Dataset Information

The risk associated with spinal manipulation: an overview of reviews.

ABSTRACT:

Background

Spinal manipulative therapy (SMT) is a widely used manual treatment, but many reviews exist with conflicting conclusions about the safety of SMT. We performed an overview of reviews to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.

Methods

We searched five electronic databases from inception to December 8, 2015. We included reviews on any type of studies, patients, and SMT technique. Our primary outcome was SAEs. Quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, we used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated.

Results

We identified 283 eligible reviews, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT 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.

Conclusions

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.

Systematic review registration

PROSPERO CRD42015030068 .

SUBMITTER: Nielsen SM

PROVIDER: S-EPMC5366149 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Publications

The risk associated with spinal manipulation: an overview of reviews.

Nielsen Sabrina Mai SM Tarp Simon S Christensen Robin R Bliddal Henning H Klokker Louise L Henriksen Marius M

Systematic reviews 20170324 1

<h4>Background</h4>Spinal manipulative therapy (SMT) is a widely used manual treatment, but many reviews exist with conflicting conclusions about the safety of SMT. We performed an overview of reviews to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT.<h4>Methods</h4>We searched five electronic databases from inception to December 8, 2015. We included reviews on any type of studies, patients, and SMT technique. Our primary outcome was SAEs. Quality of the inc ...[more]

PMID: 28340595

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Project description:The clinical use of spinal manipulation to treat musculoskeletal conditions has nearly tripled in the United States since 1980, and it is currently recommended by most global clinical guidelines as a conservative treatment for musculoskeletal pain, despite a lack of knowledge concerning its mechanisms of action. This overview highlights evidence of direct neuromuscular responses to high-velocity, low-amplitude spinal manipulation (HVLA-SM) as delivered by chiropractic, osteopathic, and physical therapy clinicians, with an intent to foster greater interprofessional dialogue and collaborative research to better address current gaps in mechanistic knowledge of the neuromuscular response to HVLA-SM. Three databases (PubMed, CINAHL Ultimate (EBSCO), EMBASE (Elsevier)) were searched from 2000 to December 2024 with specific search terms related to thrust HVLA-SM and the neuromuscular response. To focus strictly on neuromuscular responses related to HVLA-SM, this literature overview excluded articles using non-HVLA-SM manual therapy techniques (i.e., massage, non-thrust joint mobilization, and/or combined HVLA-SM with other forms of treatment such as exercise or non-thrust joint mobilization) and studies in which patient-centered outcomes (i.e., pain scores) were the primary outcomes of the HVLA-SM interventions. Pediatric studies, animal studies, and studies in languages other than English were also excluded. One-hundred and thirty six articles were identified and included in this overview. Neuromuscular findings related to HVLA-SM in the areas of electromyography (EMG), muscle thickness, muscle strength, reflexes, electroencephalogram (EEG), and evoked potential were often mixed; however, evidence is beginning to accumulate either in favor of or opposed to particular neuromuscular responses to HVLA-SM as larger and more scientifically rigorous studies are being performed. Recurrent limitations of many HVLA-SM-related studies are small sample sizes, leading to a lack of generalizability, and the non-standardization of HVLA-SM delivery, which has prevented researchers from arriving at definitive conclusions regarding neuromuscular responses to HVLA-SM. Discussions of future neuromuscular research needs related to HVLA-SM are included for clinicians and researchers inside and outside of the field of manual therapy, to advance this field.

Project description:BACKGROUND: Eczema is the most common inflammatory skin disease of childhood, characterized by an itchy red rash that usually involves the face and skin folds. There is currently no curative treatment for eczema, so the reduction of eczema incidence through disease prevention is a desirable goal. Potential interventions for preventing eczema include exclusive breastfeeding, hydrolysed protein formulas and soy formulas when bottle feeding, maternal antigen avoidance, omega oil supplementation, prebiotics and probiotics. OBJECTIVES: This overview of reviews aims to present the current body of data from Cochrane and non-Cochrane reviews to provide the most up-to-date evidence on the efficacy and safety of interventions to prevent eczema in infants and children at different risk levels for developing allergic disease. METHODS: Our pool of Cochrane and non-Cochrane reviews came from the 2010 United Kingdom National Health Service (NHS) Evidence Skin Disorders Annual Evidence Updates Mapping Exercise on Atopic Eczema. This group used a comprehensive search strategy last conducted in August 2010 to identify all systematic reviews on eczema prevention. We identified all reviews that met our pre-specified inclusion criteria, and data were extracted, analysed, compiled into tables and synthesized using quantitative and qualitative methods. MAIN RESULTS: Seven systematic reviews containing 39 relevant trials with 11 897 participants were included in this overview. Overall, there was no clear evidence that any of the main interventions reviewed reduced eczema incidence. In subgroup analyses of infants at high risk of allergic disease, an observational study found that exclusive breastfeeding for at least six months compared with introduction of solids at three to six months decreased the incidence of eczema by 60% (risk ratio (RR): 0.40; 95% confidence interval (CI): 0.21, 0.78), and a randomized controlled trial found that prebiotics compared with no prebiotics decreased incidence by 58% (RR: 0.42; 95% CI: 0.21, 0.84). However, each of these findings was based on the results of a single small trial, and no intervention reduced eczema incidence beyond the first two years of life. Although we pre-specified incidence of atopic eczema (i.e. eczema associated with immunoglobulin E (IgE) sensitization) as a primary outcome, data on whether participants diagnosed with eczema were truly atopic were largely lacking from systematic reviews. Similarly, data on atopy, measured using skin prick tests or specific IgE tests to allergens, were not reported in many reviews. No interventions were found to decrease atopy when reported. Adverse events data were generally lacking, but data from a trial of probiotics versus no probiotics showed significantly more spitting up in the first one (RR: 1.88; 95% CI: 1.03, 3.45) and two (RR: 1.69; 95% CI: 1.02, 2.80) months of life, but no overall increase in risk of gastrointestinal symptoms in the first year. AUTHORS#ENTITYSTARTX02019; CONCLUSIONS: Although there is currently no clear evidence showing that any of the interventions examined in this overview prevent eczema in participants not selected for risk of allergic disease, there is some evidence that exclusive breastfeeding for at least six months and prebiotics might reduce eczema incidence in high-risk participants. However, these conclusions are based on limited evidence with methodological shortcomings. Future research on prevention of eczema is needed and should examine different types of hydrolysed formulas, prebiotics and probiotics, as well as enhancement of the skin barrier and other novel approaches in infants at different risk levels for developing allergic disease.

Project description:BackgroundAdverse drug events (ADEs) occurring in hospital inpatients can have serious implications. The ability to identify and prioritize patients at higher risk of ADEs could help pharmacists to optimize their impact as members of the patient care team.ObjectiveTo identify risk factors, patient characteristics, and medications associated with a higher likelihood of ADEs in adult inpatients through an overview of reviews on this topic.Data sourcesSystematic reviews and narrative reviews or guidelines identified through a search of MEDLINE and the Cochrane Database of Systematic Reviews (limited to articles published from 1995 to June 4, 2015), as well as a grey literature search.Study selection and data extractionFor inclusion in this overview, a review had to discuss patient characteristics or risk factors associated with ADEs, medications associated with ADEs, or drug-drug interactions associated with ADEs, in adult inpatients. Articles retrieved by the literature search were screened for eligibility by a single reviewer.Data synthesisEleven articles were deemed eligible for inclusion in this overview: 4 systematic reviews and 7 narrative reviews or guidelines. Their results were described narratively. Older age and polypharmacy were the most frequently cited risk factors associated with ADEs in hospital inpatients. Renal impairment, female sex, and decline in cognition were also frequently reported as being associated with ADEs. Medication classes reported to be associated with ADEs during the hospital stay included anticoagulants, anti-infectives/antibiotics, antidiabetic agents, analgesics (including opioids and nonsteroidal anti-inflammatory drugs), and cardiovascular drugs (including antihypertensive agents, diuretics, and digoxin). Two publications reported on preventable ADEs in hospital inpatients; the medications associated with preventable ADEs were consistent with those reported above.ConclusionsThe risk factors, patient characteristics, and medication classes highlighted in this overview may help clinicians to prioritize patient populations who may be at higher risk of ADEs.

Project description:Study designRetrospective cohort study.ObjectiveIn older adults with a neuromusculoskeletal complaint, to evaluate risk of injury to the head, neck, or trunk after an office visit for chiropractic spinal manipulation compared with office visit for evaluation by primary care physician.Summary of background dataThe risk of physical injury due to spinal manipulation has not been rigorously evaluated for older adults, a population particularly vulnerable to traumatic injury in general.MethodsWe analyzed Medicare administrative data on Medicare B beneficiaries aged 66 to 99 years with an office visit in 2007 for a neuromusculoskeletal complaint. Using a Cox proportional hazards model, we evaluated for adjusted risk of injury within 7 days, comparing 2 cohorts: those treated by chiropractic spinal manipulation versus those evaluated by a primary care physician. We used direct adjusted survival curves to estimate the cumulative probability of injury. In the chiropractic cohort only, we used logistic regression to evaluate the effect of specific chronic conditions on likelihood of injury.ResultsThe adjusted risk of injury in the chiropractic cohort was lower than that of the primary care cohort (hazard ratio, 0.24; 95% confidence interval, 0.23-0.25). The cumulative probability of injury in the chiropractic cohort was 40 injury incidents per 100,000 subjects compared with 153 incidents per 100,000 subjects in the primary care cohort. Among subjects who saw a chiropractic physician, the likelihood of injury was increased in those with a chronic coagulation defect, inflammatory spondylopathy, osteoporosis, aortic aneurysm and dissection, or long-term use of anticoagulant therapy.ConclusionAmong Medicare beneficiaries aged 66 to 99 years with an office visit risk for a neuromusculoskeletal problem, risk of injury to the head, neck, or trunk within 7 days was 76% lower among subjects with a chiropractic office visit than among those who saw a primary care physician.Level of evidence3.

Project description:BackgroundAs part of multimodal therapy, spinal manipulation (SM) is a recommended and effective treatment for musculoskeletal pain. However, the underlying physiological mechanisms for pain relief are largely unknown. SM thrusts can be described and quantified using force-time characteristics (e.g. preload force, peak force, thrust speed, thrust duration, and thrust impulse). If these biomechanical parameters of SM are important for clinical outcomes, a large variability in the delivery of SM could lead to inconsistent responses and could thereby potentially mask a significant clinical effect. Our goal was to determine variability, and repeatability of thoracic spinal manipulation (SM) force-time profiles in a sample of Swiss chiropractors.MethodsAll interventions were performed on a human analogue manikin. Participating chiropractors received three case scenarios with the following scenarios: 50-year-old male patient, 30-year-old male athlete, and a 70-year-old female patient, each presenting with uncomplicated musculoskeletal thoracic pain. Clinicians were asked to perform three consecutive thoracic SM thrusts for each of the scenarios and repeated the same interventions after 24-48 h.ResultsEighty-one chiropractors participated in the study, including 32 females (39.5%) with a mean age of 45.22 ± 12.96 years. The variability in SM force-time characteristics between clinicians was substantial, with preload forces ranging from 4.50 to 450.25 N and peak forces ranging from 146.08 to 1285.17 N. Significant differences between case scenarios were observed for peak force (p < 0.0001), maximum thrust speed (p = 0.0002), and thrust impulse (p = 0.0004). Except for thrust duration, repeatability within and between sessions was fair to excellent (ICCs between 0.578 and 0.957).ConclusionSubstantial variability in application of SM was evident across clinicians and between case scenarios. Despite substantial clinician-dependent variability, the high repeatability of thoracic SM thrusts suggests a level of standardization in SM delivery, indicating that chiropractors might have 'their' individual force-time profile that they are capable to reproduce. Further research based on these findings should explore how to enhance the consistency, effectiveness, and safety of thoracic SM delivered clinically to humans.

Dataset Information

The risk associated with spinal manipulation: an overview of reviews.

Background

Methods

Results

Conclusions

Systematic review registration

Publications

The risk associated with spinal manipulation: an overview of reviews.

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