Bør cervikalcolumna manipuleres? Henrik Wulff Christensen Nordic Ins<tute of Chiroprac<c and Clinical Biomechanics (NIKKB) Odense, Danmark

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1 Bør cervikalcolumna manipuleres? Henrik Wulff Christensen Nordic Ins<tute of Chiroprac<c and Clinical Biomechanics (NIKKB) Odense, Danmark

2 JA

3 Hvis der er indika.on Én (ud af mange) sikker og effek.v behandlingsmetode

4 Bivirkninger ved SMT 1. Godartede (benigne) normal reaktion! 2. Alvorlige - komplikationer

5 Benigne bivirkninger Den normale reaktion hos kiropraktor patienter Lokal ømhed (19%) Radikulært ubehag (4%) Træthed (4%) Hovedpine (4%) Svimmelhed (2.5%) Varme fornemmelse i huden (0.25%) Senstad et al., Scand J Prim Health Care (1996) - RETROSPEKTIVT

6 Benigne bivirkninger Den normale reaktion hos kiropraktor patienter Lokal ømhed (53%) Radikulært ubehag (10%) Træthed (11%) Hovedpine (12%) Svimmelhed (<5%) Varme fornemmelse i huden (<5%) Senstad et al., Spine (1997) PROSPEKTIVT

7 Benigne bivirkninger Den normale reaktion hos patienter med nakke smerter Nakke sm. eller ømhed (27.7%) [22.3%] Radikulært smerte/ubehag (6.4%) [5.8%] Træthed (12.1%) [7.9%] Hovedpine (15.6%) [15.8%] Svimmelhed (4.3%) [2.2%] * Opkastning (2.1%) [1.4%] * Sløret syn (2.8%) [0.7%] * Susen i ørene (3.5%) [2.2%] Forvirring/desorientering (1.4%) [2.5%] Hurwitz et al, JMPT (2004)

8 Alvorlige bivirkninger ved SMT 1. Lumbal diskus syndrom inkl. radikulopati og cauda equina syndrom 2. Cervical diskus syndrom inkl. radikulopati og myelopati 3. Forskellige post manipulative hændelser 4. Cerebrovasculære hændelser

9 Lumbal diskus syndrom Nerverodskompression Hyppighed: 1: (radikulært udfald) Cauda equina Hyppighed: 1:>

10 Cervical diskus syndrom Nerverodskompression Hyppighed: Ukendt/ Case reports Myelopati Hyppighed: Ukendt/ Case reports

11 Post manipula.ve hændelser Comorbiditet Antikoagulations behandling (hæmatom) Spondolytisk stenose (myelopati) Paget s sygdom (myelopati) Tumorer (myelopati)

12 Post manipula.ve hændelser Traumer Fractur (eks. costae, kompression?) Hæmatomer

13 Cervikal manipulativ behandling (CMB) : ca / år i USA yderst sparsom forskning!

14 Spændingshovedpine / smerter i nakken forekommer meget hyppigt nordmænd: 34% indenfor 1 år, 14% > 6 måneder Bovim G, Schrader H, Sand T Neck pain in the general population Spine 1994; 19:

15 RCT: effekt af CMB? Cochrane review 27 RCT, 1522 participants Cervical manipulation and mobilisation produced similar changes. Either may provide immediate- or short-term change; no long-term data are available. Optimal techniques and dose are unresolved. Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Manipulation or mobilisation for neck pain.gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Brønfort G, Hoving JL. Cochrane Database Syst Rev Jan 20; (1):CD Epub 2010 Jan 20.

16 Effekt af CMB? Best synthesis evidence 139 articles Our best evidence synthesis suggests that therapies involving manual therapy and exercise are more effective than usual care for patients with neck pain. Treatment of neck pain: noninvasive interventions: results of the Bone and Joint Decade Task Force on Neck Pain and Its Associated Disorders Spine (Phila Pa 1976) Feb 15;33(4 Suppl):S doi: /BRS. 0b013e b1d, Hurwitz et al,

17 The task force concluded: Manipulation as one of several firstline treatments for neck pain, whiplash, and related headaches (RCT + adverse effects) (Hurwitz Spine 2008) Decision analysis model examining drugs, exercise, mobilisation, and manipulation for neck pain incl benefits and harms and incorporating patient preferences NO CLEAR WINNER when the objective was to maximise quality adjusted life (Hurwitz Spine 2008)

18 »cervical manipulation arouses far more concern about safety than the use of lumbar manipulation«shekelle PG. What role for chiropractic in health care? N Engl J Med 1998;339:1074-5

19 »discourage the use of cervical manipulation. because of an unacceptably high risk/ benefit ratio«powell FC et al. A risk/benefit analysis of spinal manipulation therapy for relief of lumbar or cervical pain. Neurosurgery 1993;33(1):73-8

20 Frygt for vertebrobasilar arterie (VBA) hjerneblødning (stroke)

21 Hvor ofte sker VBA efter CMB? 1: : Vickers A, Zollman C. The manipulative therapies; osteopaty and chiropractic. BMJ 1999; 319: Carey PF: A report on the occurence of cerebral vascular accidents in chiropractic practice. J Can Chiropract Assoc 1993;37: Dvorak J et al.: How dangerous is manipulation of the cervical spine? Man Med 1985;2:1-4 Dabbs V et al.: A risk assessment of cervical manipulation vs. NSAIDs for the treatment of neck pain. J Manipulative Physiol Ther 1995;18: Terrett AGJ: Vascular accidents from cervical spine manipulation: Report on 107 cases. J Aust Chiro Assoc 1987;17:15-24 Haynes MJ: Stroke following cervical manipulation in Perth. Chiro J Aust 1994;24:42-46 Gutmann G: Verletzungen der Arteria vertebralis durch manuelle Therapie. Manuelle Medizin 1983;21:2-14 Dvorak J et al.: Frequency of complications of manipulation of the spine. A survey among the Swiss Medical Society of Manual Medicine. Eur Spine J 1993;2: Klougart N et al.: Safety in chiropractic practice, Part I; The occurrence of cerebrovascular accidents after manipulation to the neck in Denmark from J Manipulative Physiol Ther 1996;19: Hosek RS et al.: Cervical manipulation. JAMA 1981;245:

22 DK VBA i kiropraktorpraksis Patientforsikringen: 10 tilfælde Antagelse 550 kiropraktorer i DK patienter / år 7 behandlinger / pt 1/ /5 cervikale behandlinger

23 Patient karakteristik?

24 Age distribution

25 Tidsfaktor mellem SMT og CVA 69 % umiddelbart under SMT 3 % minutter efter SMT 9 % < 1 time efter SMT 8 % 1-6 timer efter SMT 5 % 7-24 timer efter SMT 6 % > 24 timer efter SMT Terrett, 1996

26 183 ptt Terrett AGJ. Vertebrobasilar Stroke following Manipulation. National Chiropractic Mutual Insurance Company, ptt Haldeman S et al. Risk factors and precipitating neck movements causing vertebrobasilar artery dissection after cervical trauma and spinal manipulation. Spine 1999; 24: ptt Smedegaard Andersen B & Thim HM CVAs and cervical manipulation a diploma study. Odense University 2001

27 # cases publiceret i 5-års intervaller

28 Cerebrovaskulære katastrofer efter SMT er meget sjældne: ca i litteraturen

29 Måske hyppigere? Lee KP, Carlini WG, McCormick GF, Albers GW. Neurologic complications following chiropractic manipulation: a survey of California neurologists. Neurology 1995; 45: Robertson JT. Authors rebuttal to»neck manipulation as a cause of stroke«. Stroke 1982; 13: Rivett DA, Milburn PD. Complications arising from spinal manipulative therapy in New Zealand. Physiotherapy 1997; 83:

30 Klinik Risikopa.enten? alder køn diabetes/rygestatus/hormonel behandling m.m. symptomer forandringer i col. cerv. vaskulære forandringer (e.g. Ehlors- Danlos) comorbiditet

31 Rubinstein, Thesis 2008 Sidney

32 Cervical arterie dissec.on Gene.sk predisposi.on a1 (ingen associa.on), bindevævssygdomme (mulig associa.on), gene muta.oner (ingen associa.on), homocystein (stærk associa.on), karabnormaliteter (stærk associa.on), migræne (stærk associa.on) METODEPROBLEMER; selek.on bias, lille studie, manglende mul.variat analyse, mangelen blinding af undersøger, mulig confounder Rubinstein 2008

33 Cervical arterie dissec.on Miljøfaktorer infek.oner (svag associa.on), p- piller (posi.v associa.on) METODEPROBLEMER: selek.onsbias, manglende blinding, manglende stra.ficering. Rubinstein 2008

34 Cervical arterie dissec.on Traume manipula.on (stærk associa.on) METODEPROBLEMER: små studier (n=7), selek.ons og informa.ons bias. Rubinstein 2008

35 Cervical arterie dissec.on Risikofaktorer for arteriosklerose vaskulære risikofaktorer (hypertension, DM, rygning, p- piller, kolesterol) nega.v associa.on sammenlignet med andre strokes - alder < 45 år højere frekvens METODEPROBLEMER: ingen rapporteret. Rubinstein 2008

36 Predictors of adverse events Prospek.vt, mul.center kohorte studie 579 pa.enter 60 uabængige variable undersøgt 4 faktorer var prædik.ve for adverse event i.lfælde af kiroprak.sk behandling for nakkesmerter en af disse beskycende effekt Rubinstein 2008

37 Predictors of adverse events Rapporteret brug af rota.onsteknik ved behandling i nakken Erhvervsstatus (fuld.d, del.d, arbejdsløs >< sygemeldt/understøcelse) Langvarige nakkesmerter indenfor det sidste år (>60 dg) Beskycende effekt: besøg hos e.l. inden besøg hos kiropraktor Rubinstein 2008

38 Klinik Manipula.onen behandlingsstyrken behandlingsfrekvensen behandlingsniveauet selve teknikken

39 Anbefalinger ved SMT i cervical kolumna Størstedelen af.lfælde drejer sig om skader på AV i øvre del af nakken. Rota.on af col. cerv. i særlig grad kompromicerer AV i den øvre del af nakken. Med rimelighed kan antages, at især rota.onsbehandling har været anvendt på de skadeslidte pa.enter.

40 Symptomer ved muligt CVI Svimmelhed Bevistløshed Dobbeltsyn Dysarthria Dysphagia Ataxi Opkastninger Følelsesløshed Nystagmus

41 ... er manipulationsbehandling farlig?

42 Er behandling av cervikalcolumna farlig Henrik Wulff Christensen Nordic Ins<tute of Chiroprac<c and Clinical Biomechanics Odense, Danmark

43 NEJ

44

45 Vertebrobasilar Artery (VBA) Stroke and Chiropractic Care One concern about manipulation is the risk of stroke Multiple case reports of VBA dissection and stroke lowest level of evidence Other activitites like rotation and extension af the neck, yoga, looking up and hair washing at a salon have been reported as cases J. David Cassidy, DC, PhD, DrMedSc

46 Prævalens, incidens, prognose, risiko Cohort Case- control Designed studies Cross- sec<onal Case- series Case- reports Clinical observa<on

47 Learning Objectives Consider epidemiology of vertebral artery dissection and subsequent stroke. Understand strengths and weakness of the evidence on this issue. Consider causal mechanisms for stroke in younger persons seeking chiropractic care. 47

48 Presentation Stroke and Chiropractic Past Studies Study Methods Study Results Discussion 48

49 Cervical Artery Dissections Internal Carotid Vertebral 49

50 Cervical Artery Dissections Arise from intimal tear Possible risk factors: genetic (connective tissue disorder), migraine, minor trauma, spontaneous (idiopathic) Prognosis depends on severity (stenosis, collateral circulation and thromboembolic complications) Most strokes due to dissection are thromboembolic Most recover (< 5% deaths) Annual incidence of dissection-related strokes (from Olmstead County, MN: Lee et al., Neurology 2006: 67: ): Carotid: 1.72 per 100,000 per year in population (95% CI: ) Vertebral: 0.97 per 100,000 per year in population (95% CI: ) 80% presented with head or neck pain 50

51 Chiropractic Stroke? Vertebral Dissection VBA Stroke C1-2 Rotation Over 80% of patients with vertebral artery dissection present with neck and/or headache (Lee et al., Neurology, 2006). 51

52 Chiropractic Stroke? 52

53 Chiropractic Stroke? 53

54 Past Studies Multiple case reports and opinion papers. Occurs in previously healthy young people Only 3 analytic (i.e., controlled) studies: Rothwell et al., Stroke 2001 (Ontario) Smith et al., Neurology 2003 (California) Cassidy et al., Spine 2008 (Ontario) 54

55 Past Case-Control Study Past Chiropractic Service within one week? yes no Time 582 stroke cases Ontario (pop.~11 M) yes no 2,328 different control subjects < 45 years old: OR=5.03 (95% CI= ) * Rothwell et al., Stroke 2001

56 Past Case-Control Study Past Chiropractic Service within 30 Days? yes no yes no Time 26 CAD 51 VAD N=100 Other Strokes N=100 UCSF & Stanford Stroke Registries N=1,107 < 60 years old OR not significant for all and CAD OR= 6.6 (95% CI=1.4-30) for VAD Smith et al., Neurology

57 Presentation Stroke and Chiropractic Past Studies Study Methods Study Results Discussion 57

58 Study Population Ontario population (pop.~12 million) Excluding institutionalized, Military Universal health care databases: 94% of population covered CIHI hospitalizations capture VBA stroke OHIP ambulatory care captures chiropractic and physician visits (exposures)

59 Cases Methods All incident VBA stroke cases hospitalized over 9 years in Ontario ICD and (occlusion and stenosis of vertebral and basilar artery) No previous hospital admission for stroke Controls (4 per case) Matched on sex and age No previous hospital admission for stroke

60 Study Exposures 1. Chiropractic (DC) Diagnostic billing codes used to identify services Excludes radiographic services Identified headache and neck pain services 2. General Practitioners (GP) Diagnostic billing codes used to identify services Excludes services without individual patient care Identified headache and neck pain services

61 Designs 1. Matched Pair Case Control Control is different person matched on age and sex to case on index date 2. Matched Pair Case Crossover Control is same person matched to themselves at previous times. Better control of confounding factors.

62 Case-Control Design Past DC or GP Service within x days? yes no Time 818 stroke cases Ontario (pop.~12 M) yes no 3,164 different control subjects Cassidy et al, Spine 2008 Stratified by < 45 years and >= 45 years old

63 Case-Crossover Design Past DC or GP Service within x days? yes no Time 818 stroke cases Ontario (pop.~12 M) yes no Multiple past control times Stratified by < 45 years and >= 45 years old

64 Case-Crossover Design week 2 weeks week 2 week washout 0-7 days 1 year time prior to stroke 0 Stroke (index) date: Exposure window: Washout period: Control periods:

65 Presentation Stroke and Chiropractic Past Studies Study Methods Study Results Discussion

66 Results VBA 818 VBA strokes from > 109 million person-years at risk 36.7% female Mean age 63; Median age case < 45 years

67 Comorbid Conditions Variable* Cases (n=818) Controls (n=3,164) Hypertension 276 (33.7%) 738 (23.3%) Heart Disease 275 (33.6%) 506 (16.0%) Diabetes 155 (19.0%) 247 (7.8%) High Cholesterol 62 (7.6%) 200 (6.3%) At least one risk factor 515 (63.0%) 1,294 (40.9%) * Ambulatory diagnoses from data during the one-year period preceding the index date

68 Case Control: DC Exposure window Odds Ratio (95% CI) Case Control Age < 45 years Age 45 years Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI 0-1 days 1.1 ( ) ( ) * 0.6 ( ) days 0.9 ( ) ( ) ( ) days 1.00 ( ) ( ) ( ) days 1.2 ( ) ( ) ( ) days 1.1 ( ) ( ) ( ) * Unable to estimate

69 Case Control: GP Exposure window Odds Ratio (95% CI) Case Control Age < 45 years Age 45 years Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI 1-1 days 7.2 ( ) ( ) ( ) days 3.6 ( ) ( ) ( ) days 3.3 ( ) ( ) ( ) days 3.1 ( ) ( ) ( ) days 2.8 ( ) ( ) ( )

70 Case Crossover: DC Exposure window Case Crossover Age < 45 years Age 45 years Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI 0-1 days 1.8 ( ) ( ) * 1.1 ( ) days 1.1 ( ) ( ) * 0.6 ( ) days 0.8 ( ) ( ) * 0.3 ( ) * 0-14 days 1.5 ( ) ( ) * 1.0 ( ) days 1.3 ( ) ( ) ( ) * Unable to estimate

71 Case Crossover: GP Exposure window Case Crossover Age < 45 years Age 45 years Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI 1-1 days 4.4 ( ) ( ) ( ) days 2.9 ( ) ( ) ( ) days 2.4 ( ) ( ) ( ) days 2.4 ( ) ( ) ( ) days 2.4 ( ) ( ) ( )

72 Number of Services All cases Age < 45 years Age 45 years Services month before index date Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI Odds Ratio (95% CI) Bootstrap 95% CI Chiropractic services 1.1 ( ) ( ) ( ) General practitioner services 1.5 ( ) ( ) ( ) Headache or cervical chiropractic services 1.2 ( ) ( ) * 1.0 ( ) Headache or cervical general practitioner services 4.0 ( ) ( ) ( ) * Unable to estimate

73 Presentation Stroke and Chiropractic Past Studies Study Methods Study Results Discussion

74 Discussion VBA strokes in persons under age 45 years over 9 years in Ontario 2. Risks are same for DC and GP 3. Risks are greater for neck/head pain related visits to GP and DC

75 Causal Pathways? 1. Chiropractic causes dissection Vertebrobasilar Dissection Stroke Neck Pain Headache Chiropractic Manipulation

76 Causal Pathways? 2a. Chiropractic causes thrombus Dissection Thrombus Stroke Neck Pain Headache Chiropractic Manipulation

77 Causal Pathways? 2b. DC or GP causes thrombus Dissection Thrombus Stroke Neck Pain Headache DC/GP visit

78 Causal Pathways? 3. DC or GP visit not causal Dissection Thrombus Stroke Neck Pain Headache DC/GP visit Protopathic Bias

79 Strengths - Limitations 1. Large source population (more than 109 million person-years) 2. Accurate and independent measures of GP and DC visits (exposures) 3. Selection bias controlled by design 4. Confounding controlled by design 5. Misclassification of stroke diagnoses

80 Take Home Messages 1. VBA stroke is rare. 2. Risk is the same for DC and GP care. 3. Dissection presenting as neck pain and/or headache likely explains these associations. 4. More studies needed.

81 ... er det farligt at komme på hospital?

82 Review af journaler fra 51 NY hospitaler i ,7 %»disabling iatrogenic injuries«13,6% af disse fatale Brennan TA et al. Incidence of adverse events and negligence in hospitalized patients Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324: Leape LL et al. The nature of adverse events in hospitalized patients Results of the Harvard Medical Practice Study II. N Engl J Med 1991;324:

83 Generel anæstesi mortalitet 1-4 / Fedtsugning 15 døde ved operationer CABG 3,7 % - 11,0 % 3,4 % - 5,7 % ( ptt) Hofte alloplastik 4,0 % - 20,9% 1,1 % - 1,9 % ( ptt) TUR-P 1,1 % ( ptt) Hemorrhoidectomy 11 % (+70 årige)

84 Sammenlignet med mange andre smertelindrende procedurer (kirurgi) synes SMT ikke at være specielt farligt

85 Den udbredte frygt blandt sundhedspersonale for SMT er måske mere et fagpolitisk holdning end et egentligt klinisk problem?

86 More Information? Web sites: Acknowledgements: David Cassidy for providing most of the slides

87 Internal caro.d artery strains during HVLA manipula.on of the neck SMT been postulated to damage internal structure at the treatment site Licle informa.on Examined (n=12) sonomicrometry strains on caro.d artery during ROM and SMT Concluded: Maximal ICA strains imparted by cervical SMT were well within the normal ROM (thus does not seem to be a factor of ICA injuries) Herzog et al, JMPT, 2012