Guideline implementation in the Canadian chiropractic setting: a pilot cluster randomized controlled trial and parallel study.

Background: Feasibility and pilot studies are recommended prior to embarking on large-scale costly confirmatory trials. The objectives were to determine the feasibility of conducting a cluster randomized controlled trial (C-RCT) to evaluate a complex knowledge translation (KT) intervention to improve the management of people with neck pain, and to identify challenges and potential solutions to conducting a fully powered C-RCT in the chiropractic setting. Methods: Pilot C-RCT involving a nationally representative sample of chiropractors and patients. We invited 400 chiropractors and 150 patients to participate. Clinicians were randomized to receive either an online theory-based KT educational and brief action plan (BAP) intervention (intervention group) or a copy of a clinical practice guideline (control group). Study-related challenges were ascertained via mid-study phone interviews and end-of-study feedback questionnaires. Analyses focused on descriptive estimates of likely recruitment, retention, and adherence rates, and documentation of potential barriers. Results: In total, 47 chiropractors (12%) agreed to participate and were randomized after resampling. Fifteen withdrew from the study, leaving a total of 32 (8%) participants. Eleven chiropractors in the intervention group completed the webinars and e-learning modules, two partially completed them and three did not register. Participating chiropractors recruited a total of 29 patients. Sixty-three percent (n = 7) of intervention and 56% (n = 10) of control group patients completed all outcome measures at both baseline and 3-months follow-up, attended follow-up visits and performed home exercises. Patients in the intervention group reported significant reductions in pain (mean 1.6, 95% CI 0.26-2.94, P = 0.027) and disability scores (9.8, 95% CI 3.68-15.91, P = 0.033) from baseline to 3-month follow-up. Key barriers to participation reported by chiropractors included lack of time, difficulties in recruiting patients, problems with the administration of study questionnaires, concern that the clinician-patient relationship might be jeopardized, and lack of assistance from office staff. Over half (55%) of the respondents in the intervention group encountered some difficulty registering or completing the educational modules. Conclusion: Recruitment of clinicians and patients for a trial of a complex intervention can be challenging, and retention of participants after enrolment may be low. Future trials of this nature likely require multiple recruitment strategies to achieve desired sample sizes. Moreover, time-constraint issues are perceived particularly by clinicians as a major barrier to both study enrolment before, and protocol adherence during, their actual participation in a trial. Trial registration: The study was registered at, NCT02483091, on 17th June 2015.

A proposed in vitro model for investigating the mechanisms of 'joint cracking': a short report of preliminary techniques and observations.

Joint "cracking" is common but not a clearly understood audible phenomenon. In this brief report we propose an in-vitro model to potentially assist in revealing a mechanism for, and therefore source of, this phenomenon. Using a suction cup under tension and de-nucleated fluid to simulate synovial fluid, an audible release with intra-articular cavity formation was elicited. This was followed by a refractory period during which no audible crack could be elicited until the observed cavity had slowly reabsorbed back into the joint fluid. Conversely, if regular fluid containing pre-existing nuclei was used, a cavity formation occurred but with neither an audible release nor subsequent refractory period. With this simple in-vitro model, we were able to reproduce the characteristic audible release, cavity formation and related refractory period typically observed in related experiments in human joints. This simple in-vitro model may be of use in helping to discern both the timing and precise nature of other yet to be discerned mechanisms related to joint cracking.

Le « craquement ¼ des articulations est un phénomène sonore commun, mais mal compris. Dans ce court rapport, nous proposons un modèle in vitro pouvant aider à révéler un mécanisme, et par conséquent une source, pour ce phénomène. À l'aide d'une ventouse sous tension et d'un fluide énucléé ayant pour but de simuler la synovie, on a entendu un son provenant de la cavité intraarticulaire, suivi d'une période réfractaire au cours de laquelle on n'a pas obtenu de craquement sonore jusqu'à ce que la cavité observée se soit réabsorbée lentement dans le liquide articulaire. À l'inverse, lorsqu'on utilisait le liquide régulier contenant les noyaux préexistants, il se produisait une perforation de la cavité, mais sans son ni période réfractaire. Ce modèle in vitro simple a permis de reproduire le son, la cavité et la période réfractaire connexe caractéristiques qu'on observe en général lors d'expériences connexes sur des articulations humaines. Ce modèle in vitro simple peut aussi servir à discerner à la fois le moment et la nature précise d'autres mécanismes qu'on n'a pas encore perçus concernant le craquement des articulations.

Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

BACKGROUND: Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. METHODS/DESIGN: The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest (recruitment, retention, adherence, pain intensity, Neck Disability Index). DISCUSSION: Results of this study will inform the design of a larger cluster-randomized controlled trial aimed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP. TRIAL REGISTRATION: https://clinicaltrials.gov/, NCT02483091.

The Chiropractic Hospital-Based Interventions Research Outcomes Study: Consistency of Outcomes Between Doctors of Chiropractic Treating Patients With Acute Lower Back Pain.

OBJECTIVE: The aim of this study was to determine if effectiveness differs between community-based doctors of chiropractic administering standardized evidence-based care that includes high-velocity low-amplitude spinal manipulative therapy (SMT) for acute low back pain (LBP). METHODS: A secondary analysis of randomized controlled trial and observational pilot study data was performed with nonrandom allocation to 4 DCs. Patients included those with Quebec Task Force categories less than or equal to 2 and acute LBP of 2 to 4 weeks' duration. The intervention provided was clinical practice guidelines-based care including high-velocity low-amplitude SMT. Primary outcomes included changes from baseline in modified Roland Disability Questionnaire (RDQ) at 24 weeks. Comparisons of simple main effects at 24 weeks and of marginal main effects in repeated-measures analyses were performed. RESULTS: Between groups, adjusted point-specific differences in RDQ change were minimally clinically important but not statistically significant at 24 weeks (largest pairwise difference, -3.1; 95% confidence interval, -6.3 to 0.1; overall P = .10). However, in optimal analyses that considered the repeated nature of the measurements for each outcome, significant differences in marginal mean RDQ changes were found between groups (largest pairwise difference, -3.8; 95% confidence interval, -4.9 to 2.6; overall P = .03). CONCLUSIONS: Overall, DCs differed modestly in their effectiveness in improving LBP-specific disability. The point estimates mirrored typically reported effect sizes from recent systematic reviews of SMT; however, confidence limits did not exclude clinically negligible effects.

Fast tracking the design of theory-based KT interventions through a consensus process.

BACKGROUND: Despite available evidence for optimal management of spinal pain, poor adherence to guidelines and wide variations in healthcare services persist. One of the objectives of the Canadian Chiropractic Guideline Initiative is to develop and evaluate targeted theory- and evidence-informed interventions to improve the management of non-specific neck pain by chiropractors. In order to systematically develop a knowledge translation (KT) intervention underpinned by the Theoretical Domains Framework (TDF), we explored the factors perceived to influence the use of multimodal care to manage non-specific neck pain, and mapped behaviour change techniques to key theoretical domains. METHODS: Individual telephone interviews exploring beliefs about managing neck pain were conducted with a purposive sample of 13 chiropractors. The interview guide was based upon the TDF. Interviews were digitally recorded, transcribed verbatim and analysed by two independent assessors using thematic content analysis. A 15-member expert panel formally met to design a KT intervention. RESULTS: Nine TDF domains were identified as likely relevant. Key beliefs (and relevant domains of the TDF) included the following: influence of formal training, colleagues and patients on clinicians (Social Influences); availability of educational material (Environmental Context and Resources); and better clinical outcomes reinforcing the use of multimodal care (Reinforcement). Facilitating factors considered important included better communication (Skills); audits of patients' treatment-related outcomes (Behavioural Regulation); awareness and agreement with guidelines (Knowledge); and tailoring of multimodal care (Memory, Attention and Decision Processes). Clinicians conveyed conflicting beliefs about perceived threats to professional autonomy (Social/Professional Role and Identity) and speed of recovery from either applying or ignoring the practice recommendations (Beliefs about Consequences). The expert panel mapped behaviour change techniques to key theoretical domains and identified relevant KT strategies and modes of delivery to increase the use of multimodal care among chiropractors. CONCLUSIONS: A multifaceted KT educational intervention targeting chiropractors' management of neck pain was developed. The KT intervention consisted of an online education webinar series, clinical vignettes and a video underpinned by the Brief Action Planning model. The intervention was designed to reflect key theoretical domains, behaviour change techniques and intervention components. The effectiveness of the proposed intervention remains to be tested.

The effect of waiting time on pain intensity after elective surgical lumbar discectomy.

BACKGROUND CONTEXT: Waitlists are commonly used in Canada to manage access to surgical procedures such as elective surgical lumbar discectomy (ESLD). The timing of enrollment onto the waitlist is important as this is a proxy measure for the concordance of preferences for surgery between a patient and surgeon. After enrollment, the waiting time to actual surgery extends the duration of preoperative symptoms, which possibly affects the outcome of ESLD. Waiting time also specifically reflects the delay in service delivery imposed by the limited capacity of the health-care system. PURPOSE: To determine if a system-imposed delay in treatment, that is, longer waiting time, for ESLD is associated with a higher odds of experiencing residual postoperative pain. STUDY DESIGN/SETTING: Ambidirectional cohort study with 2-year retrospective and 3-year prospective components, conducted at a major tertiary care center serving a metropolitan area in Canada. PATIENT SAMPLE: Patients aged 16 years or older with sciatica because of herniated lumbar disc, confirmed on advanced imaging, were recruited at the time of waitlist enrollment for ESLD. Patients with significant comorbidity or emergency indications for surgery were excluded. Of 391 participants, 291 had complete follow-up information at 6 months postoperatively. OUTCOME MEASURE: Intensity of the predominant symptom (worse of either back or leg pain) was assessed on the 11-point numerical rating scale at waitlist enrollment and 6 months postoperatively. Pain scores were highly skewed and therefore categorized into four ordinal levels defined by quartiles. METHODS: For the primary analysis, time to surgery from waitlist enrollment was dichotomized based on a predetermined clinically meaningful cut-point of 12 weeks. Ordinal logistic regression was used to compare the odds of experiencing higher pain intensity between wait groups. Control of confounders was achieved using both propensity scores and conventional multivariable modeling. RESULTS: In unadjusted analyses, long-wait patients were 80% more likely than short-wait patients to experience higher ordinal pain intensity at 6 months; unadjusted proportional odds ratio (POR)=1.8 (95% confidence interval [CI], 1.2-2.8). The association held after controlling for all imbalances in measured confounders, with long-wait patients still being 70% more likely to report worse pain; adjusted POR=1.7 (95% CI, 1.0-2.8). CONCLUSIONS: A waiting time of 12 weeks or more after waitlist enrollment for ESLD is associated with a modest likelihood of experiencing worse pain at 6 months postoperatively. This result was not because of differences in measured confounders. Future studies are encouraged to identify other, as-of-yet unmeasured, variables that might be associated with both longer waiting times and worse outcomes among ESLD patients. Until then, in jurisdictions where highly constrained access to ESLD is managed through waitlists, the expected waiting time for the operation could be an informative deciding criterion for patients with otherwise unresolved preferences for operative treatment.

Acute sciatica and progressive neurological deficit secondary to facet synovial cysts: A report of two cases.

OBJECTIVE: To describe two patients with lumbar facet synovial cysts causing sciatica and progressive neurological deficit. CLINICAL FEATURES: A 52-year-old female with bilateral sciatica and a neurological deficit that progressed to a foot drop; and a 54-year-old female with worsening sciatica and progressive calf weakness were seen at a major tertiary care centre. Diagnostic imaging studies revealed the presence of spinal nerve root impingement by large facet synovial cysts. INTERVENTIONS AND OUTCOMES: Activity modification, gabapentinoid and non-steroidal anti-inflammatory medications were unsuccessful in ameliorating either patient's symptoms. One patient had been receiving ongoing lumbar chiropractic spinal manipulative therapy despite the onset of a progressive neurological deficit. Both patients eventually required surgery to remove the cyst and decompress the affected spinal nerve roots. CONCLUSION: Patients with acute sciatica who develop a progressive neurological deficit while under care, require prompt referral for axial imaging and surgical consultation. Primary care spine clinicians need to be aware of lumbar facet synovial cysts as a possible cause of acute sciatica and the associated increased risk of the patient developing a progressive neurological deficit.

The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) study: a randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical low back pain.

BACKGROUND CONTEXT: Evidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear. PURPOSE: To determine if full CPGs-based study care (SC) results in greater improvement in functional outcomes than family physician-directed usual care (UC) in the treatment of AM-LBP. STUDY DESIGN/SETTING: A two-arm, parallel design, prospective, randomized controlled clinical trial using blinded outcome assessment. Treatment was administered in a hospital-based spine program outpatient clinic. PATIENT SAMPLE: Inclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks' duration. Exclusion criteria included "red flag" conditions and comorbidities contraindicating chiropractic spinal manipulative therapy (CSMT). PRIMARY OUTCOME: improvement from baseline in Roland-Morris Disability Questionnaire (RDQ) scores at 16 weeks. SECONDARY OUTCOMES: improvements in RDQ scores at 8 and 24 weeks; and in Short Form-36 (SF-36) bodily pain (BP) and physical functioning (PF) scale scores at 8, 16, and 24 weeks. METHODS: Patients were assessed by a spine physician, then randomized to SC (reassurance and avoidance of passive treatments, acetaminophen, 4 weeks of lumbar CSMT, and return to work within 8 weeks), or family physician-directed UC, the components of which were recorded. RESULTS: Ninety-two patients were recruited, with 36 SC and 35 UC patients completing all follow-up visits. Baseline prognostic variables were evenly distributed between groups. The primary outcome, the unadjusted mean improvement in RDQ scores, was significantly greater in the SC group than in the UC group (p=.003). Regarding unadjusted mean changes in secondary outcomes, improvements in RDQ scores were also greater in the SC group at other time points, particularly at 24 weeks (p=.004). Similarly, improvements in SF-36 PF scores favored the SC group at all time points; however, these differences were not statistically significant. Improvements in SF-36 BP scores were similar between groups. In repeated-measures analyses, global adjusted mean improvement was significantly greater in the SC group in terms of RDQ (p=.0002), nearly significantly greater in terms of SF-36 PF (p=.08), but similar between groups in terms of SF-36 BP (p=.27). CONCLUSIONS: This is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician-directed UC in the treatment of patients with AM-LBP. Compared to family physician-directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.

Magnetic resonance imaging and stadiometric assessment of the lumbar discs after sitting and chair-care decompression exercise: a pilot study.

BACKGROUND: Sitting is associated with loss of the lumbar lordosis, intervertebral disc (IVD) compression, and height loss, possibly increasing the risk of lower back pain. With a trend toward more sitting jobs worldwide, practical strategies for preventing lumbar flattening and potentially associated low back pain (LBP) are important. PURPOSE: The purpose of this study was to determine the feasibility of using upright magnetic resonance imaging (MRI) and stadiometry to measure changes in height and configuration of the lumbar spine before and after normal sitting and a seated unloading exercise intervention. STUDY DESIGN/SETTING: This is a hospital-based pilot study involving pre-post assessments in a single group. PATIENT SAMPLE: The sample comprises six asymptomatic hospital employees involved in either general patient care or research writing/data collection. OUTCOME MEASURES: The outcome measures were lumbar total midsagittal cross-sectional IVD area, vertical height, lordotic angle derived from digitized MRI examinations, and seated body height measured directly with a stadiometer. METHODS: Midsagittal MRI scans were performed before sitting, after 15 minutes of relaxed sitting ("postsitting"), immediately after seated unloading exercises, and approximately 7 minutes after exercise. Subsequently, seated stadiometry assessments were performed after 10 minutes of supine recumbency, 15 minutes of relaxed sitting, and every 10 seconds after seated unloading exercises until three consecutive height measurements were identical. Digitized midsagittal images were used to derive MRI-based outcome measures. Measurements at postsitting were compared with the corresponding ones at other time points using multiple paired t-tests. The Bonferroni method was used to adjust for multiple pairwise comparisons. MAIN RESULTS: After 15 minutes of sitting, mean total IVD area, lordotic angle, and vertical height of the lumbar spine decreased 18.6 mm(2), 6.2 degrees , and 12.5 mm, respectively, whereas after seated unloading exercises, these parameters increased by 87.9 mm(2), 5.0 degrees , and 21.9 mm, respectively. Similarly, mean seated height on stadiometry decreased by 6.9 mm after 15 minutes of sitting and subsequently increased by 5.7 mm after unloading exercises. CONCLUSIONS: Seated upright MRI and stadiometry, as performed in this study, appear to be feasible methods for detecting compressive and decompressive spinal changes associated with normal sitting and, alternately, seated unloading exercises. Larger studies are encouraged to determine normative values of our study measurements and to determine if morphological changes induced by seated unloading predict treatment response and/or reductions in the incidence of sitting-related LBP.

The effect of compensation status on waiting time for elective surgical lumbar discectomy.

STUDY DESIGN: Prospective cohort study of patients registered for elective surgical lumbar discectomy (ESLD) between November 1999 and December 2003 at a major tertiary care center in Vancouver. OBJECTIVE: To determine whether compensation status was associated with longer waiting time for ESLD. SUMMARY OF BACKGROUND DATA: In Canada, access to publicly funded ESLD is managed through waitlists. Patients are prioritized according to case severity and clinical need. However, it is not known whether compensation status is associated with waiting times. METHODS: Patients with sciatica from herniated lumbar disc, confirmed on advanced imaging, were registered for surgery. Information was collected on 393 patients, 66 (17%) who were receiving workers' compensation or personal disability insurance. Waiting time was calculated from registration to surgery and back pain and leg pain intensities were assessed by surgeons, using an 11-point numerical rating scale. Weekly probabilities of remaining on the waitlist were estimated using Kaplan-Meier methods. Patients undergoing emergency surgery or waiting longer than 12 months were censored. Waiting times were compared using the log-rank test, and Cox regression was used to estimate the effect of compensation on waiting after controlling for confounders. RESULTS: Pain intensity, neurologic status, and symptom duration were associated with waiting time. Compensation status was associated with a lower, statistically nonsignificant, likelihood of undergoing ESLD; hazard ratio (HR) = 0.83 (95% CI: 0.63-1.11) and the effect was attenuated with adjustment; HR = 1.02 (95% CI: 0.76-1.38). The median adjusted waiting time for surgery was 7 weeks among noncompensated and compensated patients. CONCLUSION: These results provide evidence that, contrary to conventional wisdom, compensation status was not associated with longer waits for ESLD. While patients receiving compensation have elsewhere been observed to have worse outcomes after discectomy, our results suggest this is unlikely to be due to delays imposed by queuing.

Willingness of emergency department patients with musculoskeletal complaints to participate in complementary and alternative medicine research.

BACKGROUND: The emergency department (ED) is a unique potential location for recruitment into studies of complementary and alternative medicine (CAM) therapies. We sought to determine the stated willingness of ED patients with musculoskeletal complaints to participate in CAM research for their presenting problem, and to determine the characteristics of this population. METHODS: The study was carried out in the ED of Vancouver General Hospital weekdays between 10 am and 6 pm from Oct. 16, 2000, to Nov. 21, 2000. All adults who presented with musculoskeletal complaints involving the spine, upper extremity or lower extremity, unless they had pain severe enough to impair their ability to answer questions or unless there was a language or other communication barrier, were approached by a research nurse. If it was learned that they had already been assessed by an emergency physician, they were eliminated as potential study participants. After being presented background information by the research nurse, consenting patients were asked a series of standardized questions during a 15-minute private interview prior to their assessment by an emergency physician. RESULTS: Of 107 eligible patients, 93 participated (87%). Most symptoms began on the day of presentation (44%) or in the previous week (41%). The mean age of those studied was 38 years, and 56% were male. Most presenting problems involved the ankle/foot (29%), multiple sites (19%), the lumbosacral region (14%) or the wrist/hand (14%). Seventy-six percent of patients had utilized CAM previously during their lives, and 13% were currently using CAM for their presenting problem. The majority of patients stated an informed hypothetical willingness to enroll in a CAM study of the following therapies: traditional Chinese medicine 74% (69/93: 95% confidence interval [CI] 64.1%-82.7%); chiropractic 70% (65/93: 95%CI 59.5%-79.0%); and other CAM therapies 92% (86/93: 95%CI 85.1%-96.9%). Of patients asked, 99% stated they would comply with 4 to 6 weeks of outpatient follow-up, and 70% stated they would participate in a placebo-controlled study. Logistic regression modeling, performed for secondary purposes, indicated that willingness to participate in traditional Chinese medicine or chiropractic research was independent of age, sex, educational status, pain severity or prior exposure to the modality of interest. CONCLUSIONS: ED patients with musculoskeletal complaints have a high stated willingness to participate in CAM research, even if this involves outpatient follow-up or a placebo-controlled design. ED-based CAM research appears feasible and should be pursued.