Adverse Events
and Chiropractic Care

	Adverse Events in Children Page A Chiro.Org article collection This page compiles reports on adverse events experienced by children.
	What's the Harm? Results of an Active Surveillance Adverse Reporting System for Chiropractors and Physiotherapists PLoS One 2024 (Aug 19); 19 (8): e0309069 Our community-based active surveillance study found the incidence of AEs following chiropractic or physiotherapy patient encounters to be 21.3%. Of these AE reports, the severity classifications were noted as: mild   (7.9%), moderate   (6.2%), severe   (3.7%), serious   (1.5%), and missing severity responses   (2.0%). This innovative and novel study provides valuable information for clinicians and patients and serves as a framework to more fully understand post-visits AEs more fully and potential strategies to mitigate them.
	Reporting of Adverse Events Associated with Spinal Manipulation in Randomised Clinical Trials: An Updated Systematic Review BMJ Open 2023 (May 4); 13 (5): e067526 While the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication [26] on the same topic, the level remains low and inconsistent with established standards. As such, it is imperative for authors, journal editors and administrators of clinical trial registries to ensure there is more balanced reporting of both benefits and harms in RCTs involving spinal manipulation.
	A Retrospective Analysis of the Incidence of Severe Adverse Events Among Recipients of Chiropractic Spinal Manipulative Therapy Sci Rep 2023 (Jan 23); 13 (1): 1254 This study examined the incidence and severity of adverse events (AEs) of patients receiving chiropractic spinal manipulative therapy (SMT), with the hypothesis that < 1 per 100,000 SMT sessions results in a grade ≥ 3 (severe) AE. A secondary objective was to examine independent predictors of grade ≥ 3 AEs. We identified patients with SMT-related AEs from January 2017 through August 2022 across 30 chiropractic clinics in Hong Kong. AE data were extracted from a complaint log, including solicited patient surveys, complaints, and clinician reports, and corroborated by medical records. AEs were independently graded 1–5 based on severity (1–mild, 2–moderate, 3–severe, 4–life-threatening, 5–death). Among 960,140 SMT sessions for 54,846 patients, 39 AEs were identified, two were grade 3, both of which were rib fractures occurring in women age > 60 with osteoporosis, while none were grade ≥ 4, yielding an incidence of grade ≥ 3 AEs of 0.21 per 100,000 SMT sessions (95% CI 0.00, 0.56 per 100,000). There were no AEs related to stroke or cauda equina syndrome. The sample size was insufficient to identify predictors of grade ≥ 3 AEs using multiple logistic regression. In this study, severe SMT-related AEs were reassuringly very rare.
	Benefits and Harms of Treatments for Chronic Non-Specific Low Back Pain Without Radiculopathy: Systematic Review and Meta-analysis Spine J 2022 (Nov 15); S1529-9430(22)01006-3 There is uncertainty about the benefits and harms of all the interventions reviewed due to the lack of trials conducted in patients with chronic non-specific low back pain without radiculopathy. From the limited trials conducted, non-pharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. However, more research is needed. There were (also) high harms ratings for opioids and surgery.
	Non-serious Adverse Events Do Not Influence Recovery in Patients with Neck Pain Treated with Manual Therapy; An Observational Study Musculoskelet Sci Pract 2022 (Oct); 61: 102607 ~ FULL TEXT We found that the occurrence of non-serious adverse events (NSAEs e.g. aggravation of complaints, stiffness, irradiating pain) did not influence recovery in patients with neck pain treated by physiotherapists with postgraduate qualifications in manual therapy (MT). Currently, there is no need for physiotherapists to consider NSAEs when making prognosis in these patients. But, keeping in mind the criticism on the one-in-ten rule, we cannot exclude the possibility that our study was underpowered.
	Definition and Classification for Adverse Events Following Spinal and Peripheral Joint Manipulation and Mobilization: A Scoping Review PLoS One 2022 (Jul 15); 17 (7): e0270671 Findings identified that a vast array of terms, definitions and classification systems for adverse events following spinal and peripheral joint manipulation and mobilization have been published. Within this array of literature, there was no one standardized adverse event definition or classification system for adverse events following these interventions that is commonplace and widely used. This suggests that establishing a consensus on standardized terms, definitions and classification systems for adverse events related to these interventions is urgently needed and could advance strategies to enhance patient safety for all professions who deliver these interventions.
	Expert Consensus on a Standardised Definition and Severity Classification for Adverse Events Associated with Spinal and Peripheral Joint Manipulation and Mobilisation: Protocol for an International E-Delphi Study BMJ Open 2021 (Nov 11); 11 (11): e050219 ~ FULL TEXT Spinal and peripheral joint manipulation (SMT) and mobilisation (MOB) are widely used and recommended in the best practice guidelines for managing musculoskeletal conditions. Although adverse events (AEs) have been reported following these interventions, a clear definition and classification system for AEs remains unsettled. With many professionals using SMT and MOB, establishing consensus on a definition and classification system is needed to assist with the assimilation of AEs data across professions and to inform research priorities to optimise safety in clinical practice.
	Adverse Events From Spinal Manipulations in the Pregnant and Postpartum Periods: A Systematic Review and Update J Can Chiropr Assoc 2021 (Apr); 65 (1): 32–49 ~ FULL TEXT High quality studies, such as RCTs, regarding SMT for pregnancy- and postpartum-related spinal pain are lacking. This update of our previous review found one case study [93] that demonstrated a serious adverse event following SMT in the cervical spine and a handful of minor and transient adverse events in the low back. [18, 60, 76, 77, 86] Although we are calling for improved reporting of such events in all papers going forward, it appears these events are rare. Future research should focus on the proper reporting of all adverse events while assessing efficacy of appropriate treatment options for these populations.
	Ratings of Perceived Effectiveness, Patient Satisfaction and Adverse Events Experienced by Wellness Chiropractic Patients in a Practice-based Research Network Complement Ther Clin Pract. 2019 (Aug); 36: 82–87 ~ FULL TEXT Wellness patients are predominantly female, rating their care as effective/very effective and with high satisfaction. Adverse events reported were minor (i.e., self-limiting) with a prevalence ranging from 6.3% to 11.3%. Experiencing an AE and the chiropractor providing care had a significant effect on patient satisfaction ratings. We support continued research in characterizing the patterns and utilization of chiropractic services for wellness chiropractic patients.
	Benefits and Harms of Spinal Manipulative Therapy for the Treatment of Chronic Low Back Pain: Systematic Review and Meta-analysis of Randomised Controlled Trials British Medical Journal 2019 (Mar 13); 364: l689 ~ FULL TEXT 47 randomised controlled trials including a total of 9,211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference -3.17, 95% confidence interval -7.85 to 1.51) and a small, clinically better improvement in function (SMD -0.25, 95% confidence interval -0.41 to -0.09). Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT.
	What Are the Risks of Manual Treatment of the Spine? A Scoping Review for Clinicians Chiropractic & Manual Therapies 2017 (Dec 7); 25: 37 ~ FULL TEXT Existing literature indicates that benign adverse events following manual treatments to the spine are common, while serious adverse events are rare. The incidence and causal relationships with serious adverse events are challenging to establish, with gaps in the literature and inherent methodological limitations of studies. Clinicians should ensure that patients are informed of risks during the consent process. Since serious adverse events could result from pre-existing pathologies, assessment for signs or symptoms of these is important. Clinicians may also contribute to furthering understanding by utilising patient safety incident reporting and learning systems where adverse events have occurred.
	Association of Spinal Manipulative Therapy with Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis JAMA. 2017 (Apr 11); 317 (14): 1451–1460 ~ FULL TEXT For the second time in as many months, a prominent medical journal has endorsed spinal manipulation for the management of low back pain. [1] On April 11th 2017, JAMA published a systematic review of 26 randomized clinical trials in order to evaluate the safety and effectiveness of spinal manipulation for low back pain.   The authors concluded:   “Among patients with acute low back pain, spinal manipulative therapy was associated with improvements in pain and function with only transient minor musculoskeletal harms.”
	Serious Adverse Events and Spinal Manipulative Therapy of the Low Back Region: A Systematic Review of Cases J Manipulative Physiol Ther 2015 (Nov); 38 (9): 677–691 ~ FULL TEXT We identified 77 cases involving a serious adverse event following lumbopelvic SMT. Important information such as SMT description, pre-SMT presentation of the patient, and adverse event details were lacking. Cauda equina syndrome and lumbar disk herniation accounted for most adverse events. In addition, we identified cases of spinal fracture, hematoma, hemorrhagic cyst, and other serious adverse events. Two-thirds of cases had a favorable clinical outcome. Additional high-quality research is needed to better estimate the incidence of adverse events associated with lumbopelvic SMT and to elucidate the relationship between this therapy and the types of adverse events reported in this systematic review.
	Adverse Events Due to Chiropractic and Other Manual Therapies for Infants and Children: A Review of the Literature J Manipulative Physiol Ther. 2015 (Nov); 38 (9): 699–712 ~ FULL TEXT Published cases of serious adverse events in infants and children receiving chiropractic, osteopathic, physiotherapy, or manual medical therapy are exceedingly rare. There have been no cases of deaths associated with chiropractic care reported in the academic literature to date. Three deaths were reported caused by other types of manual therapists (1 physical therapist, 1 unknown practitioner, and 1 craniosacral therapist). Performing a thorough history and examination to exclude anatomical or neurologic anomalies before the provision of care, appropriate technique selection and its application may further reduce adverse events across all manual therapy professions.
	Adverse Events Among Seniors Receiving Spinal Manipulation and Exercise in a Randomized Clinical Trial Manual Therapy 2015 (Apr); 20 (2): 335–341 ~ FULL TEXT Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at home. Eight serious, non-related AE also occurred. Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans.
	Development and Validation of Providers’ and Patients’ Measurement Instruments to Evaluate Adverse Events After Spinal Manipulation Therapy Eur J Integr Med. 2014 (Aug); 6 (4): 451–466~ FULL TEXT The development and validation of instruments to evaluate SMT AEs may benefit SMT research by providing the opportunity for rigorous prospective assessment of potential SMT-related AEs and their risk factors. We have developed profession-specific instruments and engaged members of each profession who can act as champions, promoting patient safety culture for community-based SMT providers. Future efforts with these instruments include putting them into providers’ offices for use on consecutive patients in an effort to assess AE after SMT.
	Adverse Reactions of Medications in Children: The Need for Vigilance, A Case Study J Clinical Chiropractic Pediatrics 2014 (Mar); 14 (2) ~ FULL TEXT This study demonstrates that adverse drug reactions do potentially pose a public health risk within the pediatric population and all healthcare providers need to be mindful of this risk. Adverse events to medication within this population are prevalent particularly in children under the age of two. Chiropractors must therefore be aware of adverse drug reactions and recognize symptoms within their patient population.
	Quantifying the Impact of NSAID-associated Adverse Events Am J Manag Care. 2013 (Nov); 19 (14 Suppl): s267–272 ~ FULL TEXT Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used among patients experiencing many different types of pain, including inflammatory, acute pain (eg, injury, low back pain, headache, postoperative pain), and chronic pain (eg, rheumatoid arthritis, osteoarthritis).   However, both traditional NSAIDs and second-generation NSAIDs (cyclooxygenase-2 inhibitors) can lead to very expensive and serious adverse events. Gastrointestinal, cardiovascular, and renal complications associated with NSAIDs have been shown to be dose-dependent. In 2005, to help minimize these risks, the US Food and Drug Administration issued a public health advisory stating that "NSAIDs should be administered at the lowest effective dose for the shortest duration consistent with individual patient treatment goals."
	Outcomes of Usual Chiropractic. The OUCH Randomized Controlled Trial of Adverse Events Spine (Phila Pa 1976). 2013 (Sep 15); 38 (20): 1723–1729 ~ FULL TEXT Completed adverse questionnaires were returned by 94.5% of the participants after appointment 1 and 91.3% after appointment 2. Thirty-three percent of the sham group and 42% of the usual care group reported at least 1 adverse event.   Common adverse events were: increased pain sham 29% usual care 36% muscle stiffness sham 29% usual care 37% headache sham 17% usual care   9% The relative risk (RR) was not significant for adverse event occurrence (RR = 1.24; 95% CI: 0.85-1.81), occurrence of severe adverse events (RR = 1.9; 95% CI: 0.98-3.99), adverse event onset (RR = 0.16; 95% CI: 0.02-1.34), or adverse event duration (RR = 1.13; 95% CI: 0.59-2.18).   No serious adverse events were reported. CONCLUSION:   A substantial proportion of adverse events after chiropractic treatment may result from natural history variation and nonspecific effects.
	Adverse Events From Spinal Manipulation in the Pregnant and Postpartum Periods: A Critical Review of the Literature Chiropractic & Manual Therapies 2012 (Mar 28); 20: 8 ~ FULL TEXT Five articles identifying adverse events in seven subjects following spinal manipulation were included in this review, along with two systematic reviews. The articles were published between 1978 and 2009. Two articles describing adverse effects from spinal manipulation on two postpartum patients were included, while the remaining three articles on five patients with adverse effects following spinal manipulation were on pregnant patients. Injury severity ranged from minor injury such as increasing pain after treatment that resolved within a few days to more severe injuries including fracture, stroke, and epidural hematoma. SIGN scores of the prospective observational cohort study and systematic reviews indicated acceptable quality.
	Possible Adverse Events in Children Treated By Manual Therapy: A Review Chiropractic & Osteopathy 2010 (Jun 2); 18: 12 ~ FULL TEXT Miller and Benfield [16] estimate 1% of pediatric patients (one in 749 treatments) suffered from a minor and self limited AE. A detailed description of the AE allowed the authors to review and classify them. Based on their analysis, three of the events attributed as AE may have been incorrectly attributed as a result of treatment (i.e. pre-existing constipation, common behavior of child, etc.). If these are excluded, the AE rate becomes one reaction per 1310 treatments.
	Safety of Chiropractic Manual Therapy for Children: How Are We Doing? J Clinical Chiropractic Pediatrics 2009 (Dec); 10 (2): 655–660 ~ FULL TEXT Based on the published literature, chiropractic spinal manipulation, when performed by skilled chiropractors, provides very low risk of adverse effect to the pediatric patient. Vigilance to detect occult pathology as well as other steps to maintain safe practice are of utmost importance.
	Benign Adverse Events Following Chiropractic Care for Neck Pain Are Associated With Worse Short-term Outcomes but Not Worse Outcomes at Three Months Spine (Phila Pa 1976) 2008 (Dec 1); 33 (25): E950–956 ~ FULL TEXT Self-reported benign adverse events after chiropractic care for neck pain are associated with worse short-term outcomes. Intense adverse events are associated with more neck disability and clinically relevant differences at the short-term only. However, there is no association between adverse events and worse outcomes at 3 months.
	Adverse Events Following Chiropractic Care for Subjects with Neck or Low-back Pain: Do the Benefits Outweigh the Risks? J Manipulative Physiol Ther. 2008 (Jul); 31 (6): 461–464 ~ FULL TEXT This synopsis provides an overview of the benign and serious risks associated with chiropractic care for subjects with neck or low-back pain. Most adverse events associated with spinal manipulation are benign and self-limiting. The incidence of severe complications following chiropractic care and manipulation is extremely low. The best evidence suggests that chiropractic care is a useful therapy for subjects with neck or low-back pain for which the risks of serious adverse events should be considered negligible.
	Adverse Effects of Spinal Manipulative Therapy in Children Younger Than 3 Years: A Retrospective Study in a Chiropractic Teaching Clinic J Manipulative Physiol Ther 2008 (Jul); 31 (6): 419–423 ~ FULL TEXT This study shows that for the population studied, chiropractic manipulation produced very few adverse effects and was a safe form of therapy in the treatment of patients in this age group.
	The Benefits Outweigh the Risks for Patients Undergoing Chiropractic Care for Neck Pain: A Prospective, Multicenter, Cohort Study J Manipulative Physiol Ther 2007 (Jul); 30 (6): 408–418 ~ FULL TEXT In contrast to clinical trials of prescription medication, researchers in the area of conservative care for musculoskeletal complaints have focused their attention on treatment effectiveness and, to a much lesser degree, on adverse events. This study, consisting of patients treated in a wide variety of chiropractic practices and settings, describes both positive and negative, and short- and long-term clinical outcomes for a relatively large study population with neck pain. Although many of the subjects (in this study) had chronic, recurrent neck pain and had undergone prior care for this complaint, many patients experienced benefit from the treatment (based upon diminished pain and disability, the percentage of patients recovered and percentage satisfied with care). Furthermore, many responded relatively quickly to treatment (48% were recovered at the fourth visit).