Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review

INTRODUCTION Spinal and peripheral joint manipulation and mobilization are interventions used by many healthcare providers to manage musculoskeletal conditions. Although there are many reports of adverse events (or undesirable outcomes) following such interventions, there is no common definition for an adverse event or clarity on any severity classification. This impedes advances of patient safety initiatives and practice. This scoping review mapped the evidence of adverse event definitions and classification systems following spinal and peripheral joint manipulation and mobilization for musculoskeletal conditions in adults. METHODS An electronic search of the following databases was performed from inception to February 2021: MEDLINE, EMBASE, CINAHL, Scopus, AMED, ICL, PEDro, Cochrane Library, Open Grey and Open Theses and Dissertations. Studies including adults (18 to 65 years old) with a musculoskeletal condition receiving spinal or peripheral joint manipulation or mobilization and providing an adverse event definition and/or classification were included. All study designs of peer-reviewed publications were considered. Data from included studies were charted using a standardized data extraction form and synthesised using narrative analysis. RESULTS From 8248 identified studies, 98 were included in the final synthesis. A direct definition for an adverse event and/or classification system was provided in 69 studies, while 29 provided an indirect definition and/or classification system. The most common descriptors to define an adverse event were causality, symptom severity, onset and duration. Twenty-three studies that provided a classification system described only the end anchors (e.g., mild/minor and/or serious) of the classification while 26 described multiple categories (e.g., moderate, severe). CONCLUSION A vast array of terms, definition and classification systems were identified. There is no one common definition or classification for adverse events following spinal and peripheral joint manipulation and mobilization. Findings support the urgent need for consensus on the terms, definition and classification system for adverse events related to these interventions

Assessing forces during spinal manipulation and mobilization: factors influencing the difference between forces at the patient-table and clinician-patient interfaces

Spinal manipulative therapy (SMT) and mobilization (MOB) effects are believed to be related to their force characteristics. Most previous studies have either measured the force at the patient-table interface or at the clinician-patient interface. The objectives of this study were to determine 1) the difference between the force measured at the patient-table interface and the force applied at the clinician-patient interface during thoracic SMT and MOB, and 2) the influence of the SMT/MOB characteristics, participants’ anthropometry and muscle activity (sEMG) on this difference

A Reference Database of Standardised Continuous Lumbar Intervertebral Motion Analysis for Conducting Patient-Specific Comparisons

Lumbar instability has long been thought of as the failure of lumbar vertebrae to maintain their normal patterns of displacement. However, it is unknown what these patterns consist of. Research using quantitative fluoroscopy (QF) has shown that continuous lumbar intervertebral patterns of rotational displacement can be reliably measured during standing flexion and return motion using standardised protocols and can be used to assess patients with suspected lumbar spine motion disorders. However, normative values are needed to make individualised comparisons. One hundred and thirty-one healthy asymptomatic participants were recruited and performed guided flexion and return motion by following the rotating arm of an upright motion frame. Fluoroscopic image acquisition at 15fps was performed and individual intervertebral levels from L2-3 to L5-S1 were tracked and analysed during separate outward flexion and return phases. Results were presented as proportional intervertebral motion representing these phases using continuous means and 95%CIs, followed by verification of the differences between levels using Statistical Parametric Mapping (SPM). A secondary analysis of 8 control participants matched to 8 patients with chronic, non-specific low back pain (CNSLBP) was performed for comparison. One hundred and twenty-seven asymptomatic participants’ data were analysed. Their ages ranged from 18 to 70 years (mean 38.6) with mean body mass index 23.8 kg/m2 48.8% were female. Both the flexion and return phases for each level evidenced continuous change in mean proportional motion share, with narrow confidence intervals, highly significant differences and discrete motion paths between levels as confirmed by SPM. Patients in the secondary analysis evidenced significantly less L5-S1 motion than controls (p < 0.05). A reference database of spinal displacement patterns during lumbar (L2-S1) intersegmental flexion and return motion using a standardised motion protocol using fluoroscopy is presented. Spinal displacement patterns in asymptomatic individuals were found to be distinctive and consistent for Edited by: Babak Bazrgari, University of Kentucky, United States Reviewed by: Navid Arjmand, Sharif University of Technology, Iran Ameet Krishnan Aiyangar, Swiss Federal Laboratories for Materials Science and Technology, Switzerland *Correspondence: Alan Breen [email protected] Specialty section: This article was submitted to Biomechanics, a section of the journal Frontiers in Bioengineering and Biotechnology Received: 22 July 2021 Accepted: 08 September 2021 Published: 27 September 2021 Citation: Breen A, De Carvalho D, Funabashi M, Kawchuk G, Pagé I, Wong AYL and Breen A (2021) A Reference Database of Standardised Continuous Lumbar Intervertebral Motion Analysis for Conducting Patient- Specific Comparisons. Front. Bioeng. Biotechnol. 9:745837. doi: 10.3389/fbioe.2021.745837 Frontiers in Bioengineering and Biotechnology | www.frontiersin.org 1 September 2021 | Volume 9 | Article 745837 ORIGINAL RESEARCH published: 27 September 2021 doi: 10.3389/fbioe.2021.745837 each intervertebral level, and to continuously change during bending and return. This database may be used to allow continuous intervertebral kinematics to drive dynamic models of joint and muscular forces as well as reference values against which to make patient-specific comparisons in suspected cases of lumbar spine motion disorders

A newmethod to analyze the subjective visual vertical in patients with bilateral vestibular dysfunction

OBJECTIVE: The aim of this study was to assess the subjective visual vertical in patients with bilateral vestibular dysfunction and to propose a new method to analyze subjective visual vertical data in these patients. METHODS: Static subjective visual vertical tests were performed in 40 subjects split into two groups. Group A consisted of 20 healthy volunteers, and Group B consisted of 20 patients with bilateral vestibular dysfunction. Each patient performed six measurements of the subjective visual vertical test, and the mean values were calculated and analyzed. RESULTS: Analyses of the numerical values of subjective visual vertical deviations (the conventional method of analysis) showed that the mean deviation was 0.326±1.13º in Group A and 0.301±1.87º in Group B. However, by analyzing the absolute values of the subjective visual vertical (the new method of analysis proposed), the mean deviation became 1.35±0.48º in Group A and 2.152±0.93º in Group B. The difference in subjective visual vertical deviations between groups was statistically significant (p

Software for subjective visual vertical assessment: an observational cross-sectional study

Spatial orientation in relation to the gravitational axis is significantly important for the maintenance of the posture, gait and for most of the human's motor activities. The subjective visual vertical exam evaluates the individual's perception of vertical orientation. Objectives: The aims of this study were (1) to develop a virtual system to evaluate the subjective visual vertical exam, (2) to provide a simple tool to clinical practice and (3) to assess the subjective visual vertical values of h ealthy subjects using the new software. Study Design: observational cross-sectional study. Methods: Thirty healthy volunteers performed the subjective visual vertical exam in both static and dynamic conditions. The exam consisted in adjusting a virtual line in the vertical position using the computer mouse. For the static condition, the virtual line was projected in a white background. For the dynamic condition, black circles rotated in clockwise or counterclockwise directions. Six measurements were taken and the mean deviations in relation to the real vertical calculated. Results: The mean values of subjective visual vertical measurements were: static -0.372 degrees; +/- 1.21; dynamic clockwise 1.53 degrees +/- 1.80 and dynamic counterclockwise -1.11 degrees +/- 2.46. Conclusion: This software showed to be practical and accurate to be used in clinical routines.FAPESP (Fundacao de Apoio a Pesquisa do Estado de Sao Paulo)Fundacao de Apoio a Pesquisa do Estado de Sao Paulo (FAPESP)CAPES (Coordenacao de Aperfeicoamento de Pessoal de nivel Superior)Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES)CNPq (Centro Nacional de Pesquisa)CNPq (Centro Nacional de Pesquisa

Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Needling Therapies for Chronic Primary Low Back Pain in Adults

PURPOSE Evaluate benefits and harms of needling therapies (NT) for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline. METHODS Electronic databases were searched for randomized controlled trials (RCTs) assessing NT compared with placebo/sham, usual care, or no intervention (comparing interventions where the attributable effect could be isolated). We conducted meta-analyses where indicated and graded the certainty of evidence. RESULTS We screened 1831 citations and 109 full text RCTs, yeilding 37 RCTs. The certainty of evidence was low or very low across all included outcomes. There was little or no difference between NT and comparisons across most outcomes; there may be some benefits for certain outcomes. Compared with sham, NT improved health-related quality of life (HRQoL) (physical) (2 RCTs; SMD = 0.20, 95%CI 0.07; 0.32) at 6 months. Compared with no intervention, NT reduced pain at 2 weeks (21 RCTs; MD = - 1.21, 95%CI - 1.50; - 0.92) and 3 months (9 RCTs; MD = - 1.56, 95%CI - 2.80; - 0.95); and reduced functional limitations at 2 weeks (19 RCTs; SMD = - 1.39, 95%CI - 2.00; - 0.77) and 3 months (8 RCTs; SMD = - 0.57, 95%CI - 0.92; - 0.22). In older adults, NT reduced functional limitations at 2 weeks (SMD = - 1.10, 95%CI - 1.71; - 0.48) and 3 months (SMD = - 1.04, 95%CI - 1.66; - 0.43). Compared with usual care, NT reduced pain (MD = - 1.35, 95%CI - 1.86; - 0.84) and functional limitations (MD = - 2.55, 95%CI - 3.70; - 1.40) at 3 months. CONCLUSION Based on low to very low certainty evidence, adults with CPLBP experienced some benefits in pain, functioning, or HRQoL with NT; however, evidence showed little to no differences for other outcomes

Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Structured and Standardized Education or Advice for Chronic Primary low back pain in Adults

PURPOSE: Evaluate benefits and harms of education/advice for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline. METHODS: Electronic databases were searched for randomized controlled trials (RCTs) assessing education/advice compared with placebo/sham, usual care, or no intervention (including comparison interventions where the attributable effect of education/advice could be isolated). We conducted meta-analyses and graded the certainty of evidence. RESULTS: We screened 2514 citations and 86 full text RCTs and included 15 RCTs. Most outcomes were assessed 3 to 6 months post-intervention. Compared with no intervention, education/advice improved pain (10 RCTs, MD = -1.1, 95% CI -1.63 to -0.56), function (10 RCTs, SMD = -0.51, 95% CI -0.89 to -0.12), physical health-related quality of life (HRQoL) (2 RCTs, MD = 24.27, 95% CI 12.93 to 35.61), fear avoidance (5 RCTs, SMD = -1.4, 95% CI -2.51 to -0.29), depression (1 RCT; MD = 2.10, 95% CI 1.05 to 3.15), and self-efficacy (1 RCT; MD = 4.4, 95% CI 2.77 to 6.03). Education/advice conferred less benefit than sham Kinesio taping for improving fear avoidance regarding physical activity (1 RCT, MD = 5.41, 95% CI 0.28 to 10.54). Compared with usual care, education/advice improved pain (1 RCT, MD = -2.10, 95% CI -3.13 to -1.07) and function (1 RCT, MD = -7.80, 95% CI -14.28 to -1.32). There was little or no difference between education/advice and comparisons for other outcomes. For all outcomes, the certainty of evidence was very low. CONCLUSION: Education/advice in adults with CPLBP was associated with improvements in pain, function, HRQoL, and psychological outcomes, but with very low certainty

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

INTRODUCTION 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. METHODS AND ANALYSIS This international multidisciplinary electronic Delphi study protocol is informed by a scoping review and in accordance with the 'Guidance on Conduction and Reporting Delphi Studies'. With oversight from an expert steering committee, the study comprises three rounds using online questionnaires. Experts in manual therapy and patient safety meeting strict eligibility criteria from the following fields will be invited to participate: clinical, medical and legal practice, health records, regulatory bodies, researchers and patients. Round 1 will include open-ended questions on participants' working definition and/or understanding of AEs following SMT and MOB and their severity classification. In round 2, participants will rate their level of agreement with statements generated from round 1 and our scoping review. In round 3, participants will rerate their agreement with statements achieving consensus in round 2. Statements reaching consensus must meet the a priori criteria, as determined by descriptive analysis. Inferential statistics will be used to evaluate agreement between participants and stability of responses between rounds. Statements achieving consensus in round 3 will provide an expert-derived definition and classification system for AEs following SMT and MOB. ETHICS AND DISSEMINATION This study was approved by the Canadian Memorial Chiropractic College Research Ethics Board and deemed exempt by Parker University's Institutional Review Board. Results will be disseminated through scientific, professional and educational reports, publications and presentations