The risk associated with spinal manipulation: an overview of reviews (10.1186/s13643-017-0458-y)
Cerebral Hemorrhage Following Chiropractic Activator Treatment – Case Report and Review of Literature (10.1055/s-0036-1597626):The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT [Spinal manipulative therapy] is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe.It is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.
Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases (10.1186/s12874-017-0320-x) :Background Despite widespread utilization of chiropractic treatment for various ailments, there is a paucity of documentation regarding intracerebral hemorrhage related to chiropractic trauma. Stroke has been reported from cervical manipulation, although with a suggested low incidence. Activator treatment, an instrument that produces a high-velocity, low-amplitude impact to the spine, is considered especially safe. There are no prior reports of intracerebral hemorrhage resulting from a chiropractic activator treatment.Case Description A 75-year-old woman was admitted to the hospital with a history of headaches, visual difficulties on the right, and speech disturbance of relatively acute onset. CT scan showed a brain hemorrhage in an unusual location. Extensive evaluation was undertaken because this was thought to be a spontaneous event. No cause was found on imaging. Subsequent history revealed a chiropractic activator treatment applied directly to the junction of the back of her head and the upper cervical spine immediately prior to the onset of symptoms. Her clinical course is described.Conclusions This appears to be the first report linking traumatic intracerebral hemorrhage with a chiropractic activator treatment. The use of this modality in an elderly population, with widespread utilization of anticoagulants and platelet inhibitors, is of potential concern.
Results Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database.Conclusions While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We recommend the development of standardized definitions and reporting tools for adverse events associated with SMT. Adequate reporting of adverse events associated with SMT will facilitate accurate indexing of these types of manuscripts in the databases.
Safety of thrust joint manipulation in the thoracic spine: a systematic review (10.1179/2042618615Y.0000000012) :(...) [from main text] (...)
The purpose of a randomized clinical trial (RCT) is to collect and appropriately report both beneficial and harmful effects from an intervention and to compare these outcomes across groups. However, it is far more common for RCTs and in turn, systematic reviews, to focus on the beneficial effects of an intervention versus harms data when reporting results .
Compensation claims for chiropractic in Denmark and Norway 2004–2012 ( 10.1186/s12998-014-0037-4):Results: Ten cases, reported in 7 case reports, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years (SD=18.73, Range = 17 -71). The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10), with pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10).Limitations: There were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.Conclusions: Serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.
Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial (10.1186/1471-2474-15-77):Methods All finalized compensation claims involving chiropractors reported to one of the two associations between 2004 and 2012 were assessed for age, gender, type of complaint, decisions and appeals. Descriptive statistics were used to describe the study population.Results 338 claims were registered in Denmark and Norway between 2004 and 2012 of which 300 were included in the analysis. 41 (13.7%) were approved for financial compensation. The most frequent complaints were worsening of symptoms following treatment (n = 91, 30.3%), alleged disk herniations (n = 57, 19%) and cases with delayed referral (n = 46, 15.3%). A total financial payment of €2,305,757 (median payment €7,730) were distributed among the forty-one cases with complaints relating to a few cases of cervical artery dissection (n = 11, 5.7%) accounting for 88.7% of the total amount.Conclusion Chiropractors in Denmark and Norway received approximately one compensation claim per 100.000 consultations. The approval rate was low across the majority of complaint categories and lower than the approval rates for general practioners and physiotherapists. Many claims can probably be prevented if chiropractors would prioritize informing patients about the normal course of their complaint and normal benign reactions to treatment.
The Quality of Reports on Cervical Arterial Dissection following Cervical Spinal Manipulation (https://doi.org/10.1371/journal.pone.0059170):Methods Participants were recruited among patients, ages 18–65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249), 2) manual therapy excluding spinal manipulation (n = 258) and 3) manual therapy excluding stretching (n = 260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms.Results The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR = 2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR = 2.49 (95% CI: 1.77-3.52)) compared to men.Conclusion Adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.
Results Overall, 43 articles reported 901 cases of CAD [cervical artery dissection] and 707 incidents of stroke reported to be associated with cSMT. The most common type of stroke reported was ischemic stroke (92%). Time-to-onset of symptoms was reported most frequently (95%). No single case included all 11 factors.Conclusions This study has demonstrated that the literature infrequently reports useful data toward understanding the association between cSMT, CADs and stroke. Improving the quality, completeness, and consistency of reporting adverse events may improve our understanding of this important relation.
Cervical Arterial Dissections and Association With Cervical Manipulative Therapy | Stroke(...) [main text] (...)
While the reporting of rare events occurs frequently in larger studies (such as randomized control trials (RCTs)), the event is often not reported with sufficient details. Furthermore, systematic reviews where harms have been reported often exclude non-RCTs , which can minimize useful information about the benefit-to-harm ratio associated with treatment. Given these circumstances, harms reporting often occurs through community-based passive surveillance, which is well known for under-reporting. Despite this limitation, the majority of emerging harms data still arise from case reports, making the quality of these reports essential. Recognizing this, the Cochrane Adverse Effects Methods Group  has recommended that when harms are infrequent, systematic reviews should include non-RCT study designs; an approach that requires high quality reporting of case materials to allow for meaningful interpretation.
Conclusions—CD [cervical artery dissection] is an important cause of ischemic stroke in young and middle-aged patients. CD is most prevalent in the upper cervical spine and can involve the internal carotid artery or vertebral artery. Although current biomechanical evidence is insufficient to establish the claim that CMT causes CD, clinical reports suggest that mechanical forces play a role in a considerable number of CDs and most population controlled studies have found an association between CMT and VAD stroke in young patients. Although the incidence of CMT-associated CD in patients who have previously received CMT is not well established, and probably low, practitioners should strongly consider the possibility of CD as a presenting symptom, and patients should be informed of the statistical association between CD and CMT prior to undergoing manipulation of the cervical spine.Craniocervical arterial dissections as sequelae of chiropractic manipulation: patterns of injury and management | Journal of Neurosurgery, Vol 115, No 6 (http://dx.doi.org/10.3171/2011.8.JNS111212) :
Deaths after chiropractic: a review of published cases - Ernst - 2010 - International Journal of Clinical Practice (Results Thirteen patients (8 women and 5 men, mean age 44 years, range 30–73 years) presented with neurological deficits, head and neck pain, or both, typically within hours or days of chiropractic manipulation. Arterial dissections were identified along the entire course of the vertebral artery, including the origin through the V4 segment. Three patients had vertebral artery dissections that continued rostrally to involve the basilar artery. Two patients had dissections of the internal carotid artery (ICA): 1 involved the cervical ICA and 1 involved the petrocavernous ICA. Stenting was performed in 5 cases, and thrombolysis of the basilar artery was performed in 1 case. Three patients underwent emergency cerebellar decompression because of impending herniation. Six patients were treated with medication alone, including either anticoagulation or antiplatelet therapy. Clinical follow-up was obtained in all patients (mean 19 months). Three patients had permanent neurological deficits, and 1 died of a massive cerebellar stroke. The remaining 9 patients recovered completely. Of the 12 patients who survived, radiographic follow-up was obtained in all but 1 of the most recently treated patients (mean 12 months). All stents were widely patent at follow-up.Conclusions Chiropractic manipulation of the cervical spine can produce dissections involving the cervical and cranial segments of the vertebral and carotid arteries. These injuries can be severe, requiring endovascular stenting and cranial surgery. In this patient series, a significant percentage (31%, 4/13) of patients were left permanently disabled or died as a result of their arterial injuries.
Design: This study is a systematic review of case reports.Chiropractic and stroke: association or causation? - Tuchin - 2013 - International Journal of Clinical Practice - Wiley Online Library
Methods: Literature searches in four electronic databases with no restrictions of time or language.
Main outcome measure: Death.
Results: Twenty six fatalities were published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery.
Conclusion: Numerous deaths have occurred after chiropractic manipulations. The risks of this treatment by far outweigh its benefit.
Serious complications following spinal manipulative therapy (SMT) of the cervical spine, including stroke, are relatively rare. Estimates vary between 1 : 400,000 cervical spine manipulations and 1 : 5.6 million [1, 2]. However, there is controversy on how frequent events such as stroke are, and whether there is a causal relationship with SMT. Even more controversy can be found specifically relating to chiropractic SMT and whether this has a higher risk than other types of SMT. Both sides of the debate appear to have extremists with a biased perspective. Previous articles have not provided a comprehensive review of the evidence for and against chiropractic. A recent article noted several weaknesses or inconsistencies in some articles discussing chiropractic treatment and stroke . A critical review of a paper previously published in the International Journal of Clinical Practice has been conducted to provide evidence for the alternative theories regarding the safety of chiropractic SMT and whether there is a causal relationship with the stroke . A critical review of the current literature will also help to assess any misconceptions or distortion of the results of studies on chiropractic and stroke.Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial - Chaibi - 2016 - European Journal of Neurology - Wiley Online Library
Acute paraplegia after chiropraxis
Migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow-up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow-up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT. Conclusions It is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.
Spinal manipulation is a form of back and other musculoskeletal pain treatment that often involves a high-velocity thrust, a technique in which the joints are adjusted rapidly. The main objective of chiropractors is to correct spinal malalignment and relieve the nerves, allowing them to function optimally (Ernst In: Expert Rev Neurother 7:1451–1452, 2007; Oppenheim et al. In: Spine J 5:660–666, 2005). The evidence for the effectiveness of this treatment based on randomized clinical trials still remains uncertain (Cassidy et al. In: Spine 33(4 suppl): S176–S183, 2008; Dupeyron et al. In: Ann Readapt Med Phys 46:33–40, 2003; Ernst et al. In: Expert Rev Neurother 7:1451–1452, 2007; Hurwitz et al. In: J Manipulative Physiol Ther 27:16–25, 2007; Thiel et al. In: Spine 32: 2375–2378, 2007). Several case reports and series have been focusing on the risks of chiropraxis, especially on the cervical spine, although the risk/benefit ratio for certain selected patients could be acceptable (Powell et al.In: Neurosurgery 33:73–78, 1993). We describe the case of a 45-year-old woman who suffered complete paraplegia shortly after a chiropractic maneuver in the thoracic spine. Dorsal CT showed a calcified disc herniation at the T8–T9 level and MRI revealed a diffuse spinal cord ischemia from T6 to the conus medullaris without spinal cord compression at the level of herniation. Despite a normal arteriography, authors suggest a vascular injury as the cause of the deficit.