Association between chiropractic spinal manipulation and cauda equina syndrome in adults with low back pain: Retrospective cohort study of US academic health centers.

BACKGROUND: Cauda equina syndrome (CES) is a lumbosacral surgical emergency that has been associated with chiropractic spinal manipulation (CSM) in case reports. However, identifying if there is a potential causal effect is complicated by the heightened incidence of CES among those with low back pain (LBP). The study hypothesis was that there would be no increase in the risk of CES in adults with LBP following CSM compared to a propensity-matched cohort following physical therapy (PT) evaluation without spinal manipulation over a three-month follow-up period. METHODS: A query of a United States network (TriNetX, Inc.) was conducted, searching health records of more than 107 million patients attending academic health centers, yielding data ranging from 20 years prior to the search date (July 30, 2023). Patients aged 18 or older with LBP were included, excluding those with pre-existing CES, incontinence, or serious pathology that may cause CES. Patients were divided into two cohorts: (1) LBP patients receiving CSM or (2) LBP patients receiving PT evaluation without spinal manipulation. Propensity score matching controlled for confounding variables associated with CES. RESULTS: 67,220 patients per cohort (mean age 51 years) remained after propensity matching. CES incidence was 0.07% (95% confidence intervals [CI]: 0.05-0.09%) in the CSM cohort compared to 0.11% (95% CI: 0.09-0.14%) in the PT evaluation cohort, yielding a risk ratio and 95% CI of 0.60 (0.42-0.86; p = .0052). Both cohorts showed a higher rate of CES during the first two weeks of follow-up. CONCLUSIONS: These findings suggest that CSM is not a risk factor for CES. Considering prior epidemiologic evidence, patients with LBP may have an elevated risk of CES independent of treatment. These findings warrant further corroboration. In the meantime, clinicians should be vigilant to identify LBP patients with CES and promptly refer them for surgical evaluation.

Benefits and Harms of Spinal Manipulative Therapy for Treating Recent and Persistent Nonspecific Neck Pain: A Systematic Review With Meta-analysis.

OBJECTIVE: We aimed to estimate the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. DESIGN: Intervention systematic review with meta-analysis of randomized controlled trials (RCTs). LITERATURE SEARCH: We searched the MEDLINE, Cochrane CENTRAL, Embase, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022. STUDY SELECTION CRITERIA: RCTs evaluating SMT compared to guideline-recommended and nonrecommended interventions, sham SMT, and no intervention for adults with neck pain were eligible for our systematic review. Prespecified outcomes included pain, range of motion, disability, health-related quality of life. DATA SYNTHESIS: Random-effects meta-analysis for clinically homogenous RCTs at short-term and long-term outcomes. Risk of bias was assessed using the Cochrane Risk of Bias 2.0 Tool. We used the Grading of Recommendations, Assessment, Development, and Evaluations approach to judge the certainty of evidence. RESULTS: We included 28 RCTs. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short term (standardized mean difference [SMD], 0.66; 95% confidence interval [CI]: 0.35, 0.97) and long term (SMD, 0.73; 95% CI: 0.31, 1.16), and for reducing disability at short-term (SMD, 0.95; 95% CI: 0.48, 1.42) and long term (SMD, 0.65; 95% CI: 0.23, 1.06). Transient side effects only were found (eg, muscle soreness). CONCLUSION: There was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. J Orthop Sports Phys Ther 2023;53(9):510-528. Epub: 10 August 2023. doi:10.2519/jospt.2023.11708.

Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review.

OBJECTIVES: To describe if there has been a change in the reporting of adverse events associated with spinal manipulation in randomised clinical trials (RCTs) since 2016. DESIGN: A systematic literature review. DATA SOURCES: Databases were searched from March 2016 to May 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro and Cochrane Library. The following search terms and their derivatives were adapted for each platform: spinal manipulation; chiropractic; osteopathy; physiotherapy; naprapathy; medical manipulation and clinical trial. METHODS: Domains of interest (pertaining to adverse events) included: completeness and location of reporting; nomenclature and description; spinal location and practitioner delivering manipulation; methodological quality of the studies and details of the publishing journal. Frequencies and proportions of studies reporting on each of these domains were calculated. Univariable and multivariable logistic regression models were fitted to examine the effect of potential predictors on the likelihood of studies reporting on adverse events. RESULTS: There were 5399 records identified by the electronic searches, of which 154 (2.9%) were included in the analysis. Of these, 94 (61.0%) reported on adverse events with only 23.4% providing an explicit description of what constituted an adverse event. Reporting of adverse events in the abstract has increased (n=29, 30.9%) while reporting in the results section has decreased (n=83, 88.3%) over the past 6 years. Spinal manipulation was delivered to 7518 participants in the included studies. No serious adverse events were reported in any of these studies. CONCLUSIONS: While the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication 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.

Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial.

INTRODUCTION: Chronic low back pain (CLBP) is a highly prevalent and disabling condition. Identifying subgroups of patients afflicted with CLBP is a current research priority, for which a classification system based on pain mechanisms was proposed. Spinal manipulative therapy (SMT) is recommended for the management of CLBP. Yet, little data are available regarding its mechanisms of action, making it difficult to match this intervention to the patients who may benefit the most. It was suggested that SMT may influence mechanisms associated with central sensitisation. Therefore, classifying patients with CLBP according to central sensitisation mechanisms may help predict their response to SMT. METHODS AND ANALYSIS: This protocol describes a randomised placebo-controlled trial aiming to examine which variables linked to central sensitisation may help predict the clinical response to SMT in a cohort of patients with CLBP. One hundred patients with chronic primary low back pain will be randomised to receive 12 sessions of SMT or placebo SMT over a 4-week period. Pain intensity and disability will be assessed as primary outcomes after completing the 4-week treatment (primary endpoint), and at 4-week and 12-week follow-ups. Baseline values of two pain questionnaires, lumbar pressure pain thresholds, concentrations of an inflammatory cytokine and expectations of pain relief will be entered as predictors of the response to SMT in a multiple regression model. Changes in these variables after treatment will be used in a second multiple regression model. The reference values of these predictors will be measured from 50 age and sex-matched healthy controls to allow interpretation of values in patients. Mixed analyses of variance will also be conducted to compare the primary outcomes and the predictors between groups (SMT vs placebo) over time (baseline vs post-treatment). ETHICS AND DISSEMINATION: Ethical approval was granted by the Fundación Jiménez Díaz Clinical Research Ethics Committee. TRIAL REGISTRATION NUMBER: NCT05162924.

Identifying Patient Characteristics Associated With the Occurrence of Post Treatment Non-serious Adverse Events After Cervical Spine Manual Therapy Treatment in Patients With Neck Pain.

OBJECTIVES: To compare prevalence rates of serious and non-serious adverse events after manipulation and mobilization and to identify risk factors of serious and non-serious adverse events following 4 types of manual therapy treatment in patients with neck pain. DESIGN: A prospective cohort study in primary care manual therapy practice. PARTICIPANTS: Patients with neck pain (N=686) provided data on adverse events after 1014 manipulation treatments, 829 mobilization treatments, 437 combined manipulation and mobilization treatments, and 891 treatments consisting of "other treatment modality". INTERVENTIONS: Usual care manual therapy. MAIN OUTCOME MEASURES: A chi-square test was performed to explore differences in prevalence rates. Logistic regression analysis was performed within the 4 treatment groups. A priori we defined associations between patient-characteristics and adverse events of odds ratio (OR)>2 or OR<0.5 as clinically relevant. RESULTS: No serious adverse events, such as cervical artery dissection or stroke, were reported. With regard to non-serious adverse events, we found that these are common after manual therapy treatment: prevalence rates are ranging from 0.3% to 64.7%. We found a statistically significant difference between the 4 types of treatments, detrimental to mobilization treatment. Logistic regression analysis resulted in 3 main predictors related to non-serious adverse events after manual therapy treatment: smoking (OR ranges from 2.10 [95% confidence interval [CI] 1.37-3.11] to 3.33 [95% CI 1.83-5.93]), the presence of comorbidity (OR ranges from 2.32 [95% CI 1.22-4.44] to 3.88 [95% CI 1.62-9.26]), and female sex (OR ranges from 0.22 [95% CI 0.11-0.46] to 0.49 [95% CI 0.28-0.86]). CONCLUSION: There is a significant difference in the occurrence of non-serious adverse events after mobilization compared with manipulation or a combination of manipulation and mobilization. Non-serious adverse events in manual therapy practice are common and are associated with smoking and the presence of comorbidity. In addition, women are more likely to report non-serious adverse events.

Association between cervical artery dissection and spinal manipulative therapy -a medicare claims analysis.

BACKGROUND: Cervical artery dissection and subsequent ischemic stroke is the most serious safety concern associated with cervical spinal manipulation. METHODS: We evaluated the association between cervical spinal manipulation and cervical artery dissection among older Medicare beneficiaries in the United States. We employed case-control and case-crossover designs in the analysis of claims data for individuals aged 65+, continuously enrolled in Medicare Part A (covering hospitalizations) and Part B (covering outpatient encounters) for at least two consecutive years during 2007-2015. The primary exposure was cervical spinal manipulation; the secondary exposure was a clinical encounter for evaluation and management for neck pain or headache. We created a 3-level categorical variable, (1) any cervical spinal manipulation, 2) evaluation and management but no cervical spinal manipulation and (3) neither cervical spinal manipulation nor evaluation and management. The primary outcomes were occurrence of cervical artery dissection, either (1) vertebral artery dissection or (2) carotid artery dissection. The cases had a new primary diagnosis on at least one inpatient hospital claim or primary/secondary diagnosis for outpatient claims on at least two separate days. Cases were compared to 3 different control groups: (1) matched population controls having at least one claim in the same year as the case; (2) ischemic stroke controls without cervical artery dissection; and (3) case-crossover analysis comparing cases to themselves in the time period 6-7 months prior to their cervical artery dissection. We made each comparison across three different time frames: up to (1) 7 days; (2) 14 days; and (3) 30 days prior to index event. RESULTS: The odds of cervical spinal manipulation versus evaluation and management did not significantly differ between vertebral artery dissection cases and any of the control groups at any of the timepoints (ORs 0.84 to 1.88; p > 0.05). Results for carotid artery dissection cases were similar. CONCLUSION: Among Medicare beneficiaries aged 65 and older who received cervical spinal manipulation, the risk of cervical artery dissection is no greater than that among control groups.

Chiropractic Management of Neck Pain Complicated by Symptomatic Vertebral Artery Stenosis and Dizziness.

BACKGROUND Vertebrobasilar insufficiency (VBI) is most often caused by vertebrobasilar atherosclerosis, often presenting with dizziness and occasionally neck pain. Little research or guidelines regarding management of neck pain in affected patients exists. CASE REPORT A 62-year-old male hypertensive smoker presented to a chiropractor with a 13-year history of insidious-onset neck pain, dizziness, and occipital headache with a Dizziness Handicap Inventory (DHI) of 52%. The patient had known VBI, caused by bilateral vertebral artery plaques, and cervical spondylosis, and was treated with multiple cardiovascular medications. The chiropractor referred patient to a neurosurgeon, who cleared him to receive manual therapies provided manual-thrust cervical spinal manipulative therapy (SMT) was not performed. The chiropractor administered thoracic SMT and cervicothoracic soft tissue manipulation. The neck pain and dizziness mostly resolved by 1 month. At 1-year follow-up, DHI was 0%; at 2 years it was 8%. A literature search revealed 4 cases in which a chiropractor used manual therapies for a patient with VBI. Including the present case, all patients had neck pain, 60% had dizziness, and all were treated with SMT either avoiding manual cervical manipulation altogether or modifying it to avoid or limit cervical rotation, yielding positive outcomes. CONCLUSIONS The present and previous cases provide limited evidence that some carefully considered chiropractic manual therapies can afford patients with VBI relief from concurrent neck pain and possibly dizziness. Given the paucity of research, cervical SMT cannot be recommended in such patients. These findings do not apply to vertebral artery dissection, for which SMT is an absolute contraindication.

Clinical decision-making for spinal manipulation for persistent spinal pain following lumbar surgery: a protocol for a systematic review and meta-analysis of individual participant data.

INTRODUCTION: There are limited available research and guidance regarding the use of spinal manipulative therapy (SMT) in patients with low back-related symptoms following lumbar spine surgery, a condition called persistent spinal pain syndrome type 2 (PSPS-2). This publication outlines a review protocol to identify and synthesise individual participant data (IPD) to examine associations between patient, clinical and surgical variables and SMT application in adults with PSPS-2. METHODS AND ANALYSIS: PubMed, OVID, Web of Science, Scopus, PEDro, Index to Chiropractic Literature and KoreaMed will be searched from inception to 1 January 2022 without language restrictions. Case reports, series, observational studies and cases from grey literature of adults receiving SMT for PSPS-2 will be included. Two investigators will independently screen citations, abstracts and full-text articles. A risk-of-bias assessment will be performed in duplicate to rate cases according to exposure and outcome ascertainment and data completeness. Data extraction will be performed in duplicate and missing IPD will be requested from corresponding authors. Multiple binary logistic regression will be used to identify independent predictors of the use of lumbar-SMT, lumbar-manual-thrust SMT and SMT within 1-year postsurgery. Patient, clinical and surgical variables will be summarised using descriptive statistics, while SMT-related outcomes (lumbar-SMT, lumbar-manual-thrust SMT and 1-year surgery-to-SMT interval) will be described using adjusted ORs with 95% CIs. ETHICS AND DISSEMINATION: This study was deemed not human subjects research by the University Hospitals' institutional review board. The results of this review will be disseminated at conferences and/or published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021250039.

Clinical Efficacy and Safety of "Three-Dimensional Balanced Manipulation" in the Treatment of Cervical Spondylotic Radiculopathy by Finite Element Analysis.

Cervical spondylotic radiculopathy (CSR) is the most commonly encountered cervical spine disorder. Cervical manipulation has been demonstrated as an effective therapy for patients. However, the mechanisms of manipulations have not been elucidated. A total of 120 cervical spondylotic radiculopathy patients were divided into the "three-dimensional balanced manipulation" treatment group (TBM group) and control group randomly. The control group was treated with traditional massage; the TBM treatment group was treated with "three-dimensional balanced manipulation" based on traditional massage. The symptoms and clinical efficacy of the patients were compared before and after treatment for one month. A three-dimensional finite element model was established. The mechanical parameters were imported to simulate TBM, and finite element analysis was performed. The results showed that the total effective rate was significantly higher in the TBM group compared with the control group. The biomechanical analysis showed the vertebral body stress was mainly distributed in the C3/4 spinous processes; the deformation mainly concentrated in the anterior processes of the C3 vertebral body. The intervertebral disc stress in the C3~C7 segment was mainly distributed in the anterior part of the C3/4 intervertebral disc, and the deformation extends to the posterior part of the C3/4 nucleus pulposus. In summary, these data are suggesting that TBM was effective in CSR treatment. The results of the finite element model and biomechanical analysis provide an important foundation for effectively avoiding iatrogenic injuries and improving the effect of TBM in the treatment of CSR patients.

Serious adverse events following lumbar spine mobilization or manipulation and potential associated factors: a systematic review protocol.

OBJECTIVES: The objectives of this review are to describe the serious adverse events reported in the literature following lumbopelvic mobilization and manipulation, and identify patient, provider, and/or treatment factors that may be associated with serious adverse events after these interventions. INTRODUCTION: Spinal mobilization and manipulation are types of conservative care commonly used to treat people with low back pain and other musculoskeletal conditions of the lumbar spine and pelvis. Although most adverse events following these interventions are benign and transient, serious adverse events have been reported mostly following spinal manipulative therapy. Given the significant impact serious adverse events can have on patients' lives, identifying factors that may be associated with serious adverse events following spinal mobilization and manipulation of the low back and pelvis would allow for a more specific pre-treatment screening, potentially reducing the occurrence of serious adverse events following these popular interventions and contributing to a safer treatment delivery. INCLUSION CRITERIA: This review will consider interventional and observational studies that report serious adverse events following lumbopelvic spinal mobilization or manipulation experienced by people of any age. Examples of serious adverse events include disc herniation, cauda equina syndrome, and vertebral fracture. METHODS: MEDLINE, Embase, CINAHL, PubMed, The Cochrane Database of Systematic Reviews/Central Register of Controlled Trials, and Index to Chiropractic Literature (ICL) databases will be searched as well as OpenGrey and ProQuest Dissertations and Theses. Two independent reviewers will screen titles and abstracts of identified references as well as the full text of identified studies, and extract data following a standardized data extraction form. Data will be summarized, categorized, and a comprehensive narrative summary will be presented. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42019122339.

Predicting who responds to spinal manipulative therapy using a short-time frame methodology: Results from a 238-participant study.

BACKGROUND: Spinal manipulative therapy (SMT) is among the nonpharmacologic interventions that has been recommended in clinical guidelines for patients with low back pain, however, some patients appear to benefit substantially more from SMT than others. Several investigations have examined potential factors to modify patients' responses prior to SMT application. The objective of this study was to determine if the baseline prediction of SMT responders can be improved through the use of a restricted, non-pragmatic methodology, established variables of responder status, and newly developed physical measures observed to change with SMT. MATERIALS AND METHODS: We conducted a secondary analysis of a prior study that provided two applications of standardized SMT over a period of 1 week. After initial exploratory analysis, principal component analysis and optimal scaling analysis were used to reduce multicollinearity among predictors. A multiple logistic regression model was built using a forward Wald procedure to explore those baseline variables that could predict response status at 1-week reassessment. RESULTS: Two hundred and thirty-eight participants completed the 1-week reassessment (age 40.0± 11.8 years; 59.7% female). Response to treatment was predicted by a model containing the following 8 variables: height, gender, neck or upper back pain, pain frequency in the past 6 months, the STarT Back Tool, patients' expectations about medication and strengthening exercises, and extension status. Our model had a sensitivity of 72.2% (95% CI, 58.1-83.1), specificity of 84.2% (95% CI, 78.0-89.0), a positive likelihood ratio of 4.6 (CI, 3.2-6.7), a negative likelihood ratio of 0.3 (CI, 0.2-0.5), and area under ROC curve, 0.79. CONCLUSION: It is possible to predict response to treatment before application of SMT in low back pain patients. Our model may benefit both patients and clinicians by reducing the time needed to re-evaluate an initial trial of care.

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy.

BACKGROUND: Approximately 50% of patients who receive spinal manipulative therapy (SMT) experience some kind of adverse event (AE), typically benign and transient in nature. Regardless of their severity, mitigating benign AEs is important to improve patient experience and quality of care. The aim of this study was to identify beliefs, perceptions and practices of chiropractors and patients regarding benign AEs post-SMT and potential strategies to mitigate them. METHODS: Clinicians and patients from two chiropractic teaching clinics were invited to respond to an 11-question survey exploring their beliefs, perceptions and practices regarding benign AEs post-SMT and strategies to mitigate them. Responses were analyzed using descriptive statistics. RESULTS: A total of 39 clinicians (67% response rate) and 203 patients (82.9% response rate) completed the survey. Most clinicians (97%) believed benign AEs occur, and 82% reported their own patients have experienced one. For patients, 55% reported experiencing benign AEs post-SMT, with the most common symptoms being pain/soreness, headache and stiffness. While most clinicians (61.5%) reported trying a mitigation strategy with their patients, only 21.2% of patients perceived their clinicians had tried any mitigation strategy. Clinicians perceived that patient education is most likely to mitigate benign AEs, followed by soft tissue therapy and/or icing after SMT. Patients perceived stretching was most likely to mitigate benign AEs, followed by education and/or massage. CONCLUSIONS: This is the first study comparing beliefs, perceptions and practices from clinicians and patients regarding benign AEs post-SMT and strategies to mitigate them. This study provides an important step towards identifying the best strategies to improve patient safety and improve quality of care.

The safety of spinal manipulative therapy in children under 10 years: a rapid review.

INTRODUCTION: The safety of spinal manipulative therapy (SMT) in children is controversial. We were mandated by the College of Chiropractors of British Columbia to review the evidence on this issue. OBJECTIVES: We conducted a rapid review of the safety of SMT in children (< 10 years). We aimed to: 1) describe adverse events; 2) report the incidence of adverse events; and 3) determine whether SMT increases the risk of adverse events compared to other interventions. EVIDENCE REVIEW: We searched MEDLINE, CINAHL, and Index to Chiropractic Literature from January 1, 1990 to August 1, 2019. We used rapid review methodology recommended by the World Health Organization. Eligible studies (case reports/series, cohort studies and randomized controlled trials) were critically appraised. Studies of high and acceptable methodological quality were included. The lead author extracted data. Data extraction was independently validated by a second reviewer. We conducted a qualitative synthesis of the evidence. FINDINGS: Most adverse events are mild (e.g., increased crying, soreness). One case report describes a severe adverse event (rib fracture in a 21-day-old) and another an indirect harm in a 4-month-old. The incidence of mild adverse events ranges from 0.3% (95% CI: 0.06, 1.82) to 22.22% (95% CI: 6.32, 54.74). Whether SMT increases the risk of adverse events in children is unknown. CONCLUSION: The risk of moderate and severe adverse events is unknown in children treated with SMT. It is unclear whether SMT increases the risk of adverse events in children < 10 years.

The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial.

BACKGROUND: Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in autonomic nervous system (ANS) regulation. A common way to study the ANS is to measure heart rate variability (HRV). It is not known whether deviations in HRV are related to changes in pain perception or to the treatment response to SMT. Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as conditioned pain modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known whether this is predictive of treatment response to SMT. The aim of the study is to examine the effects of SMT on HRV and pain. Further, a secondary aim is to test whether a CPM test can be used to predict treatment response in a population of patients with recurrent and persistent NP. METHOD/DESIGN: A multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference for the treatment modality and provider. The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone. HRV will be measured using a portable heart monitor. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. CPM will be measured with a standardized cold pressor test. Measurements will be performed three times during a 2-week treatment series. DISCUSSION: The study will utilize normal clinical procedures, which should aid the transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine whether a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03576846 . Registered on 3 July 2018.

Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting. REVIEW METHODS: Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored. RESULTS: 47 randomised controlled trials including a total of 9211 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). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference -7.48, -11.50 to -3.47) and small to moderate clinically better improvement in function (SMD -0.41, -0.67 to -0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. 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. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT. CONCLUSION: SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

A risk-benefit assessment strategy to exclude cervical artery dissection in spinal manual-therapy: a comprehensive review.

Cervical artery dissection refers to a tear in the internal carotid or the vertebral artery that results in an intramural haematoma and/or an aneurysmal dilatation. Although cervical artery dissection is thought to occur spontaneously, physical trauma to the neck, especially hyperextension and rotation, has been reported as a trigger. Headache and/or neck pain is the most common initial symptom of cervical artery dissection. Other symptoms include Horner's syndrome and lower cranial nerve palsy. Both headache and/or neck pain are common symptoms and leading causes of disability, while cervical artery dissection is rare. Patients often consult their general practitioner for headache and/or neck pain, and because manual-therapy interventions can alleviate headache and/or neck pain, many patients seek manual therapists, such as chiropractors and physiotherapists. Cervical mobilization and manipulation are two interventions that manual therapists use. Both interventions have been suspected of being able to trigger cervical artery dissection as an adverse event. The aim of this review is to provide an updated step-by-step risk-benefit assessment strategy regarding manual therapy and to provide tools for clinicians to exclude cervical artery dissection. Key messages Cervical mobilization and/or manipulation have been suspected to be able to trigger cervical artery dissection (CAD). However, these assumptions are based on case studies which are unable to established direct causality. The concern relates to the chicken and the egg discussion, i.e. whether the CAD symptoms lead the patient to seek cervical manual-therapy or whether the cervical manual-therapy provoked CAD along with the non-CAD presenting complaint. Thus, instead of proving a nearly impossible causality hypothesis, this study provide clinicians with an updated step-by-step risk-benefit assessment strategy tool to (a) facilitate clinicians understanding of CAD, (b) appraise the risk and applicability of cervical manual-therapy, and (c) provide clinicians with adequate tools to better detect and exclude CAD in clinical settings.

Chiropractic treatment including instrument-assisted manipulation for non-specific dizziness and neck pain in community-dwelling older people: a feasibility randomised sham-controlled trial.

Background: Dizziness in older people is a risk factor for falls. Neck pain is associated with dizziness and responds favourably to neck manipulation. However, it is unknown if chiropractic intervention including instrument-assisted manipulation of the neck in older people with neck pain can also improve dizziness. Methods: This parallel two-arm pilot trial was conducted in Melbourne, Australia over nine months (October 2015 to June 2016). Participants aged 65-85 years, with self-reported chronic neck pain and dizziness, were recruited from the general public through advertisements in local community newspapers and via Facebook. Participants were randomised using a permuted block method to one of two groups: 1) Activator II™-instrument-assisted cervical and thoracic spine manipulation plus a combination of: light massage; mobilisation; range of motion exercises; and home advice about the application of heat, or 2) Sham-Activator II™-instrument-assisted manipulation (set to zero impulse) plus gentle touch of cervical and thoracic spinal regions. Participants were blinded to group allocation. The interventions were delivered weekly for four weeks. Assessments were conducted one week pre- and post-intervention. Clinical outcomes were assessed blindly and included: dizziness (dizziness handicap inventory [DHI]); neck pain (neck disability index [NDI]); self-reported concerns of falling; mood; physical function; and treatment satisfaction. Feasibility outcomes included recruitment rates, compliance with intervention and outcome assessment, study location, success of blinding, costs and harms. Results: Out of 162 enquiries, 24 participants were screened as eligible and randomised to either the chiropractic (n = 13) or sham (n = 11) intervention group. Compliance was satisfactory with only two participants lost to follow up; thus, post-intervention data for 12 chiropractic intervention and 10 sham intervention participants were analysed. Blinding was similar between groups. Mild harms of increased spinal pain or headaches were reported by 6 participants. Costs amounted to AUD$2635 per participant. The data showed a trend favouring the chiropractic group in terms of clinically-significant improvements in both NDI and DHI scores. Sample sizes of n = 150 or n = 222 for dizziness or neck pain disability as the primary outcome measure, respectively, would be needed for a fully powered trial. Conclusions: Recruitment of participants in this setting was difficult and expensive. However, a larger trial may be feasible at a specialised dizziness clinic within a rehabilitation setting. Compliance was acceptable and the outcome measures used were well accepted and responsive. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000653763. Registered 13 June 2013.Trial funding: Foundation for Chiropractic Research and Postgraduate Education (Denmark).

Outcomes indicators and a risk classification system for spinal manipulation under anesthesia: a narrative review and proposal.

Over a period of decades chiropractors have utilized spinal manipulation under anesthesia (SMUA) to treat chronic back and neck pain. As an advanced form of manual therapy, SMUA is reserved for the patient whose condition has proven refractory to office-based manipulation and other modes of conservative care. Historically, the protocols and guidelines put forth by chiropractic MUA proponents have served as the clinical compass for directing MUA practice. With many authors and MUA advocates having focused primarily on anticipated benefit, the published literature contains no resource dedicated to treatment precautions and contraindications. Also absent from current relevant literature is acknowledgement or guidance on the preliminary evidence that may predict poor clinical outcomes with SMUA. This review considers risk and unfavorable outcomes indicators in therapeutic decision making for spinal manipulation under anesthesia. A new risk classification system is proposed that identifies patient safety and quality of care interests for a procedure that remains without higher-level research evidence. A scale which categorizes risk and outcome potential for SMUA is offered for the chiropractic clinician, which aims to elevate the standard of care and improve patient selection through the incorporation of specific indices from existing medical literature.

Cervical Epidural Hematoma That Induced Sudden Paraparesis After Cervical Spine Massage: Case Report and Literature Review.

BACKGROUND: Most people understand spinal manipulation therapy to be a safe procedure, and in many cases treatment is provided without a diagnosis if there is musculoskeletal pain. Cervical epidural hematoma occurs in extremely rare cases after cervical manipulation therapy. This study reports a case of epidural hematoma that occurred in the anterior spinal cord after cervical massage. CASE DESCRIPTION: A 38-year-old male patient was admitted to the emergency department for sudden weakness in the lower extremity after receiving a cervical spine massage. No fracture was found using cervical radiographs, and there were no particular findings on performing brain computed tomography or diffusion magnetic resonance imaging. However, using cervical magnetic resonance imaging, an acute epidural hematoma was observed in the anterior spinal cord from the C6 and C7 vertebrae to the T1 vertebra, compressing the spinal cord. There were no fractures or ligament injury. No surgical treatment was required as the patient showed spontaneous improvements in muscle strength and was discharged after just 1 week, following observation of the improvement in his symptoms. CONCLUSION: Although cervical epidural hematoma after cervical manipulation therapy is extremely rare, if suspected, a thorough examination must be performed in order to reduce the chances of serious neurologic sequelae.