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RESEARCH COMMENTARY
by
Keith Wobeser, PT, OCS, COMT
MAPS Faculty, Fellow in Training, MAPS Orthopedic Manual Therapy Fellowship 

Chris R Showalter, PT, OCS, COMT, FAAOMPT 
Fellowship Program Director


Mobilization vs Manipulation for Neck and Back Pain — Is There a Difference? It Depends on
How You Study Them.
 
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Cervical Spine Thrust Manipulation: Minimize the risks with Cervical Artery Dysfunction Assessment

October 15, 2013

RESEARCH COMMENTARY

Chris Showalter PT, OCS, COMT, FAAOMPT

MAPS Clinical Director

Cervical Spine Thrust Manipulation:

Minimize the risks with Cervical Artery Dysfunction Assessment

Our last Research Commentary (Sept 17, 2013), discussed the risks associated with cervical spine thrust manipulation.  Incidence rates of complications following thrust vary enormously from 1 in 50,000 to 6 in 10 Million. These figures result in little consensus.

The difficulty is that these incidence rate calculations are primarily based upon “reported� events. Therefore, the TRUE incidence of adverse events may be masked and confounded by potentially low, to almost non-existent, rates of practitioners voluntarily reporting, in writing, that they have actually “harmed a patient with their thrust intervention�.

We have previously discussed the life-changing and potentially career-threatening consequences of such an unsolicited admission of guilt, albeit well intentioned.

The issue of underreporting of adverse events cannot be emphasized strongly enough. Therapists could publish case reports of adverse events in the literature and accept the consequences, which may be significant. A different, and arguably superior, reporting option may be the establishment of a centralized, online, anonymous portal for reporting adverse events. The anonymity would likely lessen therapist’s reservations to report events. Until this occurs, we must appreciate that underreporting may be commonplace.  We just don’t know.

One of the papers referred to in the last commentary (Puentedura 2012) was particularly enlightening and reviewed 134 case reports of adverse events (in 93 articles) between 1950 and 2010.   The authors concluded that:

Arterial dissection was the most common adverse event representing 37.3% of the reported cases.

  1. Seven (5.2%) of the 134 reported cases of adverse events resulted in death, 5 by arterial dissection, 2 by CVA (Stroke).
  2. Four of the deaths (57.1%) were determined to be preventable.
  3. 19.4% of cervical thrusts were performed for inappropriate conditions (conditions unlikely to benefit from thrust) and thus, these patients were placed at risk unnecessarily, because they were unlikely to benefit from the technique. 
  4. 10.5% of the 7 reported deaths in this paper were determined to be unpreventable, suggesting the inherent risk of performing manipulations, even after a thorough examination and proper clinical reasoning.
  5. 44.8% of adverse events were determined by the authors to be potentially preventable, when clinicians ruled out all contraindications and red flags.

Puentedura 2012 and colleagues concluded that 44.8% of the 134 adverse events were preventable when clinicians:

1) ruled out contraindications and red flags

2) performed a thorough examination, and

3) used sound clinical reasoning.         

What Else Can Be Done to Protect Your Patients (and Yourself)?

What the Puentadura paper did not specifically address was the impact of evaluating patients prior to manipulation for what is now known as Cervical Arterial Dysfunction (CAD).

The history of CAD evaluation goes back many years. CAD has previously been known as Vertebro-Basilar Insufficiency (VBI).  Geoff Maitland first advocated screening for VBI in the Subjective Examination (S/E) by specifically questioning the patient about symptoms, including dizziness, and particularly symptoms in response to cervical movements. (Maitland 1979).  Maitland advocated for evaluation of VBI in the Physical Examination (P/E) and finally, specific testing of symptom response to sustained rotations and sustained extension.  Emphasis was given to the clinical reasoning underlying the decision to manipulate.

It is worth noting that MAPS has ALWAYS taught and advocated the most current protocols, guidelines and procedures AND UNDERLYING CLINICAL REASONING concerning VBI and CAD. This has been true since MAPS began offering educational courses for US Physical Therapists in 1985. Our intention has always been to inform clinicians regarding potential risk in any procedures taught and practiced and to ensure maximum patient safety.  In fact, MAPS requires that all participants must be evaluated for VBI (CAD) immediately prior to laboratory practice in any of our courses where cervical manipulation will be taught or practiced.

BRIEF History of VBI, CAD Protocols and Guidelines

--1988…The Australian Physiotherapy Association (APA) first developed a “Protocol for Pre-manipulative Testing of the Cervical Spine� (APA 1988). Focused S/E, appropriate P/E and a number of tests were recommended including: sustained rotations, sustained extension, and sustained rotations with extension. Clinical reasoning was emphasized.

--2000…This protocol approach was changed to recommended clinical guidelines when revised as “Clinical Guidelines for Pre-Manipulative Procedures for the Cervical Spine� (APA 2000).

--2006… “Clinical Guidelines for Assessing Vertebrobasilar Insufficiency in the Management of Cervical Spine Disordersâ€? (APA 2006). This final revised guideline advocated the importance of a focused S/E, an appropriate P/E, and minimum specific testing of sustained rotations held for 10 seconds each side with a 10 second intervening rest period to ensure there were no latent symptoms. Further testing may include extension, extension with rotation, simulated thrust position (if manipulation is to be employed) and any quick movements of the head that the patient reports have induced VBI symptoms previously. Clinical reasoning is paramount in the decision regarding the type of intervention to be given to the patient. 

What is The CAD Standard Today? 

In October 2012 the International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) released the “International Framework for Examination of the Cervical Region for potential of Cervical Arterial Dysfunction prior to Orthopaedic Manual Therapy Intervention.â€?  This framework is a consensus document and presents a clinical reasoning framework for best practice.  It was developed by an international collaboration of the IFOMPT Standards Committee and international subject experts.

Legal Ramifications of the CAD Standard:   According to MAPS legal counsel, Peter McGreevy Esq. this international consensus document has significant medico-legal ramifications for all US Physical Therapists. IFOMPT is a subgroup of the World Confederation of Physical Therapists (WCPT) and the American Physical Therapy Association (APTA) is a member organization of WCPT. Thus, the framework is considered to be the de facto world standard and US Physical Therapists are expected to be aware of the framework and practice accordingly.

Framework of the IFOMPT CAD Document.  Below is a brief synopsis of the framework in this commentary, however, I highly recommend you read the document in its entirety. The document can be found at: http://www.ifompt.com/ReportsDocuments.html

Below is a quote from the framework document:

“Within the cervical spine, events and presentations of CAD are rare, but are an important consideration as part of an OMT assessment.  Arterial dissection (and other vascular) presentations are fairly recognisable if the appropriate questions are asked during the patient history, if interpretation of elicited data enables recognition of this potential, and if the physical examination can be adapted to explore any potential vasculogenic hypothesis further.  The framework is therefore reflective of best practice and aims to place risk in an appropriate context that is informed by the evidence. In this context, the framework considers ischaemic and non-ischaemic presentations to identify risk, prior to overt symptoms in a patient presenting for cervical management.â€?

“An important underlying principle of the framework is that physical therapists cannot rely on the results of only one test to draw conclusions, and therefore development of an understanding of the patient’s presentation following an informed, planned and individualised assessment is essential.  There are multiple sources of information available from the process of patient assessment to improve the confidence of estimating the probability of CAD.  Data available to inform clinical reasoning will improve and change with ongoing research.  This framework therefore encourages physical therapists to critically read the current literature to enable support for their clinical decisions, rather than provide specific data prescriptive guidance, as the evidence base for this is not available.â€?

“The framework is intended to be informative and not prescriptive, and aims to enhance the physical therapist’s clinical reasoning as part of the process of patient assessment and treatment.  The framework is intended as simple and flexible in its ability to be applied to an individual patient to facilitate patient centered-practice.â€?

What does the framework advocate?  Clinical Reasoning is the overwhelming theme as an ongoing process that involves multiple factors.  These factors include a patient centered evaluation in the S/E, the P/E, and the subsequent Orthopedic Manual Therapist (OMT) Intervention, and its outcome.  Clinical reasoning should be an ongoing process throughout the entire assessment and treatment process.  Particular effort should be made to perform a “Risk versus Benefitâ€? analysis, and act accordingly.

During the Subjective Exam (S/E)... The clinician is responsible for questioning for and recognizing the Contraindications and Precautions to various OMT interventions, and understanding the risk factors and presentations of CAD and Upper Cervical Instability.   Significant emphasis is placed on recognizing and endeavoring to differentially diagnose symptoms of musculoskeletal origin from other more serious pathologies originating from the Internal Carotid and Vertebrobasilar Arteries, and Upper Cervical Instabilities.

During the Physical Exam (P/E)...  Hypertension assessment may be required, and as necessary: craniovertebral ligamentous testing, neurological examination, palpation of the carotid artery and positional testing.  The provocative positional testing approaches recommended are:

a) Sustained end-range rotation as this has been advocated as the most provocative and reliable test (Mitchell 2004).   

b) Sustained pre-manipulative test position is also advocated (Rivett 2006).

c) It is noted that the predictive ability of either of these tests to identify individuals at risk is lacking.

 

Patient’s Informed Consent.  Informed consent is discussed in great detail in the framework document.  Whatever the form of consent, it should be given voluntarily and without undue influence from the therapist and should be recorded in a standardized manner in the patient’s clinical chart.  Once the patient has given consent they can withdraw consent at any time during treatment.  Informed consent can be of various types, including:

a) Express Consent.  Consent is given explicitly in writing or verbally and this form of consent is recommended when initially seeking informed consent for a treatment intervention e.g. cervical manipulation…offers the fullest legal protection

b) Implied Consent.  Following discussion with the therapist the patient lies down on the treatment table signaling they are ready to begin treatment…legally less reliable

c) Tacit Consent.  The patient fails to disagree with the therapist…legally tacit consent is less reliable.

d) Embodied Consent.   Assessment of the patient’s body language for consent to treatment, if the therapist observes body language that may indicate the patient is uncomfortable with proceeding, the therapist should stop the procedure immediately and ask the patient if it is acceptable to continue (ergo, Express Consent).

  • Safe Orthopedic Manual Therapy (OMT) Practice--as per IFOMPT.  The consensus IFOMPT document recommends “good practiceâ€? during the selection and application of techniques, including: 

1)  Use of minimal force, i.e. low amplitude, short lever techniques

2)  Patient safety and comfort form the basis for technique selection

3)  Cervical Manipulation techniques should be comfortable to the patient

4)  Cervical Manipulation techniques should not be performed at end of range of cervical movement, particularly extension and rotation

5)  Using flexibility in choice of patient position to enhance patient feedback

6)  Applying and assessing the response to the pre-manipulative test position   prior to performing the manipulation

7)  Continuous monitoring of all cervical spine movements including manipulation

8)  The therapist must recognize if they lack the skills to safely perform manipulation, referral to a suitably trained colleague may be appropriate

9)  Recognizing that in lieu of cervical manipulation, approaches such as cervical mobilization, and thoracic manipulation may have beneficial effects in the initial treatment sessions with a low level of risk

10)  Avoiding repeated manipulations in the neck

11)  Continuously monitor the patient for any adverse effects

12)  Be prepared to administer Cardiopulmonary Resuscitation (CPR) and immediately contact authorities should an emergency occur

  • The consensus IFOMPT document concludes with recommendations regarding:

1) The teaching of OMT for the cervical region

         --A framework for those teaching cervical assessment and treatment

        --Recommended qualifications for Instructors

2) Proposed response to the media (key message to communicate)    

3) A Comprehensive reference list

Practitioners Should Be Aware of the Risks & Act Accordingly

Manipulation can be a very safe and effective manual therapy treatment.  Despite the large variation in evidence regarding potential adverse events from manipulation, practitioners who perform manipulation need to be aware of the risks, and act accordingly in the best interest of the patient. 

  • Estimated incidence of injury ranges from 1 in 50,000 to 6 in 10 Million (0.00006%-0.2%), showing enormous variation and thus, resulting in little consensus.
  • Underreporting of adverse events may be commonplace.  We just don’t know.
  • The most frequently reported severe injuries, between 31.0% (Haldeman 1999) and 37.3% (Puentedura 2012) involved arterial dissection.
  • Although the risk of an adverse event, based on reported events, appears to be quite small, if it does occur, the risk of death is between 18% (Di Fabio 1999) and 5.2% (Puentedura 2012).
  • 44.8% of adverse events are potentially preventable, by ruling out contraindications and red flags and using sound clinical reasoning (Puentedura 2012).
  • 10.5% of the deaths in an adverse event were unpreventable, suggesting inherent risk even after thorough examination and the use of proper clinical reasoning (Puentedura 2012).

How To Minimize the Risk of An Adverse Event for Your Patients?

1) Recognize that the risk is real, despite lack of consensus on incidence rates.

2) Consider all the evidence and remember:  “Adverse events may be rare, but when they do occur, they can be catastrophic and potentially deadly.â€?

3) Use every available clinical tool at your disposal to ensure your patient’s safety:

  • Rule out ALL Contraindications and Red Flags.
  • Perform an accurate and detailed examination.
  • Utilize the VBI-CAD assessment detailed in the IFOMPT consensus document.
  • Discriminate wisely in the use of manipulations such that you:

    --Use thrust on clinical conditions likely to respond to thrust.

    --If using thrust, use techniques considered to carry less risk (e.g., short lever, low amplitude) whenever possible.

4) If there is ANY doubt regarding the use of thrust, consider using a trial of non-thrust, localized graded MOBILIZATION.

  • Perform a detailed, patient-centered assessment including CAD components
  • Begin treatment short of resistance.
  • Assess the effect your technique has upon the patient’s symptoms.
  • Based upon clinical reasoning, mobilize into resistance as needed.  You can add force and /or velocity (thrust) to your techniques when you know the effect more gentle techniques have had on your patient.

Future Directions—A Call to Action

Clinicians, Researchers and Professional Organizations should recognize there are risks associated with cervical thrust, and we urge PT professionals to consider supporting the following initiatives:

1)  Develop an accepted standardized methodology for analyzing risk

2)  Develop a methodology or mechanism for reporting adverse events, anonymously if Necessary.

3) Use standardized terminology

4) Remember “Above all, do no harm� from the Hippocratic Oath

Cheers and Enjoy,

Chris R. Showalter PT, OCS, COMT, FAAOMPT 

© 2013 Chris R. Showalter and Maitland Australian Physiotherapy Seminars

Not to be reproduced, copied or retransmitted in any manner without author’s express written permission

Directing others to the MAPS website (www.ozpt.com) is permissible.

Where to find the Articles  

1) http://www.ingentaconnect.com/content/maney/jmt/2012/00000020/00000002/art00003?token=004e17b35f881ac383a4b3b25702a7b597a403859354063542a726e2d58464340592f3f3b57e85

Safety of cervical spine manipulation: are adverse events preventable and are manipulations being performed appropriately? A review of 134 case reports

Puentedura, EJ; March, J; Anders, J; Perez, A; Landers, M; Wallmann, H; Cleland, J. J of Manual and Manip Therapy 2012;20(2):66-74

2) Examination of the Cervical Spine

Maitland GD, Australian Journal of Phys. 1979;25(2):49-57

3) Protocol for Pre-manipulative Testing of the Cervical Spine

Australian Physiotherapy Association 1988

4) Clinical Guidelines for Pre-manipulative Procedures for the Cervical Spine

Australian Physiotherapy Association 2000

5) Clinical Guidelines for Assessing Vertebrobasilar Insufficiency in the Management of Cervical Spine Disorders

Rivett D, Shirley D, Magarey M. et al; Australian Physiotherapy Association 2006

6) International Framework for Examination of the Cervical Region for potential of Cervical Arterial Dysfunction prior to Orthopaedic Manual Therapy Intervention

International Federation of Orthopaedic Manipulative Physical Therapists

7) Is cervical rotation, as used in the standard vertebrobasilar insufficiency test, associated with measurable change in intracranial vertebral artery blood flow?

Mitchell J, Keene D, Dyson C et al, Manual Therapy 2004;9(4):220-227

8) http://www.ncbi.nlm.nih.gov/pubmed/10222530

Risk factors and precipitating neck movements causing vertebrobasilar artery dissection after cervical trauma and spinal manipulation.

Haldeman S, Kohlbeck FJ, McGregor M. Spine (Phila Pa 1976). 1999 Apr 15;24(8):785-94

9) http://www.ncbi.nlm.nih.gov/pubmed/9920191

Manipulation of the cervical spine: risks and benefits.

Di Fabio RP. Phys Ther. 1999 Jan;79(1):50-65

 


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