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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. 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. 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). 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.

Spinal and peripheral joint manipulation (MAN) and mobilization (MOB) are widely used for managing musculoskeletal conditions. Although adverse events (AE) have been reported following these interventions, there is no universally accepted definition and classification system. This study aimed to establish an inter-professional and international standardized definition and severity classification for AE following MAN and MOB. This sequential mixed-methods study included an electronic Delphi process (e-Delphi) followed by focus groups. Inter-professional and international expert stakeholders participated in 3 e-Delphi rounds: Round 1 included open-ended questions on participants’ working AE definition and severity classification; Round 2, level of agreement with statements generated from Round 1 and a previous scoping review; and Round 3, level of agreement with statements achieving consensus in Round 2. Focus groups explored e-Delphi findings. Consensus was reached for severity categories (i.e., mild, moderate, severe and catastrophic) and on 2 domains to differentiate these categories (i.e., symptom intensity and impact on patient). Consensus was not reached for a standardized AE definition following MAN and MOB. Focus group discussions centered on “unfavourable”, “unexpected” and “undesired” terms and differences between “serious” and “catastrophic” severity classification categories. Findings contribute to advancing patient safety and AE knowledge across professions and informing further safety research and practice.

Although reduced experimental pain habituation is proposed as a proxy of diminished endogenous pain modulatory capacity in chronic pain, prior studies show contradictory findings. Even across healthy participants, pain habituation varies substantially, which may relate to another measure of endogenous pain modulation, i.e., conditioned pain modulation (CPM). Hence, this study investigated the relationship between pain habituation and CPM. Pain habituation was assessed in 45 healthy participants between two blocks of 15–20 contact-heat stimuli applied to the hand. Habituation of subjective pain ratings and objective neurophysiological readouts (contact-heat evoked potential (CHEP) and palmar sympathetic skin response (SSR)) was investigated. CPM was assessed by comparing heat pain thresholds before and after hand immersion in a noxious cold (9 °C) and lukewarm water bath (32 °C, to control for repeated measures effects). Pain habituation showed a large variability, with subjective but not objective pain habituation correlating with cold-induced CPM effects (r = 0.50; p  = 0.025). This correlation was not observed for ‘true’ CPM effects (corrected for repeated measures effects) nor for CPM effects induced by a lukewarm water bath. These findings suggest that the observed variability in subjective pain habituation may be influenced by both descending endogenous pain modulation and peripheral adaptation processes associated with repeated measures. Objective pain habituation readouts, i.e., CHEPs and SSRs, capture different, complementary aspects of endogenous pain modulation.

Background Spinal manipulation (MAN) and mobilization (MOB) are biomechanically different yet both elicit pain reduction and increased range of motion. Previous investigations have focused on quantifying kinetics (e.g., applied forces) or, recipient kinematics (i.e., movements) during MAN and MOB. While these studies provide valuable information, they do not report on the strategies adopted by providers when performing the complex motor tasks of MAN and MOB. This review sought to synthesise the literature reporting on provider kinematics during the delivery of MAN and MOB. Methods This scoping literature review is reported following the Preferred Reporting Items for Scoping Reviews (PRISMA-ScR) statement. MEDLINE (Ovid), PsychINFO, Cochrane Library, Web of Science, Embase, Scopus, PEDro, ICL and CINAHL databases were searched from inception to September 2023 for terms relating to provider kinematics during the delivery of MAN and MOB. Data were extracted and reported descriptively, including: general study characteristics, number and characteristics of individuals who delivered/received MAN and/or MOB, region treated, equipment used and kinematic parameters of the individual delivering the procedure. Results Of 4,844 records identified, five (0.1%) fulfilled the eligibility criteria and were included in the analysis. Of these, provider kinematics were reported for the delivery of MAN in four (80%) and for the delivery of MOB in one (20%) article. Practitioners applied the procedure in all (100%) and students in one (20%) study. Spinal regions treated were: lumbar ( n  = 4), thoracic ( n  = 2) and cervical ( n  = 1). Data were reported heterogeneously but were most commonly captured using either video or motion capture equipment ( n  = 4, 80%). The direction of applied force was fully reported in one (20%) and only partially reported (one spinal region) in another study. Conclusions There are a small number of studies reporting heterogeneously on provider kinematics during the delivery of MAN and MOB. Clear reporting of the procedure from a biomechanical perspective and of the measurement equipment used could enable future meta-analysis of provider kinematic data, the use of provider kinematic data in the development of technique skills curricula and could feasibly be used to mitigate risk of injury for providers.

ObjectivesTo describe if there has been a change in the reporting of adverse events associated with spinal manipulation in randomised clinical trials (RCTs) since 2016.DesignA systematic literature review.Data sourcesDatabases 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.MethodsDomains 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.ResultsThere 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.ConclusionsWhile 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.

Background As 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. Methods All 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. Results Eighty-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). Conclusion Substantial 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.

Background Spinal manipulation (SM) is a recommended and effective treatment for musculoskeletal disorders. Biomechanical (kinetic) parameters (e.g. preload/peak force, rate of force application and thrust duration) can be measured during SM, quantifying the intervention. Understanding these force-time characteristics is the first step towards identifying possible active ingredient/s responsible for the clinical effectiveness of SM. Few studies have quantified SM force-time characteristics and with considerable heterogeneity evident, interpretation of findings is difficult. The aim of this study was to synthesise the literature describing force-time characteristics of manual SM. Methods This scoping literature review is reported following the Preferred Reporting Items for Scoping Reviews (PRISMA-ScR) statement. Databases were searched from inception to October 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro and Cochrane Library. The following search terms and their derivatives were adapted for each platform: spine, spinal, manipulation, mobilization or mobilisation, musculoskeletal, chiropractic, osteopathy, physiotherapy, naprapathy, force, motor skill, biomechanics, dosage, dose-response, education, performance, psychomotor, back, neck, spine, thoracic, lumbar, pelvic, cervical and sacral. Data were extracted and reported descriptively for the following domains: general study characteristics, number of and characteristics of individuals who delivered/received SM, region treated, equipment used and force-time characteristics of SM. Results Of 7,607 records identified, 66 (0.9%) fulfilled the eligibility criteria and were included in the analysis. Of these, SM was delivered to the cervical spine in 12 (18.2%), the thoracic spine in 40 (60.6%) and the lumbopelvic spine in 19 (28.8%) studies. In 6 (9.1%) studies, the spinal region was not specified. For SM applied to all spinal regions, force-time characteristics were: preload force (range: 0-671N); peak force (17-1213N); rate of force application (202-8700N/s); time to peak thrust force (12-938ms); and thrust duration (36-2876ms). Conclusions Considerable variability in the reported kinetic force-time characteristics of SM exists. Some of this variability is likely due to differences in SM delivery (e.g. different clinicians) and the measurement equipment used to quantify force-time characteristics. However, improved reporting in certain key areas could facilitate more sophisticated syntheses of force-time characteristics data in the future. Such syntheses could provide the foundation upon which dose-response estimates regarding the clinical effectiveness of SM are made.

Spinal mobilization (SMob) is often included in the conservative management of spinal pain conditions as a recommended and effective treatment. While some studies quantify the biomechanical (kinetic) parameters of SMob, interpretation of findings is difficult due to poor reporting of methodological details. The aim of this study was to synthesise the literature describing force-time characteristics of manually applied SMob. This study is reported in accordance with the Preferred Reporting Items for Scoping Reviews (PRISMA-ScR) statement. Databases were searched from inception to October 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro and Cochrane Library. Data were extracted and reported descriptively for the following domains: general study characteristics, number of and characteristics of individuals who delivered/received SMob, region treated, equipment used and force-time characteristics of SMob. There were 7,607 records identified and of these, 36 (0.5%) were included in the analysis. SMob was delivered to the cervical spine in 13 (36.1%), the thoracic spine in 3 (8.3%) and the lumbopelvic spine in 18 (50.0%) studies. In 2 (5.6%) studies, spinal region was not specified. For SMob applied to all spinal regions, force-time characteristics were: peak force (0-128N); duration (10-120s); frequency (0.1-4.5Hz); and force amplitude (1-102N). This study reports considerable variability of the force-time characteristics of SMob. In studies reporting force-time characteristics, SMob was most frequently delivered to the lumbar and cervical spine of humans and most commonly peak force was reported. Future studies should focus on the detailed reporting of force-time characteristics to facilitate the investigation of clinical dose-response effects.

Background Spinal manipulative therapy is an effective treatment for neck pain. However, the mechanisms underlying its clinical efficacy are not fully understood. Previous studies have not systematically compared force-time parameters and electromyographic responses associated with spinal manipulation. In this study, force-time parameters and electromyographic characteristics associated with multiple manual high-velocity, low-amplitude cervical and upper thoracic spinal manipulations were investigated. The purpose of this analysis was to compare the force-time parameters and electromyographic characteristics between two spinal manipulations delivered following one another in quick succession if the first thrust was not associated with an audible cavitation. Methods Nine asymptomatic and eighteen symptomatic participants received six Diversified-style spinal manipulations to the cervical and upper thoracic spines during data collected February 2018 to September 2019. Peak force, rate of force application and thrust duration were measured using a pressure pad. Bipolar surface electrodes were used to measure the electromyographic responses and reflex delay times in sixteen neck, back and limb outlet muscles bilaterally. Differences in force-time parameters and electromyographic data were analyzed between the first and second thrust. Results Fifty-two spinal manipulations were included in this analysis. Peak force was greater ( p  < 0.001) and rate of force application faster ( p  < 0.001) in the second thrust. Furthermore, peak electromyographic responses were higher following the second thrust in asymptomatic ( p  < 0.001) and symptomatic ( p  < 0.001) subjects. Also, electromyographic delays were shorter in the symptomatic compared to the asymptomatic participants for the second thrust ( p  = 0.039). There were no adverse patient events. Conclusion When a second manipulation was delivered because there was not audible cavitation during the first thrust, the second thrust was associated with greater treatment forces and faster thrust rates. Peak electromyographic responses were greater following the second thrust.

IntroductionSpinal 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 analysisThis 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 disseminationThis 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.