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Specific physiotherapy versus advice for people

with subacute low back disorders

A randomised controlled trial Jon Ford, Andrew Hahne, Luke Surkitt, Matt Richards,

Alex Chan, Sarah Slater, Rana Hinman, Nick Taylor

3 La Trobe University

Clinical practice guidelines •  Advice/reassurance for acute/subacute LBP ±

medication for short term relief

•  Chronic LBP •  Exercise

•  Cognitive behavioural approach

•  Multi-disciplinary intervention

•  Acupuncture

•  Opiates

•  Variable recommendations for manual therapy due to lack of consistent evidence


Effect size

•  Treatment effects are small and of borderline clinical meaningfulness

•  Only when compared to “minimal intervention” or “usual care”

•  Non-significant effects comparing one treatment to another

(Dagenais et al 2010, Koes et al 2010)


Conclusion

Specific physiotherapy is effective compared to evidence-based advice

Subacute, non-compensable low back

disorders (LBD)

The differences are clinically meaningful


Classification issues

•  False assumption of sample homogeneity

•  Application of generic treatment protocols

•  Dilution of the effect of specific treatment

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7 La Trobe University 8 La Trobe University


Issues in classification based RCTs

•  Mixing populations (acute – chronic)

•  Reinventing the wheel – what about manual therapy?

•  Complexity of classification and intervention

•  Poorly described and non-reproducible treatment protocols

•  “Forcing” patients into one subgroup


Specific Treatment of Problems of the Spine

•  The right population - sub-acute, non-compensable

•  Well accepted/validated subgroups •  Reducible discogenic pain (RDP) •  Disc herniation with associated radiculopathy (DHR) •  Z-joint dysfunction (MTG) •  Non-reducible discogenic pain (NRDP) •  Multi-factorial persistent pain (MFP)

•  A sophisticated but well described and reproducible classification and treatment protocol


STOPS Randomised

Controlled Trial

DHR RDP MTG NRDP MFP


STOPS Randomised

Controlled Trial

DHR RDP MTG NRDP MFP

Subgroup specific

treatmentEvidence based

advice

Randomisation

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Evidence-based and time honoured treatment

Subgroup Specific treatment

Disc herniation and non-reducible disc

Manage inflammation, motor control, pacing/posture, pain contingent graded functional restoration, education

Reducible disc Mechanical loading strategies, pacing/posture, tape à motor control

Z-joint Unilateral manual therapy with Maitland style clinical reasoning à motor control

Multi-factorial persistent

Time contingent graded functional restoration, cognitive-behavioural approach, pain education


Aim

Evaluate the effectiveness of specific physiotherapy compared to evidence-based advice for subacute LBD classified into one of five subgroups


Design

•  Approval La Trobe University Human Ethics Committee

•  300 participants randomly allocated •  Follow-ups at 5-weeks, 10-weeks, 6-months, 12-

months, 24-months


Inclusion/exclusion criteria •  Inclusion criteria

•  Aged 18-65

•  New episode of lumbar related pain between 6 weeks and 6 months

•  Exclusion criteria

•  Compensable clients

•  Post-surgery

•  Epidural in the previous 6 weeks

•  Cauda equina syndrome


Classification process

•  Full assessment (60 minutes) •  Each individual clinical test reliable

•  Data entered into a purpose built Excel spreadsheet

•  Classification subgroup automatically calculated •  Eliminate practitioner error in classification


Intervention •  14 clinics across metropolitan Melbourne, 10 treating

physiotherapists

•  10 sessions of specific physiotherapy over 10 weeks

•  2 sessions of advice over 10 weeks (Indahl et al 1995)

•  Treatment integrity

•  240 page treatment manual

•  2 day training

•  Clinical notes submitted at 3 and 7 weeks

•  Monthly telephone hook up

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Participant Info Sheets

Diagnosis Program timeframes Treatment options Motor control training Directional preference

exercises Functional restoration

exercises Goal setting

Pacing and graded activity Increase in pain Inflammation Pain versus function Pain management strategies Posture Relaxation Sleep



Treatment protocols

•  Algorithmic, sophisticated yet reproducible •  Detailed protocols published

(Ford et al 2012a, b, c, d) •  Adhering to the key principles

(Maitland 1987, McKenzie 1981, Mayer et al 1985, Saal and Saal 1989)



Outcome measures •  Primary outcomes

•  Activity limitation (Oswestry) •  Leg pain intensity (0-10 numerical rating scale) •  Back pain intensity (0-10 numerical rating scale)

•  Secondary outcomes •  Sciatica frequency and bothersomeness scales •  Global rating of change (7-point scale) •  Satisfaction with physiotherapy treatment (and results) •  Psychosocial status (Orebro) •  Quality of life (EuroQol-5D) •  Number of work days missed •  Interference with work


Analysis

•  Between-group effects

•  Continuous outcomes

•  Linear mixed model with baseline score as a covariate

•  Ordinal outcomes

•  Mann Whitney U test

•  Dichotomous outcomes

•  Relative risk, risk difference, and number needed to treat

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Results

•  2942 volunteers screened •  300 participants recruited between

25/04/09 and 30/03/12 (10% eligibility rate)

•  16 (5%) didn’t complete the treatment •  7 (2%) didn’t complete outcome measures


Sample characteristics

•  153 men, 147 women •  Mean(SD) age of 44(12) years •  Duration of back and leg symptoms of 15(10)

and 11(10) weeks respectively


0.00

5.00

10.00

15.00

20.00

25.00

30.00

35.00

0 5 10

Osw

estry

(%)

Time (weeks)

Activity limitation

Advice

Specific physiotherapy


0.00

1.00

2.00

3.00

4.00

5.00

6.00

0 5 10

Bac

k pa

in (N

RS

)

Time (weeks)

Back pain intensity

Advice



0.00

1.00

2.00

3.00

4.00

5.00

6.00

0 5 10

Leg

pain

(NR

S)

Time (weeks)

Leg pain intensity

Advice



-1.5 -1.0 -0.5 0.0 0.5 1.0 1.5

Favours Advice Favours Specific Treatment

OSW

Back pain

leg pain

Baseline

5 weeks

10 weeks

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0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5 weeks 10 weeks

Percentage of participants improving by at least 50% on the Oswestry

Specific physiotherapy Advice

P=.233 (5 weeks) P=0.083 (10 weeks)


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5 weeks 10 weeks

Percentage of participants improving their leg pain on the NRS by at least 50% from baseline


Advice

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5 weeks 10 weeks

Percentage of participants improving their back pain on the NRS by at least 50% from baseline


Advice

P<0.001 (5 weeks) P<0.001 (10 weeks)


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5 weeks 10 weeks

Percentage of participants improving their leg pain on the NRS by at least 50% from baseline


Advice

P<0.001 (5 weeks) P<0.001 (10 weeks)


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5 weeks 10 weeks

Percentage of participants at least "much improved" on the global rating of change scale


Advice

P<0.001 (5 weeks) P<0.001 (10 weeks)


0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

5 weeks 10 weeks

Percentage of participants "very satisfied" with physiotherapy care


Advice


Discussion

•  The first high quality, classification based RCT to show moderate and clinically meaningful effects on subacute, non-compensable LBD

•  Secondary outcome measures all support the primary outcome measures

•  Low drop out and loss to follow up •  If treatment integrity measures are followed the

STOPS protocols are reproducible

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Limitations •  Development of the classification system

•  Methods for development and validation complex

•  Time honoured principles/widespread clinical use

•  Carefully constructed to concur with original authors

•  Influence of participants with PS/neurophysiological factors included in pathoanatomical subgroups

•  Lack of placebo control


Where to from here? •  Longer term follow up

•  Further analysis

•  Practitioner factors, treatment effect modifiers, predictors of outcome

•  Refinement of the classification system

•  SIJ/pelvic pain

•  Psychosocial and neurophysiological factors

•  Chronic pain

•  Placebo controlled trial


Conclusion

Specific physiotherapy is effective compared to evidence-based advice

Subacute, non-compensable LBD

The differences are clinically meaningful

Thank you

Lifecare

La Trobe University

§  Nick Taylor

§  Megan Davidson

University of Melbourne

§  Rana Hinman

§  Tania Pizzari

§  Joan McMeeken

Andrew Hahne Jon Ford Sarah Slater Luke Surkitt Matt Richards

Jus8n Moar | Aidan Rich | Daniel Di Mauro | Ross Lenssen Gabrielle Hunter | Shay Mcleod | Kerryn Dunn | Mark Opar | Joel Laing

Adam Walters | Meghan Dean | Ben Sheat

Thank you

Web: www.STOPSbackpain.com.au Facebook: www.facebook.com/STOPSbackpain Twi8er: @stopsbackpain

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stops rct ford et al 2012

Health & Medicine