Exploring usual care for patients with low back pain in primary care: a cross-sectional study of general practitioners, physiotherapists and chiropractors.

OBJECTIVES: To explore the elements and composition of care provided by general practitioners (GPs), physiotherapists (PTs) and chiropractors (DCs) to patients with low back pain (LBP). DESIGN: Observational study. SETTING: Primary care setting, Denmark. PARTICIPANTS: Primary care clinicians (GPs, PTs and DCs) in the Region of Southern Denmark were invited to register consecutive adult patient visits with LBP as the primary complaint. PRIMARY OUTCOME MEASURES: Clinicians reported care elements provided to patients with LBP. Elements varied due to professional differences (eg, prescriptive rights). Data were descriptively analysed, on group and individual levels, for frequency and combination of care elements, and practice patterns were explored with latent class analysis. RESULTS: The clinicians (33 GPs, 67 PTs and 43 DCs with a median experience of 15 years and 59% were females) registered 3500 patient visits. On average, the visits involved patients aged 51 years, and 51% were with females. The frequencies of common care elements across professions were information (42%-56% of visits between professions) and advice (56%-81%), while other common elements for GPs were pain medication (40%) and referrals to PTs (36%), for PTs, use of exercises (81%) and for DCs, use of manual therapy (96%). Substantial variation was observed within professions and distinct practice patterns, with different focuses of attention to information and advice versus exercise and manual therapy, were identified for PTs and DCs. CONCLUSIONS: These data indicate substantial variation in the care elements provided by GPs, PTs and DCs to LBP patients. The compositions of care and practice patterns identified challenge the understanding of usual care as a uniform concept and professions as homogeneous groups. Strategic use of particular care elements in different parts of treatment courses is indicated. Longitudinal data and qualitative enquiry are needed to assess if or how care is tailored to individual patients.

Potential effect modifiers for treatment with chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years: development of and results from a secondary analysis of a randomised clinical trial.

BACKGROUND: A recent randomized controlled trial (RCT) investigating the effect of chiropractic manipulation in 199 children aged 7-14 years with recurrent headaches demonstrated a significant reduction of number of days with headache and a better global perceived effect (GPE) in the chiropractic manipulation group compared to a sham manipulation group. However, potential modifiers for the effectiveness of chiropractic manipulation of children with recurrent headaches have never been identified. The present study is a secondary analysis of data from that RCT and will investigate potential effect modifiers for the benefit of chiropractic manipulation for children with headache. METHODS: Sixteen potential effect modifiers were identified from the literature and a summary index was prespecified based on clinical experience. Relevant variables were extracted from baseline questionnaires, and outcomes were obtained by means of short text messages. The modifying effect of the candidate variables was assessed by fitting interaction models to the data of the RCT. In addition, an attempt to define a new summary index was made. RESULTS: The prespecified index showed no modifying effect. Four single variables demonstrated a treatment effect difference of more than 1 day with headache per week between the lower and the upper end of the spectrum: intensity of headache (p = 0.122), Frequency of headache (p = 0.031), sleep duration (p = 0.243), and Socioeconomic status (p = 0.082). Five variables had a treatment effect difference of more than 0.7 points on the GPE scale between the lower and the upper end of the spectrum: Frequency of headache (p = 0.056), Sport activity (p = 0.110), Sleep duration (p = 0.080), History of neck pain (p = 0.011), and Headache in the family (0.050). A new summary index could be constructed giving highest weight to History of neck pain and Headache in the family and Frequency of headache. The index suggests a difference of about 1 point in GPE between low and high values of the index. CONCLUSION: Chiropractic manipulation offers a moderate benefit for a broad spectrum of children. However, it cannot be excluded that specific headache characteristics, family factors, or a history of neck pain may modify the effect. This question must be addressed in future studies. TRIAL REGISTRATION: ClinicalTrials.gov (Albers et al in Curr Pain Headache Rep 19:3-4, 2015), identifier NCT02684916, registered 02/18/2016-retrospectively registered.

Description of recurrent headaches in 7-14-year-old children: Baseline data from a randomized clinical trial on effectiveness of chiropractic spinal manipulation in children with recurrent headaches.

BACKGROUND: Headaches in children are poorly described and diagnosing can be challenging. Objectives are: (1) to describe headache characteristics and child characteristics, (2) to explore whether data can suggest a more diverse way to categorize headaches than traditionally. METHODS: Baseline data for a clinical trial included a questionnaire and a physical screening. Children's characteristics and detailed description of headache symptoms were provided. Children were classified for migraine or tension-type-headache based on questionnaire data reported by children and parents. This required to apply slightly modified classification criteria and a "non-classifiable" group was added. Severity and symptoms, related to the migraine versus tension type distinction, were investigated to define a migraine-tension-type-index. RESULTS: 253 children were included. Mean pain intensity was 5.9/10. Over 2/3 of the children had headache for > 1 year, and > 50% for several days/week. Half of the children were non-classifiable, 22% were classified as migraine and 23% as tension-type headache. A migraine-tension-type-index was constructed and describes a continuous spectrum rather than two distinct groups. CONCLUSIONS: Children with recurrent headaches are often severely affected. A questionnaire-based classification appeared feasible to distinguish between migraine and tension-type headaches in children but leaving many children unclassified. A migraine-tension-type-index can be generated allowing to regard the traditional distinction as a continuum (including mixed headache), and potentially serving as an instrument to improve headache management. Trial registration ClinicalTrials.gov, identifier NCT02684916.

Assessing the effect of a regional integrated care model over ten years using quality indicators based on claims data - the basic statistical methodology of the INTEGRAL project.

BACKGROUND: The regional integrated health care model "Healthy Kinzigtal" started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. METHODS: This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. RESULTS: A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. CONCLUSIONS: We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.

Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial.

BACKGROUND: A recent trial identified large variation in effect of chiropractic care for infantile colic. Thus, identification of possible effect modifiers could potentially enhance the clinical reasoning to select infants with excessive crying for chiropractic care. Therefore, the aim of this study is to identify potential treatment effect modifiers which might influence the effect of chiropractic care for excessive crying in infancy. METHODS: Design: Prespecified secondary analyses of data from a randomised controlled trial. The analyses are partly confirmative and partly exploratory. SETTING: Four chiropractic clinics in Denmark. PARTICIPANTS: Infants aged 2-14 weeks with unexplained excessive crying. Of the 200 infants randomised (1:1), 103 were assigned to a chiropractic care group and 97 to a control group. INTERVENTION: Infants in the intervention group received chiropractic care for 2 weeks, while the control group was not treated. Main analyses: The outcome was change in daily hours of crying. Fifteen baseline variables and 6 general variables were selected as potential effect modifiers, and indices based on these were constructed. Factor analyses, latent class analyses and prognosis were used to construct other potentially modifying variables. Finally, an attempt at defining a new index aiming at optimal prediction of the treatment effect was made. The predictive value for all resulting variables were examined by considering the difference in mean change in crying time between the two treatment groups, stratified by the values of the candidate variables, i.e. interaction analyses. RESULTS: None of the predefined items or indices were shown to be useful in identifying colicky infants with potentially larger gain from manual therapy. However, more baseline hours of crying (p = 0.029), short duration of symptoms (p = 0.061) and young age (p = 0.089) were all associated with an increased effect on the outcome of hours of crying. CONCLUSION: Musculoskeletal indicators were not shown to be predictive of an increased benefit for colicky infants from chiropractic treatment. However, increased benefit was associated with early treatment and a high level of baseline crying, suggesting that the most severely affected infants have the greatest potential of benefiting from manual therapy. This finding requires validation by future studies. TRIAL REGISTRATION: Clinical Trials NCT02595515 , registered 2 November 2015.

Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years - a randomised clinical trial.

BACKGROUND: To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7-14 with recurrent headaches. METHODS: Design: A two-arm, single-blind, superiority randomised controlled trial. SETTING: One chiropractic clinic and one paediatric specialty practice in Denmark, November 2015 to August 2020. PARTICIPANTS: 199 children aged 7 to 14 years, with at least one episode of headache per week for the previous 6 months and at least one musculoskeletal dysfunction identified. INTERVENTIONS: All participants received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor's individual evaluation in the active treatment group; the children in the control group received approximately eight visits during the treatment period. PRIMARY OUTCOME MEASURES: 'Number of days with headache', 'pain intensity' and 'medication' were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. 'Number of days with headache' and 'pain intensity' were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. RESULTS: Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p = 0.019, NNT = 7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR = 2.8 (95% CI: 1.5-5.3), NNT = 5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. CONCLUSIONS: Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT02684916 , registered 02/18/2016 - retrospectively registered.

Baseline Characteristics May Help Indicate the Best Choice of Health Care Provider for Back Pain Patients in Primary Care: Results From a Prospective Cohort Study.

OBJECTIVE: Baseline characteristics of patients low back pain differ substantially between care settings, but it is largely unknown whether predictors are of equal importance across settings. The aim of this study was to investigate whether 8 known predictors relate differently to outcomes in chiropractic practice and in general practice and to which degree these factors may be helpful in selecting patients benefiting more from one setting or the other. METHODS: Patient characteristics were collected at baseline, and outcomes of pain intensity (numeric rating scale 0-10) and activity limitation (Roland-Morris Disability Questionnaire 0-100) after 2, 12, and 52 weeks. Differences in the prognostic strength between settings were investigated for each prognostic factor separately by estimating the interaction between setting and the prognostic factor using regression models. Between-setting differences in outcome in high-risk and low-risk subgroups, formed by single prognostic factors, were assessed in similar models adjusted for a propensity score to take baseline differences between settings into account. RESULTS: Prognostic factors were generally associated more strongly with outcomes in general practice compared with chiropractic practice. The difference was statistically significant for general health, duration of pain, and musculoskeletal comorbidity. After propensity score adjustment, differences in outcomes between settings were insignificant, but negative prognostic factors tended to be less influential in chiropractic practice except for leg pain and depression, which tended to have less negative impact in general practice. CONCLUSION: Known prognostic factors related differently to outcomes in the 2 settings, suggesting that some subgroups of patients might benefit more from one setting than the other.

Effectiveness of chiropractic manipulation versus sham manipulation on recurrent headaches in children aged 7-14 years, Protocol for a randomized clinical trial.

Background: Headache is one of the most common pain symptoms in childhood having a negative impact on many aspects of the lives of affected children, both short-term and long-term. Therefore, it is important to document safe and effective treatment options. Chiropractic spinal manipulation is a commonly used treatment option for these patients, although there are no randomized clinical trials documenting the effectiveness of this in pediatric headache. However, there is moderate evidence for effectiveness of spinal manipulation for adults with tension-type and cervicogenic headaches.This paper describes the protocol for a two-armed randomized superiority clinical trial aiming to investigate the effectiveness of chiropractic manipulation versus sham manipulation in the treatment of recurrent headache in children aged 7-14. Methods: Children with weekly headaches for at least six months will be included if they have indications for chiropractic manipulation. The participants will be randomized to either chiropractic manipulation or sham manipulation. Both children and parents will be blinded for allocation. There will be 100 children in each arm and they will answer weekly text messages four weeks prior to treatment and during a four months treatment period. Potential primary outcomes are weekly number of headaches, intensity of headache, medication use and global perceived effect. Secondary outcomes include side-effects and headache status after one year.An initial outcome data analysis will be performed to inform the choice of primary outcome (adaptive design). Intervention effects will be reported as the difference in mean values between the two treatment arms, Cohen's effect size and numbers needed to treat. Discussion: A major strength of this study is its pragmatic nature, where the active treatment group receives chiropractic manipulation according to their individual needs, while both groups continue their use of medication for headache according to their pre-trial habits. Other strengths include an elaborate sham procedure and the weekly outcome reports, reducing recall bias.If it is possible to develop effective treatment for headache in children, a life course of recurring problems may be altered with potential positive implications for both individuals and society. Trial registration: ClinicalTrials.gov, identifier NCT02684916.

GLA:D® Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study.

BACKGROUND: Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel. METHODS: The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. DISCUSSION: This implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

Study protocol for a quasi-experimental claims-based study evaluating 10-year results of the population-based integrated healthcare model 'Gesundes Kinzigtal' (Healthy Kinzigtal): the INTEGRAL study.

INTRODUCTION: Patients often experience interface problems when treated by different specialists and in different healthcare sectors. Integrated care concepts aim to reduce these problems. While most integrated healthcare models focus on individual diseases, the integrated care model 'Gesundes Kinzigtal' applies a population-based approach and addresses the full spectrum of morbidities for a population defined by area of residence-the Kinzigtal. A special feature of the model is the joint savings contract between the regional management company and the statutory health insurers. The INTEGRAL study aims at assessing the effectiveness of 'Gesundes Kinzigtal' under routine conditions in comparison to conventional care over a period of 10 years in order to understand the benefits but also the potential for (unintended) harms. METHODS AND ANALYSIS: Database Claims data from statutory health insurance funds 2005-2015. The evaluation consists of a quasi-experimental study, with Kinzigtal as intervention region, at least 10 further regions with a similar population and healthcare infrastructure as primary controls and an additional random sample of insurees from the federal state of Baden-Württemberg as secondary controls. Model-specific and 'non-specific' indicators adopted from the literature and enriched by focus group interviews will be used to evaluate the model's effectiveness and potential unintended consequences by analysing healthcare utilisation in general. Temporal trends per indicator in the intervention region will be compared with those in each control region. The overall variation in trends for the indicators across all regions provides information about the potential to modify an indicator due to local differences in the healthcare system. ETHICS AND DISSEMINATION: Ethic Commission of the Faculty of Medicine, Philipps-University Marburg (ek_mr_geraedts_131117). Results will be discussed in workshops, submitted for publication in peer-review journals and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00012804.

Does a Diagnostic Classification Algorithm Help to Predict the Course of Low Back Pain? A Study of Danish Chiropractic Patients With 1-Year Follow-up.

BACKGROUND: A diagnostic classification algorithm, "the Petersen classification," consisting of 12 categories based on a standardized examination protocol, was developed for the primary purpose of identifying clinically homogeneous subgroups of individuals with low back pain (LBP). OBJECTIVES: To investigate whether a diagnostic classification algorithm is associated with activity limitation and LBP intensity at follow-up assessments of 2 weeks, 3 months, and 1 year, and whether the algorithm improves outcome prediction when added to a set of known predictors. METHODS: This was a prospective observational study of 934 consecutive adult patients with new episodes of LBP who were visiting chiropractic practices in primary care and categorized according to the Petersen classification. Outcomes were disability and pain intensity measured with questionnaires at 2 weeks and 3 months, and 1-year trajectories of LBP based on weekly responses to text messages. Associations were analyzed with linear and logistic regression models. In a subgroup of patients, the numbers of visits to primary and secondary care were described. RESULTS: The Petersen classification was statistically significantly associated with all outcomes (P<.001) but explained very little of the variance (R2 = 0.00-0.05). Patients in the nerve root involvement category had the most pain and activity limitation and the most visits to primary and secondary care. Patients in the myofascial pain category were the least affected. CONCLUSION: The Petersen classification was not helpful in determining individual prognosis in patients with LBP receiving usual care in chiropractic practice. However, patients should be examined for potential nerve root involvement to improve prediction of likely outcomes. LEVEL OF EVIDENCE: Prognosis, level 1b. J Orthop Sports Phys Ther 2018;48(11):837-846. Epub 8 May 2018. doi:10.2519/jospt.2018.8083.

4000 years of human dietary evolution in central Germany, from the first farmers to the first elites.

Investigation of human diet during the Neolithic has often been limited to a few archaeological cultures or single sites. In order to provide insight into the development of human food consumption and husbandry strategies, our study explores bone collagen carbon and nitrogen isotope data from 466 human and 105 faunal individuals from 26 sites in central Germany. It is the most extensive data set to date from an enclosed geographic microregion, covering 4,000 years of agricultural history from the Early Neolithic to the Early Bronze Age. The animal data show that a variety of pastures and dietary resources were explored, but that these changed remarkably little over time. In the human δ15N however we found a significant increase with time across the different archaeological cultures. This trend could be observed in all time periods and archaeological cultures (Bell Beaker phenomenon excluded), even on continuously populated sites. Since there was no such trend in faunal isotope values, we were able largely to exclude manuring as the cause of this effect. Based on the rich interdisciplinary data from this region and archaeological period we can argue that meat consumption increased with the increasing duration of farming subsistence. In δ13C, we could not observe any clear increasing or decreasing trends during the archaeological time periods, either for humans or for animals, which would have suggested significant changes in the environment and landscape use. We discovered sex-related dietary differences, with males of all archaeological periods having higher δ15N values than females, and an age-related increasing consumption of animal protein. An initial decrease of δ15N-values at the age of 1-2 years reveals partial weaning, while complete weaning took place at the age of 3-4 years.

Leg pain location and neurological signs relate to outcomes in primary care patients with low back pain.

BACKGROUND: Low back pain (LBP) patients with related leg pain and signs of nerve root involvement are considered to have a worse prognosis than patients with LBP alone. However, it is unclear whether leg pain location above or below the knee and the presence of neurological signs are important in primary care patients. The objectives of this study were to explore whether the four Quebec Task Force categories (QTFC) based on the location of pain and on neurological signs have different characteristics at the time of care seeking, whether these QTFC are associated with outcome, and if so whether there is an obvious ranking of the four QTFC on the severity of outcomes. METHOD: Adult patients seeking care for LBP in chiropractic or general practice were classified into the four QTFC based on self-reported information and clinical findings. Analyses were performed to test the associations between the QTFC and baseline characteristics as well as the outcomes global perceived effect and activity limitation after 2 weeks, 3 months, and 1 year and also 1-year trajectories of LBP intensity. RESULTS: The study comprised 1271 patients; 947 from chiropractic practice and 324 from general practice. The QTFC at presentation were statistically significantly associated with most of the baseline characteristics, with activity limitation at all follow-up time points, with global perceived effect at 2 weeks but not 3 months and 1 year, and with trajectories of LBP. Severity of outcomes in the QTFC increased from LBP alone, across LBP with leg pain above the knee and below the knee to LBP with nerve root involvement. However, the variation within the categories was considerable. CONCLUSION: The QTFC identify different LBP subgroups at baseline and there is a consistent ranking of the four categories with respect to outcomes. The differences between outcomes appear to be large enough for the QTFC to be useful for clinicians in the communication with patients. However, due to variation of outcomes within each category individuals' outcome cannot be precisely predicted from the QTFC alone. It warrants further investigation to find out if the QTFC can improve existing prediction tools and guide treatment decisions.

Cost-effectiveness of chiropractic care versus self-management in patients with musculoskeletal chest pain.

AIMS: To assess whether primary sector healthcare in the form of chiropractic care is cost-effective compared with self-management in patients with musculoskeletal chest pain, that is, a subgroup of patients with non-specific chest pain. METHODS AND RESULTS: 115 adults aged 18-75 years with acute, non-specific chest pain of musculoskeletal origin were recruited from a cardiology department in Denmark. After ruling out acute coronary syndrome and receiving usual care, patients with musculoskeletal chest pain were randomised to 4 weeks of community-based chiropractic care (n=59) or to a single information session aimed at encouraging self-management as complementary to usual care (n=56). Data on resource use were obtained from Danish national registries and valued from a societal perspective. Patient cost and health-related quality-adjusted life years (QALYs; based on EuroQol five-dimension questionnaire (EQ-5D) and Short Form 36-item Health Survey (SF-36)) were compared in cost-effectiveness analyses over 12 months from baseline. Mean costs were €2183 lower for the group with chiropractic care, but not statistically significant (95% CI -4410.5 to 43.0). The incremental cost-effectiveness ratio suggested that chiropractic care was cost-effective with a probability of 97%, given a threshold value of €30 000 per QALY gained. In both groups, there was an increase in the health-related quality of life, and the mean increases were similar over the 12-month evaluation period. The mean differences in QALYs between the groups were negligible. CONCLUSIONS: Chiropractic care was more cost-effective than self-management. Therefore, chiropractic care can be seen as a good example of a targeted primary care approach for a subgroup of patients with non-specific chest pain. TRIAL REGISTRATION NUMBER: NCT00462241.

Expectation of recovery from low back pain: a longitudinal cohort study investigating patient characteristics related to expectations and the association between expectations and 3-month outcome.

STUDY DESIGN: A prospective cohort study conducted in general practice (GP) and chiropractic practice (CP). OBJECTIVE: To explore which patient characteristics were associated with recovery expectations in patients with low back pain (LBP), whether expectations predicted 3-month outcome, and to what extent expectations were associated with empirical prognostic factors. SUMMARY OF BACKGROUND DATA: Patients' recovery expectations have been associated with prognosis, but it is largely unknown why patients expect what they do, and how expectations relate to other prognostic factors. METHODS: A total of 1169 participants completed questionnaires at their first consultation due to LBP, and 78% were followed for 3 months. At baseline, recovery expectations were measured on a 0 to 10 scale. Outcome measures were LBP intensity and global perceived effect. Associations were tested in regression models, and the predictive capacity of expectations described in terms of adjusted R and area under the receiver operating characteristic curve. Correlations between predicted expectations and prognosis were quantified by the Spearman rho. RESULTS: Expectations were associated with known prognostic factors, mainly LBP history, but were only partly explained by measured factors (adjusted R, 35% [CP]/55% [GP]). Expectations had statistically significant associations with both outcomes after adjusting for other baseline factors, but explained only a little of the variance in LBP (adjusted R: 0.11 CP/0.32 GP) and did not add to the explained variance. The prediction of global perceived effect was limited in CP (area under the receiver operating characteristics curve, 0.59), but more substantial in GP (area under the receiver operating characteristics curve, 0.77) patients. Correlations between predicted expectations and predicted outcome were strong. CONCLUSION: Patients' recovery expectations were associated mainly with LBP history and were generally, but not consistently, similar to an empirically predicted prognosis. Expectations were significantly associated with outcome, and may, at least for some outcomes, be a relevant proxy for more complex models. Future studies should explore the effect of addressing negative recovery expectations. LEVEL OF EVIDENCE: 2.

Reproducibility of range of motion and muscle strength measurements in patients with hip osteoarthritis - an inter-rater study.

BACKGROUND: Assessment of range of motion (ROM) and muscle strength is fundamental in the clinical diagnosis of hip osteoarthritis (OA) but reproducibility of these measurements has mostly involved clinicians from secondary care and has rarely reported agreement parameters. Therefore, the primary objective of the study was to determine the inter-rater reproducibility of ROM and muscle strength measurements. Furthermore, the reliability of the overall assessment of clinical hip OA was evaluated. Reporting is in accordance with proposed guidelines for the reporting of reliability and agreement studies (GRRAS). METHODS: In a university hospital, four blinded raters independently examined patients with unilateral hip OA; two hospital orthopaedists independently examined 48 (24 men) patients and two primary care chiropractors examined 61 patients (29 men). ROM was measured in degrees (deg.) with a standard two-arm goniometer and muscle strength in Newton (N) using a hand-held dynamometer. Reproducibility is reported as agreement and reliability between paired raters of the same profession. Agreement is reported as limits of agreement (LoA) and reliability is reported with intraclass correlation coefficients (ICC). Reliability of the overall assessment of clinical OA is reported as weighted kappa. RESULTS: Between orthopaedists, agreement for ROM ranged from LoA [-28-12 deg.] for internal rotation to [-8-13 deg.] for extension. ICC ranged between 0.53 and 0.73, highest for flexion. For muscle strength between orthopaedists, LoA ranged from [-65-47N] for external rotation to [-10 -59N] for flexion. ICC ranged between 0.52 and 0.85, highest for abduction. Between chiropractors, agreement for ROM ranged from LoA [-25-30 deg.] for internal rotation to [-13-21 deg.] for flexion. ICC ranged between 0.14 and 0.79, highest for flexion. For muscle strength between chiropractors, LoA ranged between [-80-20N] for external rotation to [-146-55N] for abduction. ICC ranged between 0.38 and 0.81, highest for flexion. Weighted kappa for the overall assessment of clinical hip OA was 0.52 between orthopaedists and 0.65 between chiropractors. CONCLUSIONS: Reproducibility of goniometric and dynamometric measurements of ROM and muscle strength in patients with hip OA is poor between experienced orthopaedists and between experienced chiropractors. Orthopaedists and chiropractors can to a moderate degree differentiate between hips with or without osteoarthritis.

A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain: 1-year follow-up.

OBJECTIVE: We have previously reported short-term follow-up from a pragmatic randomized clinical trial comparing 2 treatments for acute musculoskeletal chest pain: (1) chiropractic treatment and (2) self-management. Results indicated a positive effect in favor of the chiropractic treatment after 4 and 12 weeks. The current article investigates the hypothesis that the advantage observed at 4 and 12 weeks would be sustained after 1 year. In addition, we describe self-reported consequences of acute musculoskeletal chest pain at 1-year follow-up. METHODS: In a nonblinded, randomized controlled trial undertaken at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain of musculoskeletal origin were included. After the baseline evaluation, patients were randomized to 4 weeks of either chiropractic treatment or self-management, with posttreatment questionnaire follow-up 52 weeks later. The primary outcome measures were change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). RESULTS: Both groups experienced decreases in pain, positive global, self-perceived treatment effect, and increases in the 36-Item Short Form Health Survey scores. No statistically significant differences were observed between groups at the 1-year follow-up, and we could not deduce a common trend in favor of either intervention. CONCLUSIONS: At the 1-year follow-up, we found no difference between groups in terms of pain intensity and self-perceived change in chest pain in the first randomized clinical trial assessing chiropractic treatment vs minimal intervention for patients with acute musculoskeletal chest pain. Further research into health care utilization and use of prescriptive medication is warranted.

Reconstruction of the decision-making process in assessing musculoskeletal chest pain: an exploratory study using recursive partitioning.

OBJECTIVE: The purposes of this study were to identify the most important determinants from the patient history and clinical examination in diagnosing musculoskeletal chest pain (MSCP) in patients with acute noncardiac chest pain when supported by a structured protocol and to construct a decision tree for identification of MSCP in acute noncardiac chest pain. METHODS: Consecutive patients with noncardiac chest pain (n = 302) recruited from an emergency cardiology department were assessed. Using data from self-report questionnaires, interviews, and clinical assessment, patient characteristics were associated with the MSCP diagnosis, and the decision-making process of the clinician was reconstructed using recursive procedures in the tradition of constructing Classification and Regression Trees. RESULTS: Thirty-eight percent of patients had MSCP. There was no single determinant that predicted the condition completely. However, many items with high associations could be identified, mainly with high negative predictive value. The decision-making process was reconstructed giving rise to a 5-step, linear decision tree without branches. CONCLUSIONS: Clinicians use a combination of indicators including systematic palpation of the spine and chest wall and items from the case history to diagnose MSCP. However, the high negative predictive values of the main determinants suggest that the MSCP diagnosis may be a diagnosis by exclusion.

Chiropractic treatment vs self-management in patients with acute chest pain: a randomized controlled trial of patients without acute coronary syndrome.

OBJECTIVE: The musculoskeletal system is a common but often overlooked cause of chest pain. The purpose of the present study is to evaluate the relative effectiveness of 2 treatment approaches for acute musculoskeletal chest pain: (1) chiropractic treatment that included spinal manipulation and (2) self-management as an example of minimal intervention. METHODS: In a nonblinded, randomized, controlled trial set at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to 4 weeks of chiropractic treatment or self-management, with posttreatment questionnaire follow-up 4 and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). RESULTS: Both groups experienced decreases in pain, self-perceived positive changes, and increases in Medical Outcomes Study Short Form 36-Item Health Survey scores. Observed between-group significant differences were in favor of chiropractic treatment at 4 weeks regarding the primary outcome of self-perceived change in chest pain and at 12 weeks with respect to the primary outcome of numeric change in pain intensity. CONCLUSIONS: To the best of our knowledge, this is the first randomized trial assessing chiropractic treatment vs minimal intervention in patients without acute coronary syndrome but with musculoskeletal chest pain. Results suggest that chiropractic treatment might be useful; but further research in relation to patient selection, standardization of interventions, and identification of potentially active ingredients is needed.