Safety and Patient Screening

CHAPTER 4

Safety and Patient
Screening

Introduction

Manipulation is an alternative form of intervention to treat musculoskeletal conditions. It is considered relatively safe and effective when administered skilfully and appropriately. However, as with all interventions, there are known risks and contraindications to manipulation as well. Although the frequency of severe adverse events is very low (Coulter, 1998), certain conditions require special caution to be exercised while performing manipulative procedures. These include, for example, vascular disease, osteoporosis, disc herniation, nerve injury and vertebral artery syndrome (Ernst, 2007).

Over the past decades, protocols or clinical guidelines have been developed to assist the practitioner in identifying patients at risk (Rivett, Thomas and Bolton, 2005). The protocols include absolute contraindications and red flag symptoms in which manipulation should never be performed. In addition, there are relative contraindications where the intervention or procedure is modified so that the recipient is not at an unwarranted risk (Puentedura et al., 2012).

Prevention of complications can be further facilitated if sound clinical judgement is practised, adequate skill is exercised and quality care is provided. It is also of significant importance that when onset of a complication is associated with a manipulative procedure, the intervention should not be repeated (Refshauge et al., 2002).

Elements for determining the appropriateness of a manipulation technique include detailed history-taking, thorough physical examination and adequate evaluation of the recipient’s pre-existing and presenting condition (Rivett et al., 2005). Several provocative testing procedures are performed to determine the safety and efficacy of a manipulation technique. These include laboratory tests, skeletal imaging, orthopaedic and neurological examinations, as well as observational and tactile assessments. Good clinical management involves timely re-evaluation of the patient’s progress during the course of the treatment, effective practitioner–patient communication, supportive and adjunctive measures, rehabilitative and preventive exercises, and patient education and counselling (World Health Organization, 2005).

The existing risk assessment protocols and guidelines, however, have been subjected to critical reviews in recent years (Rivett et al., 2005). The adequacy of the pre-manipulative provocative tests is questioned (Refshauge, 2001), because a number of studies have demonstrated a high rate of both false positive and false negative results (Bolton, Stick and Lord, 1989; Cote et al., 1995; Westaway, Stratford and Symons, 2003). It has been identified that this inconsistency in test results is largely due to the lack of accurate and reliable screening tools (Puentedura et al., 2012). As a result, the goal to establish adequate guidelines for standards of practice and develop acceptable preventive strategies is yet not achieved.

The aim of this chapter is to review complications of and contraindications to manipulation that have been suggested so far and illustrate various clinical conditions that require treatment modification.

Complications of Spinal Manipulation

Spinal manipulation has been a safe and effective means of treating a variety of biomechanical problems of the spine. As with all conventional treatments, manipulation also has the potential to cause complications, but the risk of serious adverse events following a manipulative procedure is so far unknown (Di Fabio, 1999).

Causes of Complications and Adverse Events

•Lack of knowledge

•Misdiagnosis

•Insufficient examination

•Poor clinical judgement

•Poor interprofessional cooperation

•Inappropriate technique application

•Lack of rational attitude and technique

•Unnecessary or excessive use of manipulation

•Cervical manipulation

•Presence of a herniated nucleus pulposus

•Presence of arteriosclerotic disease

•Presence of coagulation dyscrasias

Sources: Shekelle et al. (1991); Henderson (1992); Refshauge et al. (2002)

Chiropractors tend to downplay the risks of life-threatening complications due to manipulation (Killinger, 2004) and often attribute those to poor clinical judgement, inadequate skill or inappropriate use of techniques (Haneline and Triano, 2005). However, several recent systematic reviews have highlighted a range of serious adverse events following cervical spine manipulation and suggest that serious complications do exist (Ernst, 2007; Gouveia, Castanho and Ferreira, 2009; Puentedura et al., 2012). Nevertheless, many of these concerns have been derived from epidemiologic inference, and the reports of serious complications have primarily been based on case reports and prospective or retrospective studies. Furthermore, based on the estimates done in the published literature, it has repeatedly been suggested that the frequency of these incidences is rare (Coulter, 1998; Haldeman et al., 2001; Gouveia et al., 2009). As a result, the cause-and-effect relationship between manipulation and such adverse events is yet not established.

Table 4.1 Adverse consequences of spinal manipulation
Severity	Complications	Frequency	Reference
Mild to moderate	•Localised discomfort •Weakness •Increased pain •Radiation of pain •Paraesthesia •Headaches •Visual disturbance •Stiffness •Fatigue •Vertigo •Loss of consciousness	About 33–61%	Gouveia et al. (2009)
Serious	•Stroke •Vertebral artery dissection •Internal carotid artery dissection •Myelopathy •Pathological fractures •Dural tear •Costochondral separation •Rib fracture •Disc herniation •Cauda equina syndrome •Vascular accident •Death	Extremely rare	Ernst (2007); World Health Organization (2005)

In general, complications following a spinal manipulation range from non-serious side effects, such as localised discomfort, fatigue or headache, to serious adverse events, such as stroke, vascular accidents or death (Refshauge et al., 2002). Minor side effects from a manipulative procedure are relatively common and may occur in up to 55% of patients (Senstad, Leboeuf-Yde and Borchgrevink, 1997). However, most of these adverse issues are self-limiting and often resolve within 24–48 hours (Cagnie et al., 2004). Conversely, serious complications of manipulation are considered to be extremely rare (Triano, 2001). The precise incidence of such adverse events is yet not known, but estimates of risks have been reported to vary widely between studies (see Tables 4.2 and 4.3).

The most serious adverse event frequently reported in these studies is vertebral artery dissection, which has been thought to result from over-stretching of the artery during rotational manipulation (Nadgir et al., 2003). Ernst (2007) suggests that this seems to occur at the level of the atlantoaxial joint and involve the vertebrobasilar system, particularly the distal loop of the vertebral artery. The incidence of vertebral artery dissection, however, is considered to be rare. The calculated rate of incidence is 1 per 5.85 million cervical manipulations (Haldeman et al., 2002).

Table 4.2 Rate of serious adverse events due to spinal manipulation
Rate of complications	Manipulated region of the spine	Authors
1 per 1.3 million	Cervical spine	Klougart, Leboeuf-Yde and Rasmussen (1996)
1 per 8.06 million	Cervical spine	Haldeman et al. (2001)
1 per 50,000	Cervical spine	Magarey et al. (2004)
1.46 per 10 million	Not mentioned (represented the whole spine)	Gouveia et al. (2009)
6.39 per 10 million	Cervical spine	Coulter (1998)
1 per 100 million	Lumbar spine	Coulter (1998)

Table 4.3 Nature of serious complications following spinal manipulation
Nature of complication	Frequency of incidence	Reference
Vertebral artery dissection	1 per 5.85 million cervical manipulations	Haldeman et al. (2002)
Cerebrovascular accident	1 per 0.9 million upper cervical spine manipulation	Klougart et al. (1996)
Cerebrovascular accident	1 per 100,000 chiropractic office visits	Rothwell, Bondy and Williams (2001)
Neurovascular compromise	1 per 50,000 to 1 per 5 million manipulations	Rivett and Milburn (1996)
Stroke	5 per 100,000 manipulations	Gouveia et al. (2009)
Stroke	1 per 163,000 cervical spine manipulations	Rivett and Reid (1998)
Stroke	1 per 200,000 cervical spine manipulations	Haynes (1994)
Death	2.68 per 10 million manipulations	Coulter et al. (1996); Gouveia et al. (2009)

To put things in perspective, some authors have compared the frequency of serious incidences for manipulation with other forms of conventional therapy for the same conditions. In comparison, Coulter (1998) suggests that the use of spinal manipulation is far safer than conservative treatments: non-steroidal anti-inflammatory drugs (NSAIDs) are associated with 3.2 complications per 1000 patients and cervical spine surgery has 15.6 cases of complication per 1000 surgeries. Furthermore, Dabbs and Lauretti (1995) stated that the incidence of serious adverse event or death associated with NSAID use is 100–400 times higher than that of the spinal manipulation.

In contrast, Ernst (2007) argued that the incidence figures might be over-optimistic or nonsensical, because none of these reports considered under-reporting of incidences, while under-reporting was found to be close to 100% (Dupeyron et al., 2003; Stevinson et al., 2001). The author also suggested that if under-reporting was taken into consideration, this might significantly distort the incidence figures.

Taken together, in light of the above evidence, it can be said that spinal manipulation is certainly associated with serious complications but the risk of serious adverse events is statistically low. However, even though serious complications of manipulation might well be minor, in matters of patients’ safety the risk of vascular accidents, stroke or death is not negligible. To admit best interests of the recipient, the practitioners should therefore perform a thorough and meticulous pre-manipulative examination to rule out all contraindications and red flag symptoms so that the patient is not at unwarranted risk.

Contraindications to Spinal Manipulation

There are a number of contraindications to spinal manipulation. These range from an inappropriate condition for such an intervention, where the patient is not likely to benefit from the procedure, to a risky condition, where manipulation may result in life-threatening complications. These contraindications are provided to help practitioners with decision-making so that they do not place a patient at risk of a serious complication following spinal manipulation.

Note: The presence of a contraindicated condition in one area of the spine does not mean that spinal manipulation should not be used in other areas. In many instances, manipulation is contraindicated in one area of the spine, yet it has shown to be favourable for another region (Gatterman, 1992).

Absolute and Relative Contraindications

In general, clinical contraindications to manipulation can be divided into absolute, where manipulation should not be performed because it can place a patient at risk for an adverse event, and relative, where the intervention should be modified and provided with appropriate care so that the patient is not at undue risk. Absolute contraindications comprise a number of diseases and conditions, including bone diseases, congenital conditions, metabolic processes, vertebrobasilar arterial insufficiency, spinal cord compression, and many more (see Table 4.4). Relative contraindications include inflammatory joint processes, minor osteoporosis, disc prolapse and protrusion, hypermobility or ligamentous laxity, spondylolisthesis, degenerative joint diseases, to name a few (see Table 4.5).

Table 4.4 Absolute contraindications for spinal manipulation
Authors	Contraindicated diseases or conditions
World Health Organization (2005); Gibbons and Tehan (2004); Liem and Dobler (2014); Wainapel and Fast (2003); Koss (1990)	Articular derangement •Inflammatory conditions (e.g. rheumatoid arthritis, seronegative spondyloarthropathies such as ankylosing spondylitis, reactive arthritis or psoriatic arthritis, demineralisation or ligamentous laxity with anatomical subluxation or dislocation) •Fractures and dislocations, or healed fractures with signs of ligamentous rupture or instability •Atlantoaxial instability Note: Subacute and chronic ankylosing spondylitis and other chronic arthropathies without any signs of ligamentous laxity, anatomic subluxation or ankylosis are not contraindicated at the area of pathology. Bone diseases •Active juvenile avascular necrosis (particularly of the joints that bear weight of the body) •Acute infections (e.g. osteomyelitis, bone tuberculosis and septic discitis) •Metabolic (osteomalacia) •Anomalies (e.g. spina bifida, dens hypoplasia, dysplasia, diastematomyelia, deformations of the spine, unstable os odontoideum) •Tumour-like and dysphasic bone lesions •Iatrogenic (long treatment with cortisone) Tumours, metastases •Spinal cord tumour •Malignant bone tumour •Meningeal tumour •Aggressive types of benign tumours (e.g. an aneurismal bone cyst, giant cell tumour, osteoblastoma or osteoid osteoma)
	Neurological disorders •Frank disc herniation with accompanying signs of neurological deficit •Cervical myelopathy •Meningitis •Spinal cord compression •Nerve compression syndrome •Intracranial hypertension •Cauda equina syndrome •Hydrocephalus of unknown aetiology Vascular disorders •Serious bleeding diathesis (haemophilia, anticoagulation) •Insufficiency/stenosis of the vertebral/carotid artery •Vertebrobasilar insufficiency syndrome •Vascular calcification of the arterial walls •Arterial tortuosity syndrome •Aortic aneurysm

Table 4.5 Relative contraindications
Mentioned by some authors	Contraindicated diseases or conditions
Croibier and Meddeb (2006); Cagnie et al. (2004); Thanvi et al. (2005)	Vascular and morphological pathology •Venous thrombosis •Angina pectoris •Signs of arteriosclerotic disease, either direct or indirect •High levels of homocysteine •Past history of heart attack •Abnormalities of the lumbosacral/craniocervical junction (e.g. basilar invagination) •Vertebral osteosynthesis
Greenman (2005)	•Genetic disorders (e.g. Down syndrome)
World Health Organization (2005)	•Haematomas, whether intracanalicular or spinal cord •Dislocation of a vertebra •Neoplastic disease of muscle or other soft tissue •Positive Kernig’s or Lhermitte’s signs •Arnold-Chiari malformation of the cervical spine •Syringomyelia
Vickers and Zollman (1990)	•Acute post-traumatic instability (e.g. ligamentous rupture)
	•
Giles and Singer (1997); Giles and Singer (2000)	•Congenital, generalised hypermobility •Synovial cysts in the area of the thoracic spine •Visceral referred pain •Obvious spinal deformity •General hypermobility •Long-term anticoagulant therapy
Koss (1990)	•Acute whiplash •Acute vertigo
Wainapel and Fast (2003)	•Osteoporosis •Spondylolisthesis
Note: Conditions in italics represent relative-to-absolute contraindication to manipulation at the area of pathology.

Red Flags

Red flag symptoms for spinal manipulation (see box below) have been identified to help clinicians in making sound clinical judgements as part of the examination process. In general, these symptoms indicate the presence of a more serious underlying condition that may place the recipient at undue risk (Refshauge et al., 2002). It has been recommended that red flags should be used in conjunction with contraindications to determine the appropriateness of the manipulative procedure and prevent adverse events that may result from manipulation (Childs et al., 2005).

If any of the red flag symptoms mentioned below are present in a patient, the practitioner should prioritise sound clinical reasoning and exercise utmost caution, so that the patient is not placed at risk for an undue adverse event following manipulation.

Red Flags for Spinal Manipulation

•Previous diagnosis of vertebrobasilar insufficiency

•Signs and symptoms of spondylitis and spondylolisthesis

•Previous history of joint or segment surgery

•Facial/intra-oral anaesthesia or paraesthesia

•History of long-term steroid therapy

•History of traumatic event suffering

•Women at post-menopause

•Patients with psychogenic complaints

•Patients with nystagmus

•Presence of osteopenia

•Presence of scoliosis