificity 92.9%
LR+ 12.7
LR- 0.1
Diagnostic Odds Ratio 130.0
Correctly predicted 92.3%
N=40, 11 samples with inflammatory cells
No evidence of inflammatory cells in control discs
Ford et al 2019 (under review)
Clinical inflammation score was at least three of: constant symptoms, morning pain/stiffness greater
than 60-minutes, short walking not easing symptoms and significant night symptoms

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 Researchers and clinical practice guidelines suggest biomedical factors are not relevant in
LBP management
 Few high quality studies have evaluated biomedical or pathoanatomical factors of
prognostic value
 We completed 2 high quality prognostic studies
– 300 people from STOPS RCT
– 97 people having lumbar discectomy for disc herniation with radiculopathy
New data – biomedical and
pathoanatomical

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 Cohort of 300 from STOPS RCT
– +ve prognosis – discogenic pain, low transversus abdominis tone, disc herniation
– -ve prognosis – both parents born overseas, widespread pain, multifidus high tone,
clinical inflammation, functional capacity
 Cohort of 97 people having lumbar discectomy for disc herniation with radiculopathy
– +ve prognosis – worse with repeated extension in lying, reduced sitting tolerance,
sleeping difficulties
– -ve prognosis – compensation, crossed SLR, duration of symptoms, widespread
symptoms
Ford et al 2018 and 2019
Ford et al 2018, Ford et al 2019 (under review)

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 STOPS plus developed for more complex chronic pain (all body regions)
 More robust psychosocial questionnaires (Depression Anxiety Stress Scale, Pain
Catastrophising Scale), Pain Self Efficacy, PTSD Checklist
 Management of unhelpful postures, movements and muscle activation (motor control)
 Subgrouping by pain type (nociceptive, neuropathic and nociplastic/central sensitisation)
 Sophisticated computer based practitioner guidance to individualised treatment
 STOPS plus versus usual physiotherapy care (12 sessions)
New data – STOPS plus (n=40 pilot RCT)

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 Underpowered to report on statistical significance
 Threshold used by computer model to determine nociplastic vs nociceptive suboptimal
(misclassification rate high). Small to moderate effects still seen at 6 months
 Moderate to large effects on neuropathic pain (treated with anti-inflammatory treatment
and pain contingent functional restoration with motor control)
Results
3 months (SMD) 6 months (SMD) 12 months (SMD)
Oswestry 0.7 1.4 0.5
Back pain 0.9 0.6 0.9
Leg pain 1.4 1.8 2.0

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Comparing individualised
physiotherapy approaches

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 Between group differences are important (effect sizes of >/= 0.5)
– Commonly cited MCID not intended for group data
 Consistency of effect across outcomes (particularly pain and disability)
 Cost effectiveness
 More than 1 trial with consistent findings
 Treatment acceptable to most patients - high rates of treatment completion
 Consider control group recovery trajectories
Clinically important differences
Mansournia and Altman 2018, Deyo et al 2014

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 STarT Back RCT (Hill et al 2011)
– Small effects on disability
– No effect on pain
– Some economic benefits based on reduced “unnecessary” treatment
 Other studies
– RCT replication study (Morso et al 2018)
– Implementation studies across the Northern hemisphere underway (Bamford et al 2017,
Miller et al 2017,Hsu et al 2019, Abbott et al 2018)
Clinically important differences?

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 Cognitive Functional Therapy RCT (Vibe Fersum et al 2011)
– Moderate to large effects on pain and disability
– 30% treatment non-completion and loss to follow up
– No intention to treat analysis. No cost effectiveness analysis
 O’Keeffe et al 2019
– RCT replication study
– 37% treatment non-completion
– Small effects on disability with intention to treat
– Planned cost effectiveness analysis not completed
Clinically important differences?

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Control group recovery trajectories - Travers et al
2018 BJSM editorial critical of STOPS

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Figure 2 from Travers et al 2018 comparing STOPS with Costa recovery
trajectories using acute LBP data (< 6 weeks) – invalid comparison given
STOPS recruited 6 weeks to 6 months post injury

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Correct comparison of recovery trajectories using STOPS advice group and
Costa recovery trajectories of patients with a similar duration of symptoms
(Ford et al 2018)

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 NOT valid to compare RCT recovery trajectories in determining superior treatment
– Only valid method is direct comparison in RCTs to control for all factors
 However side by side comparison can tell an interesting story
 An important consideration is the control group recovery trajectory (as most patients
improve when in clinical trials)
Clinically important differences and
comparing recovery trajectories
Costa et al 2012

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Backpainscore(0-10)
0
1
2
3
4
5
6
7
Baseline Short term
(around 3 months)
Intermediate term
(around 6 months)
Long term
(around 12 months)
STOPS intervention STOPS advice
STarT Back intervention STarT Back usual care
CFT intervention CFT group treatment

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Clinically important findings?
Effects
>/= 0.5
Improving pain
and disability
Cost
effective
Sound RCT
method
(PEDro > 5)
> 1 RCT
with
consistent
results
Treatment
completion/
Loss to
follow up
Control
recovery
trajectory
STarT
Back 
P
D
 6   
Cognitive
Functional
Therapy
Var Var ?
5
6
Var  
STOPS Var   7   

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 LBP is a massive public health problem
 LBP is complex and multi-factorial
 Given over 2000 RCTs evaluating non-individualised treatment (PEDro) it is likely that most
treatments are equivalent in effect when applied in that manner
Things we know

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 We don’t know which factors (pathoanatomical, physical, psychological, social, genetic) are
more/less important. Premature to discount the relevance of pathoanatomy
 We think individualised treatment may be more effective than non-individualised treatment
but there is insufficient data to be conclusive
Things we are uncertain of

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 Clinical reasoning processes to negotiate the complexity of individualised physiotherapy
for LBP
 Protocols such as the STOPS approach may be a way of operationalising clinical reasoning
to optimise effect sizes in clinical trials
Things to evaluate in the future

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Thank you… and see you in Melbourne!
Acknowledgements : Dr Andrew Hahne, Dr Alex Chan, Luke Surkitt,
Matt Richards, Shannon Bower, Arun Belasundaram, Bella Ford