Evidence informed

osteopathic care:

Challenges and opportunities

Dr Jorge Esteves, PhD, MA, BSc, DO

Head of Research BSO

Aims

• Review EBM principles and practical delivery

• Consider challenges and limitations of EBM

• Discuss the EBM and EIP in the context of osteopathy and its current evidence base

• Common challenges to areas of osteopathic practice

• Identify resources

Background

• Archie Cochrane identified need to

synthesise research – Cochrane

collaboration

• Paul Sackett & Gordon Guyatt developed

ideas

• Aim to enhance quality of care – safety and

effectiveness

– Equity and cost effectiveness

Evidence-Based Medicine (EBM)

‘the conscientious, explicit and judicious use

of the current best evidence in making

decisions about the care of individual

patients….integrating individual clinical

experience with the best available external

clinical evidence from systematic research’ Sackett et al. (1997)

Evidence-Based Medicine (EBM)

Individual

clinical

expertise

Best available

external

clinical

evidence

…with

consideration

of patient

values &

expectations

“Evidence-based medicine is the integration of best research

evidence with clinical expertise and patient values”(Sackett 1996)

EBM

Process

1. Identify a question

2. Efficient identification of the relevant

literature

3. Appraise for validity and applicability

4. Synthesise

5. Combine with expertise and apply results

with patient

6. …. Evaluate outcome?

Questions

• Nature of the question

– Effectiveness

– Prognostic factors

– Diagnostic factors etc

What kind of research designs are associated with the best

evidence for these types of questions?

Structuring questions to help

searches: Effectiveness

• Population

• Intervention

• Comparator

• Outcome

Question Population Intervention Compari

sons

Outcomes

What is the

effectiveness

of manual

therapies

compared

with usual

care on

functional

disability,

pain, or

distress

Adults

presenting

with non

specific

back pain >

than 6

weeks

duration

and < one

year

Manual

therapies

Usual

care

Disability

scores

Pain

scores

Psych.

distress

NICE guideline

Searching the literature

• Construct search strategy

– Map to PICO

– Inclusion and exclusions • Design, conditions, outcomes etc

– Several data bases (PubMed, Cinahl, Embase, Amed etc

• Search

– Remove duplicates

– Include exclude

Appraisal

• Critically appraise dependent on question

and types of evidence for example:

– Quality: risk of bias

– Applicability: external validity

Synthesise

• Pull information together and produce

evidence statements or summarise for

own practice and identify actions, changes

in behaviour etc

Apply results

• Combine with own expertise and patient’s

preferences in clinical encounter to inform

best practice

Assumptions?

• What are the challenges and obstacles to

this process

MSc Osteopathy 2013

EBM - Hierarchy of evidence

EBM A small body of

supporting research

in ‘high’ end

Most clinical

evidence in

mid-low end

Much evidence on OMM

in basic science

establishing plausibility

of mechanisms

Hierarchies and all that…

• Relate to type of question being asked

• Make things easier for:

– Policy makers

– Reviewers

– Guideline writers

– Insurers

But…

• The issue of strength of evidence is not

simple or uncontested

– RCTs

• Highly controlled

• Specific recruitment and exclusion

• External validity of intervention and trial

• Funding, publication and design bias

• Challenges with complex interventions

• Rarely simple single conditions

Using the information

• From population to the individual

• New authoritarian paternalism

– Perceived threat to autonomy of patients and

practitioners

• Skills to search, skills to appraise, skills to

synthesise

• Time away from patients

Osteopathy and manual therapy

context

• Most areas there is not good quality

evidence

• Anecdote and expert opinion plays a large

part in our practice

– Personal experience has a big influence

– Identify and listen to experts

– Face to face bigger impact than guidelines

Current Osteopathic Practice?

Patient Values

&

Expectations

Individual Clinical

Expertise

Best

External

Evidenc

e

Best

External

Evidence

Little difference with

other manual therapies

or medicine … but

things are changing

Many fear this is the direction of EBM

…with mistrust of the generalisability

of RCTs to all patients

Patient

Values &

Expectati

ons

Individual

Clinical

Expertise

Best

External Evidence

EBM

The future of osteopathy…

What will this transformation look like?

What will be lost?

Will Osteopathy lose its soul?

The aim of research and EBM is to improve patient care

Welcome the opportunity for science to add to current knowledge

Should consider ‘losing’ aspects when there is unequivocal

evidence to do so

MSc Osteopathy 2013

‘Evidence-informed osteopathy’

• EBM semantics?

• In osteopathic practice, a strict adherence to EBM is not possible due to a lack of high-quality evidence

• Better terminology is ‘evidence-informed practice’ (Haldeman & Dagenais 2008) or ‘evidence-informed osteopathy’ (Fryer 2007, 2010)

Guiding principles behind evidence-informed practice are:

• use of research evidence when available

• followed by personal recommendations based on clinical

experience

• retaining a transparency about the process used to reach clinical

decisions (Haldeman & Dagenais 2008)

What’s the alternative?

• Non evidence based or un-informed osteopathy?

– Risk of marginalisation

– Inability to respond to expectations of: • Regulator

• Policy makers

• Peer professions

• Public

• Students

• Insurers etc

Challenges to address in osteopathy

• Outcomes of treatment

– Effectiveness and cost effectiveness

• Diagnosis

– Validity and reliability of our clinical

evaluations

• Mechanisms

– Basic science to evaluate the underlying

processes that mediate our treatment effects

Challenges to address in osteopathy

• Plausibility of our conceptual models

– Appraise, revise and enhance the conceptual

models that currently underpin osteopathic

practice

Evidence of effectiveness of OMT

• LBP has been studied more than any other condition

• Andersson et al (1999) N Engl J Med. 341:1426-1431. – RCT (N=155) OMT & standard care – Both groups improved during12 weeks; not statistically significant for any of the

primary outcome measures. – The osteopathic-treatment group required significantly less medication

(analgesics, antiinflammatory agents, and muscle relaxants) and used less physical therapy

• Burton et al (2000). Eur Spine J, 9:202-207.

– Manipulation produced a statistically significant greater improvement for back pain and disability in the first few weeks

– No statistically significant difference in outcome between the treatments at 12 months

• Williams et al. (2003) (ROMANS) Family Practice 20(6)

– Medium RCT (N=201), OMT & usual GP care – Pain less for OMT at 2 months, not at 6 months – Psychological outcomes (SF-12) better at 2 & 6th months

• UK BEAM Trial (2003) – Treatment package agreed by UK osteopaths, chiropractors & physiotherapists

– Large (N=1334) RCT, manipulation, standard medical care, exercise

– Relative to “best care” in general practice, manipulation followed by exercise achieved a

moderate benefit at three months and a small benefit at 12 months; spinal manipulation

achieved a small to moderate benefit at three months and a small benefit at 12 months

• Licciardone et al (2003) OMT for chronic LBP. Spine. 28(13):1355–1362 – RCT (N=91), OMT, no treatment, sham (ROM, simulated OMT)

– OMT improvement pain, satisfaction & mental health compared no treatment

– No significant differences between OMT & sham

– But treatment from pre-doctoral students

• Chown et al (2008) A prospective study of patients with chronic back pain

randomised to group exercise, physiotherapy or osteopathy. Physiotherapy

94:21–28 – RCT (N=239), exercise, manipulative physiotherapy, OMT

– All 3 groups comparable Oswestry DI at 6 weeks; one to one therapies best satisfaction

• Licciardone et al (2010) OMT of back pain and related symptoms during

pregnancy: a RCT. Am J Obstet Gynecol 2010;202:43.e1-8. • During pregnancy back pain decreased and back-specific functioning deteriorated significantly

less in the usual obstetric care and OMT compared to usual obstetric care only and to usual

obstetric care & sham ultrasound

• Licciardone, J. C., et al. (2013). "Osteopathic manual treatment and

ultrasound therapy for chronic low back pain: a randomized controlled

trial." Ann Fam Med 11(2): 122-129. The OMT regimen met or exceeded the Cochrane Back Review Group criterion

for a medium effect size in relieving chronic low back pain. It was safe,

parsimonious, and well accepted by patients.

• Licciardone, J. C., et al. (2013). "Osteopathic manual treatment in patients with

diabetes mellitus and comorbid chronic low back pain: subgroup results from the

OSTEOPATHIC Trial." J Am Osteopath Assoc 113(6): 468-478.

• Licciardone, J. C., et al. (2013). "Outcomes of osteopathic manual treatment for

chronic low back pain according to baseline pain severity: Results from the

OSTEOPATHIC Trial." Man Ther.

Conclusion: OMT reduces low back pain

• Greater than expected from placebo effects (twice as great)

• Clinically important; comparable to NSAIDS, including COX-2 inhibitors, and may

last longer

• Persists at least through the first three months of treatment; and possibly as long

as the first year

Licciardone JC et al. Osteopathic manipulative treatment for low back pain:

a systematic review and meta-analysis of randomized controlled trials.

BMC Musculoskeletal Disorders 2005; 6: 43

Limited but growing evidence for effectiveness

of OMM/ OMT in other conditions

• Recent small RCT/ cohort studies demonstrating effectiveness of OMT in:

– Neck pain (Schwerla et al. 2008, Fryer et al. 2005)

– Primary dysmenorrhea (Schwerla et al. 2014)

– Pneumonia (Noll et al 1999, 2000)

– Irritable bowel syndrome (Hundscheid et al 2007)

– Constipation (Brugman et al. 2010)

– Otitis media (Degenhardt et al 2006, Mills et al 2003)

– Improve general immunity (Noll et al 2004)

– Peripheral arterial disease (Lombardini et al. 2008)

– Improved ambulation following surgery (Jarski et al 2000)

– Earlier recovery from surgery & quicker return toward

preoperative ventilation values (Sleszynski et al 1993)

Efficacy evidence for individual techniques

HVLA – Hypoalgesia (pain reduction) – strong

evidence

– Increase in spinal joint range of motion

– Sympathetic NS changes

– Improvement in proprioception and

motor control

Articulation / mobilization – Hypoalgesia (pain reduction)

– Sympathetic NS changes

Counterstrain – Small clinical studies

reporting effectiveness for:

– LBP

– Trapezius myalgia

– Pain & strength in hip

muscles

– Plantar fasciitis

– Achilles tendinitis

Muscle energy technique

– Reduction of LBP

– Increased range of spinal motion

– Increased muscle flexibility compared to

passive stretching

Resources

• Pedro http://www.pedro.org.au/

MSc Osteopathy 2013

• Oxford Centre for EBM http://www.cebm.net/

http://www.students4bestevidence.net

Resources

• CASP appraisal checklists

• Pubmed, Cinahl, Amed etc

• USA national guideline clearing house

– http://www.guideline.gov/index.aspx

• NICE

– http://www.nice.org.uk/

Resources

Thanks again for your attention!

E-mail: j.esteves@bso.ac.uk

Acknowledgements:

Steve Vogel DO

Vice Principal (Research) – British School of Osteopathy

Dr Gary Fryer PhD, BSc(Osteo), ND

Associate Professor, Discipline Leader – Osteopathic Studies

School of Biomedical & Health Sciences, Victoria University, Melbourne, Australia