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BACKGROUND: Persistent pain is a frequent cause of sick leave and work disability in Norway. A return-to-work intervention featuring supported work placements, developed in the UK, demonstrated feasibility, and a return-to-work rate of 20% within 6 months was observed in the sample. We sought to adapt the intervention for delivery in Norway and to confirm feasibility prior to a full-scale trial. METHODS: In this internal pilot, we used a pragmatic cohort randomised controlled approach with national recruitment in Norway. We recruited people who were unemployed (for at least 1 month), having persistent pain (for at least 3 months), aged between 18 and 64, and wanting to return to work. We initially recruited people to an observational cohort study of the impact of being unemployed with persistent pain. After baseline measurement, we randomly sub-sampled participants to whom we offered the intervention, which featured individual case management and support, work-familiarisation sessions, and the offer of a 6-week part-time unpaid work placement. We assessed recruitment rates (aiming to recruit 66, and sub-sample 17 within 6 months); optimal recruitment pathways; intervention acceptance rates; the feasibility of data collection; using video links for work-familiarisation sessions and remote case manager support. RESULTS: The pilot ran from June to November 2022. Of 168 people expressing interest, 94 consented. Recruitment posts on Facebook yielded the most 'expressions of interest' (66%, n = 111). After screening for eligibility, we included 55 participants. Of these, 19 were randomised to be offered the intervention. Of these, less than half (n = 8) consented to intervention participation. Remote case manager and work-familiarisation sessions appeared feasible. Following a delay in identifying placements, three participants received offers of work placements, with one starting and completing during the pilot period. Data collection methods were feasible, and no adverse events were reported. CONCLUSIONS: Recruitment and logistical processes, such as remote management by video link, are feasible. However, delivery of the intervention is challenging. In particular, sourcing placements and the time required for identifying appropriate placements was more challenging than anticipated. A full-scale trial is feasible but will require improvements to the placement identification processes. TRIAL REGISTRATION: ISRCTN85437524 (Referring to the ReISE trial, of which this internal pilot was a part), Registered 31 of May 2022 https://doi.org/10.1186/ISRCTN85437524 TRIAL FUNDING: Norwegian Research Council.
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BACKGROUND: To describe the frequency of primary care seeking for neck or back-related conditions among people with chronic neck and low back pain and to develop prediction models of primary care seeking and frequent visits. METHODS: We included participants of the Trøndelag Health Study (HUNT4, 2017-19) in Norway who self-reported chronic neck and/or low back pain in the preceding year, and extracted data of primary care visits from the Norwegian primary healthcare registry. We investigated a total of 23 potential predictors and used multivariable logistic regression models to predict primary care seeking for neck or back-related conditions and frequent visits by healthcare provider (i.e., the highest quartile of number of visits). RESULTS: Among the 15,352 HUNT4 participants with chronic neck and/or low back pain, 6231 participants (40.6%) sought primary care for neck or back-related conditions (median = 5 visits, IQR 2-15) within 2 years after the study. Participants who consulted physical therapists sought care the most frequently (median = 10 visits, IQR 3-26). Discrimination of the best-fit prediction model of primary care seeking and frequent visits by healthcare provider, assessed by C-statistic, ranged from 0.66-0.76. Participants who made frequent primary care visits in the preceding year were highly likely to continue frequent care seeking in the following 2 years. CONCLUSIONS: Around 40% of people seek primary care for chronic neck and low back pain, and frequent care seeking may continue for years. Future studies should investigate strategies to reduce recurrent primary care visits, especially seeking physical therapist care, and promote self-management of chronic pain. SIGNIFICANCE: People with chronic neck and low back pain who seek physical therapist care had the highest frequency of care seeking, underscoring the significant burden on healthcare systems. The high frequency of visits and associated healthcare expenditures highlight the critical need for effective and valuable primary care for chronic pain management. To mitigate recurrent visits and reduce costs, it is essential to provide patients with evidence-based treatments and self-management interventions.
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This metaresearch study aimed to evaluate the completeness of reporting of prediction model studies in patients with spinal pain or osteoarthritis (OA) in terms of adherence to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) statement. We searched for prognostic and diagnostic prediction models in patients with spinal pain or OA in MEDLINE, Embase, Web of Science, and CINAHL. Using a standardized assessment form, we assessed the adherence to the TRIPOD of the included studies. Two independent reviewers performed the study selection and data extraction phases. We included 66 studies. Approximately 35% of the studies declared to have used the TRIPOD. The median adherence to the TRIPOD was 59% overall (interquartile range (IQR): 21.8), with the items of the methods and results sections having the worst reporting. Studies on neck pain had better adherence to the TRIPOD than studies on back pain and OA (medians of 76.5%, 59%, and 53%, respectively). External validation studies had the highest total adherence (median: 79.5%, IQR: 12.8) of all the study types. The median overall adherence was 4 points higher in studies that declared TRIPOD use than those that did not. Finally, we did not observe any improvement in adherence over the years. The adherence to the TRIPOD of prediction models in the spinal and OA fields is low, with the methods and results sections being the most poorly reported. Future studies on prediction models in spinal pain and OA should follow the TRIPOD to improve their reporting completeness. PERSPECTIVE: This article provides data about adherence to the TRIPOD statement in 66 prediction model studies for spinal pain or OA. The adherence to the TRIPOD statement was found to be low (median adherence of 59%). This inadequate reporting may negatively impact the effective use of the models in clinical practice.
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BACKGROUND: The predictive validity of the STarT Back screening tool among older adults is uncertain. This study aimed to assess the predictive validity of the SBT among older adults in primary care. METHODS: This prospective cohort study included 452 patients aged ≥55 years seeking Norwegian primary care with a new episode of back pain. A poor outcome (persistent disabling back pain) was defined as a score of ≥7/24 on the Roland-Morris Disability Questionnaire (RMDQ) at 3, 6 or 12 months of follow-up. The ability of the SBT risk groups to identify persistent disabling back pain was assessed with multivariable logistic regression, area under receiver operating characteristics curve (AUC), and with the accuracy measures sensitivity, specificity, predictive values and likelihood ratios. RESULTS: The adjusted odds ratios (95% CI) for persistent disabling back pain were 2.40 (1.34-4.30) at 3 months, 3.42 (1.76-6.67) at 6 months and 2.81 (1.47-5.38) at 12 months for the medium-risk group (n = 118), and 8.90 (1.83-43.24), 2.66 (0.81-8.67) and 4.53 (1.24-16.46) for the high-risk group (n = 27), compared to the low-risk group (n = 282). There were no statistically significant differences in odds between the medium- and high-risk groups at any time point. AUC values (95% CI) were 0.65 (0.59-0.71), 0.67 (0.60-0.73) and 0.65 (0.58-0.71) at 3, 6 and 12 months. Accuracy measures were poor at all time points, with particularly poor sensitivity and negative likelihood ratio values. CONCLUSION: The predictive validity of the SBT risk groups in predicting persistent disabling back pain in older adults was poor. SIGNIFICANCE STATEMENT: This study found that the STarT Back screening tool had poor predictive validity among older adults and that it may need recalibration or extension before widespread implementation among older adults. Having valid tools for this population may aid clinicians with allocating scarce healthcare resources, which is especially important considering the rapidly ageing population and its expected challenge to the healthcare systems.
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Investigating how individual characteristics modify treatment effects can improve understanding, interpretation, and translation of trial findings. The purpose of this secondary analysis was to identify treatment effect modifiers of the MI-NAV trial, a 3 arm, parallel randomized controlled trial which compared motivational interviewing and stratified vocational advice intervention in addition to usual case management (UC), to UC alone. This study included (n = 514) participants with musculoskeletal disorders on sick leave for at least 50% of their contracted work hours for at least 7 consecutive weeks with the Norwegian Labour and Welfare Administration. Sickness absence days was the primary outcome, measured from baseline assessment date until the 6-month follow-up. Potential treatment effect modifiers, identified a priori and informed by expert consultation and literature, were evaluated using linear regression models and statistical interaction tests. For motivational interviewing versus UC, age (mean difference [MD] -.7, 95% confidence interval [CI] -1.5 to .2; P = .13) and self-perceived health status (MD -.3, 95% CI -.7 to .1; P = .19) were identified as potential effect modifiers (P ≤ .2). For stratified vocational advice intervention versus UC, analgesic medication use (MD -26.2, 95% CI -45.7 to -6.7; P = .009) was identified as a treatment effect modifier (P ≤ .05). These findings may assist in more targeted treatment adaptation and translation as well as the planning of future clinical trials. PERSPECTIVE: This secondary analysis of the MI-NAV trial found that analgesic medication use, age, and self-perceived health may modify the effect of 2 vocational interventions on reducing sickness absence in people with musculoskeletal disorders.
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OBJECTIVES: To evaluate the 1-year cost-effectiveness of strength exercise or aerobic exercise compared with usual care for patients with symptomatic knee osteoarthritis (OA), from a societal and healthcare perspective. DESIGN: Cost-effectiveness analysis embedded in a three-arm randomised controlled trial. PARTICIPANTS AND SETTING: A total of 161 people with symptomatic knee OA seeking Norwegian primary or secondary care were included in the analyses. INTERVENTIONS: Participants were randomised to either 12 weeks of strength exercise (n=54), 12 weeks of aerobic exercise (n=53) or usual care (n=54). OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated by the EuroQol-5 Dimensions-5 Levels, and costs related to healthcare utilisation and productivity loss estimated in euros (), aggregated for 1 year of follow-up. Cost-effectiveness was expressed with mean incremental cost-effectiveness ratios (ICERs). Bootstrapping was used to estimate ICER uncertainty. RESULTS: From a 1-year societal perspective, the mean cost per patient was 7954, 8101 and 17 398 in the strength exercise, aerobic exercise and usual care group, respectively. From a 1-year healthcare perspective, the mean cost per patient was 848, 2003 and 1654 in the strength exercise, aerobic exercise and usual care group, respectively. Mean differences in costs significantly favoured strength exercise and aerobic exercise from a 1-year societal perspective and strength exercise from a 1-year healthcare perspective. There were no significant differences in mean QALYs between groups. From a 1-year societal perspective, at a willingness-to-pay threshold of 27 500, the probability of strength exercise or aerobic exercise being cost-effective was ≥98%. From a 1-year healthcare perspective, the probability of strength exercise or aerobic exercise being cost-effective was ≥97% and ≥76%, respectively. CONCLUSION: From a 1-year societal and healthcare perspective, a 12-week strength exercise or aerobic exercise programme is cost-effective compared with usual care in patients with symptomatic knee OA. TRIAL REGISTRATION NUMBER: NCT01682980.
Subject(s)
Cost-Benefit Analysis , Exercise Therapy , Osteoarthritis, Knee , Quality-Adjusted Life Years , Resistance Training , Humans , Osteoarthritis, Knee/therapy , Osteoarthritis, Knee/economics , Male , Female , Norway , Middle Aged , Aged , Exercise Therapy/economics , Exercise Therapy/methods , Resistance Training/economics , Resistance Training/methods , Exercise , Health Care Costs/statistics & numerical dataABSTRACT
BACKGROUND: Spinal disorders are highly prevalent worldwide with high socioeconomic costs. This cost is associated with the demand for treatment and productivity loss, prompting the exploration of technologies to improve patient outcomes. Clinical decision support systems (CDSSs) are computerized systems that are increasingly used to facilitate safe and efficient health care. Their applications range in depth and can be found across health care specialties. OBJECTIVE: This scoping review aims to explore the use of CDSSs in patients with spinal disorders. METHODS: We used the Joanna Briggs Institute methodological guidance for this scoping review and reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) statement. Databases, including PubMed, Embase, Cochrane, CINAHL, Web of Science, Scopus, ProQuest, and PsycINFO, were searched from inception until October 11, 2022. The included studies examined the use of digitalized CDSSs in patients with spinal disorders. RESULTS: A total of 4 major CDSS functions were identified from 31 studies: preventing unnecessary imaging (n=8, 26%), aiding diagnosis (n=6, 19%), aiding prognosis (n=11, 35%), and recommending treatment options (n=6, 20%). Most studies used the knowledge-based system. Logistic regression was the most commonly used method, followed by decision tree algorithms. The use of CDSSs to aid in the management of spinal disorders was generally accepted over the threat to physicians' clinical decision-making autonomy. CONCLUSIONS: Although the effectiveness was frequently evaluated by examining the agreement between the decisions made by the CDSSs and the health care providers, comparing the CDSS recommendations with actual clinical outcomes would be preferable. In addition, future studies on CDSS development should focus on system integration, considering end user's needs and preferences, and external validation and impact studies to assess effectiveness and generalizability. TRIAL REGISTRATION: OSF Registries osf.io/dyz3f; https://osf.io/dyz3f.
Subject(s)
Decision Support Systems, Clinical , Humans , Algorithms , Clinical Decision-Making , Databases, FactualABSTRACT
OBJECTIVES: The objective was to identify modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders, and to identify modifiable prognostic factors of high costs related to separately healthcare utilisation and productivity loss. DESIGN: A prospective cohort study with a 1-year follow-up. PARTICIPANTS AND SETTING: A total of 549 participants (aged 18-67 years) on sick leave (≥ 4 weeks) due to musculoskeletal disorders in Norway were included. OUTCOME MEASURES AND METHOD: The primary outcome was societal costs aggregated for 1 year of follow-up and dichotomised as high or low, defined by the top 25th percentile. Secondary outcomes were high costs related to separately healthcare utilisation and productivity loss aggregated for 1 year of follow-up. Healthcare utilisation was collected from public records and included primary, secondary and tertiary healthcare use. Productivity loss was collected from public records and included absenteeism, work assessment allowance and disability pension. Nine modifiable prognostic factors were selected based on previous literature. Univariable and multivariable binary logistic regression analyses were performed to identify associations (crude and adjusted for selected covariates) between each modifiable prognostic factor and having high costs. RESULTS: Adjusted for selected covariates, six modifiable prognostic factors associated with high societal costs were identified: pain severity, disability, self-perceived health, sleep quality, return to work expectation and long-lasting disorder expectation. Depressive symptoms, work satisfaction and health literacy showed no prognostic value. More or less similar results were observed when high costs were related to separately healthcare utilisation and productivity loss. CONCLUSION: Factors identified in this study are potential target areas for interventions which could reduce high societal costs among people on sick leave due to musculoskeletal disorders. However, future research aimed at replicating these findings is warranted. TRIAL REGISTRATION NUMBER: NCT04196634, 12 December 2019.
Subject(s)
Musculoskeletal Diseases , Sick Leave , Humans , Cohort Studies , Prospective Studies , PrognosisABSTRACT
[This corrects the article DOI: 10.1371/journal.pone.0264954.].
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Importance: Lumber disc herniation surgery can reduce pain and disability. However, a sizable minority of individuals experience minimal benefit, necessitating the development of accurate prediction models. Objective: To develop and validate prediction models for disability and pain 12 months after lumbar disc herniation surgery. Design, Setting, and Participants: A prospective, multicenter, registry-based prognostic study was conducted on a cohort of individuals undergoing lumbar disc herniation surgery from January 1, 2007, to May 31, 2021. Patients in the Norwegian Registry for Spine Surgery from all public and private hospitals in Norway performing spine surgery were included. Data analysis was performed from January to June 2023. Exposures: Microdiscectomy or open discectomy. Main Outcomes and Measures: Treatment success at 12 months, defined as improvement in Oswestry Disability Index (ODI) of 22 points or more; Numeric Rating Scale (NRS) back pain improvement of 2 or more points, and NRS leg pain improvement of 4 or more points. Machine learning models were trained for model development and internal-external cross-validation applied over geographic regions to validate the models. Model performance was assessed through discrimination (C statistic) and calibration (slope and intercept). Results: Analysis included 22â¯707 surgical cases (21 161 patients) (ODI model) (mean [SD] age, 47.0 [14.0] years; 12â¯952 [57.0%] males). Treatment nonsuccess was experienced by 33% (ODI), 27% (NRS back pain), and 31% (NRS leg pain) of the patients. In internal-external cross-validation, the selected machine learning models showed consistent discrimination and calibration across all 5 regions. The C statistic ranged from 0.81 to 0.84 (pooled random-effects meta-analysis estimate, 0.82; 95% CI, 0.81-0.84) for the ODI model. Calibration slopes (point estimates, 0.94-1.03; pooled estimate, 0.99; 95% CI, 0.93-1.06) and calibration intercepts (point estimates, -0.05 to 0.11; pooled estimate, 0.01; 95% CI, -0.07 to 0.10) were also consistent across regions. For NRS back pain, the C statistic ranged from 0.75 to 0.80 (pooled estimate, 0.77; 95% CI, 0.75-0.79); for NRS leg pain, the C statistic ranged from 0.74 to 0.77 (pooled estimate, 0.75; 95% CI, 0.74-0.76). Only minor heterogeneity was found in calibration slopes and intercepts. Conclusion: The findings of this study suggest that the models developed can inform patients and clinicians about individual prognosis and aid in surgical decision-making.
Subject(s)
Back Pain , Intervertebral Disc Displacement , Female , Humans , Male , Middle Aged , Calibration , Intervertebral Disc Displacement/surgery , Machine Learning , Nonoxynol , Prospective Studies , AdultABSTRACT
BACKGROUND: Back pain is the number one condition contributing to years lived with disability worldwide, and one of the most common reasons for seeking primary care. Research on this condition in the ageing population is sparse. Further, the heterogeneity of patients with back pain complicates the management in clinical care. It is possible that subgrouping people with similar characteristics would improve management. This paper aimed to identify latent classes based on demographics, pain characteristics, psychosocial behavior, and beliefs and attitudes about back pain, among older patients seeking primary care with a new episode of back pain, and to examine if there were differences regarding the classes' first point-of-contact. METHODS: The study was part of the international BACE (Back complaints in elders) consortium and included 435 patients aged ≥ 55 years seeking primary care (general practitioners, physiotherapists, and chiropractors) in Norway from April 2015 to March 2020. A latent class analysis was performed to identify latent classes. The classes were described in terms of baseline characteristics and first point-of-contact in primary care. RESULTS: Four latent classes were identified. The mean age was similar across groups, as were high expectations towards improvement. Class 1 (n = 169, 39%), the "positive" class, had more positive attitudes and beliefs, less pain catastrophizing and shorter duration of current pain episode. Class 2 (n = 31, 7%), the "fearful" class, exhibited the most fear avoidance behavior, and had higher mean pain intensity. Class 3 (n = 33, 8%), the "distressed" class, had the highest scores on depression, disability, and catastrophizing. Finally, class 4 (n = 202, 46%), the "hopeful" class, showed the highest expectations for recovery, although having high pain intensity. The identified four classes showed high internal homogeneity, sufficient between-group heterogeneity and were considered clinically meaningful. The distribution of first point-of-contact was similar across classes, except for the positive class where significantly more patients visited chiropractors compared to general practitioners and physiotherapists. CONCLUSIONS: The identified classes may contribute to targeting clinical management of these patients. Longitudinal research on these latent classes is needed to explore whether the latent classes have prognostic value. Validation studies are needed to evaluate external validity. TRIAL REGISTRATION: Clinicaltrials.gov NCT04261309.
Subject(s)
Disabled Persons , Low Back Pain , Aged , Humans , Fear , Low Back Pain/epidemiology , Primary Health Care , Prognosis , Middle AgedABSTRACT
OBJECTIVES: This study evaluates the six-month cost-effectiveness and cost-benefits of motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) added to usual case management (UC) for workers on sick leave due to musculoskeletal disorders. METHODS: This study was conducted alongside a three-arm RCT including 514 employed workers on sick leave for at least 50% for ≥ 7 weeks. All participants received UC. The UC + MI group received two MI sessions, and the UC + SVAI group received 1-4 SVAI sessions. Sickness absence days, quality-adjusted life-years (QALYs), and societal costs were measured between baseline and six months. RESULTS: Adding MI to UC, resulted in incremental cost-reduction of -2580EUR (95%CI -5687;612), and a reduction in QALYs of -0.001 (95%CI -0.02;0.01). Secondly, adding MI to UC resulted in an incremental cost-reduction of -538EUR (95%CI -1358;352), and reduction of 5.08 (95%CI -3.3;13.5) sickness-absence days. Financial return estimates were positive, but not statistically significant. Adding SVAI to UC, resulted in an incremental cost-reduction of -2899 EUR (95% CI -5840;18), and a reduction in QALYs of 0.002 (95% CI -0.02;0.01). Secondly, adding SVAI to UC resulted in an statistically significant incremental cost-reduction of -695 EUR (95% CI -1459;-3), and a reduction of 7.9 (95% CI -0.04;15.9) sickness absence days. Financial return estimates were positive and statistically significant. The probabilities of cost-effectiveness for QALYs were high for adding MI or SVAI (ceiling ratio 0.90). CONCLUSIONS: In comparison to UC only, adding MI to UC tends to be cost-effective. Adding SVAI to UC is cost-effective for workers on sick leave due to musculoskeletal disorders. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03871712).
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STUDY DESIGN: Secondary analyses of a randomized trial [Antibiotics In Modic changes (MCs) study]. OBJECTIVE: To assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP). SUMMARY OF BACKGROUND DATA: It is not clear whether or not reduced MC edema implies improved clinical outcomes. PATIENTS AND METHODS: Linear regression was conducted separately in 2 subgroups with MC edema at baseline on short tau inversion recovery (STIR) or T1/T2-weighted magnetic resonance imaging, respectively. Independent variable: reduced edema (yes/no) at 1 year on STIR or T1/T2-series, respectively. Dependent variable: 1-year score on the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), or 0 to 10 numeric rating scale for LBP intensity, adjusted for the baseline score, age, smoking, body mass index, physical workload, and baseline edema on STIR (STIR analysis only). Post hoc, we, in addition, adjusted all analyses for baseline edema on STIR, treatment group (amoxicillin/placebo), and prior disc surgery-or for disc degeneration. RESULTS: Among patients with MC edema on STIR at baseline (n = 162), reduced edema on STIR was not significantly related to the RMDQ ( B : -1.0, 95% CI: -2.8, 0.8; P = 0.27), ODI ( B :-1.4, 95% CI: -5.4, 2.6; P = 0.50), or LBP intensity scores ( B : -0.05, 95% CI: -0.8, 0.7; P = 0.90) after 1 year. Among patients with MC edema on T1/T2-series at baseline (n = 116), reduced edema on T1/T2 ( i.e ., reduced volume of the type 1 part of MCs) was not significantly related to RMDQ ( B: -1.7, 95% CI: -3.8, 0.3; P = 0.10) or ODI score ( B : -2.3, 95% CI: -7.1, 2.5; P = 0.34) but was significantly related to LBP intensity at 1 year ( B : -0.9, 95% CI: -1.8, -0.04; P = 0.04; correlation coefficient: 0.24). The post hoc analyses supported these results. CONCLUSION: Reduced MC edema over 1 year was not significantly associated with pain-related disability but was (on T1/T2-series) significantly but weakly related to reduced LBP intensity. LEVEL OF EVIDENCE: Level 3.
Subject(s)
Chronic Pain , Disabled Persons , Intervertebral Disc Degeneration , Low Back Pain , Humans , Amoxicillin/therapeutic use , Anti-Bacterial Agents/therapeutic use , Chronic Pain/drug therapy , Chronic Pain/complications , Intervertebral Disc Degeneration/complications , Low Back Pain/complicationsABSTRACT
OBJECTIVE: To evaluate the efficacy of strength exercise or aerobic exercise compared to usual care on knee-related quality of life (QoL) and knee function at 4 months and 1 year in individuals with knee osteoarthritis. METHODS: A three-arm randomized controlled trial (RCT) compared 12 weeks of strength exercise or aerobic exercise (stationary cycling) to usual care supervised by physiotherapists in primary care. We recruited 168 participants aged 35-70 years with symptomatic knee osteoarthritis. The primary outcome was The Knee Injury and Osteoarthritis Outcome Score (KOOS) QoL at 1 year. Secondary outcomes were self-reported function, pain, and self-efficacy, muscle strength and maximal oxygen uptake (VO2max) at 4 months and 1 year. RESULTS: There were no differences between strength exercise and usual care on KOOS QoL (6.5, 95% CI -0.9 to 14), or for aerobic exercise and usual care (5.0, 95% CI -2.7 to 12.8), at 1 year. The two exercise groups showed better quadriceps muscle strength, and VO2max at 4 months, compared to usual care. CONCLUSION: This trial found no statistically significant effects of two exercise programs compared to usual care on KOOS QoL at 1 year in individuals with symptomatic and radiographic knee osteoarthritis, but an underpowered sample size may explain lack of efficacy between the intervention groups and the usual care group. GOV IDENTIFIER: NCT01682980.
Subject(s)
Osteoarthritis, Knee , Humans , Osteoarthritis, Knee/therapy , Follow-Up Studies , Knee Joint , Exercise , Quality of LifeABSTRACT
OBJECTIVE: This study aimed to evaluate the effectiveness of motivational interviewing (MI) - a counselling approach offered by caseworkers at the Norwegian Labor and Welfare Administration (NAV) - on return to work (RTW) for individuals sick-listed for ≥8 weeks due to any diagnoses. MI was compared to usual case management and an active control during 12 months of follow-up. METHODS: In a randomized clinical trial with three parallel arms, participants were randomized to MI (N=257), usual case management (N=266), or an active control group (N=252). MI consisted of two MI sessions while the active control involved two sessions without MI, both were offered in addition to usual case management. The primary outcome was number of sickness absence days based on registry data. Secondary outcomes included time to sustainable RTW, defined as four consecutive weeks without medical benefits. RESULTS: The median number of sickness absence days for the MI group was 73 days [interquartile range (IQR) 31-147], 76 days (35-134) for usual care, and 75 days (34-155) for active control. In total 89%, 88% and 86% of the participants, respectively, achieved sustainable RTW. The adjusted hazard ratio (HR) for time to sustainable RTW was 1.12 (95% CI 0.90-1.40) for MI compared to usual case management and HR 1.16 (95% CI 0.93-1.44) compared to the active control. CONCLUSIONS: This study did not provide evidence that MI offered by NAV caseworkers to sick-listed individuals was more effective on RTW than usual case management or an active control. Providing MI in this context could be challenging as only half of the MI group received the intervention.
Subject(s)
Motivational Interviewing , Humans , Social Security , Sick Leave , Employment , Return to WorkABSTRACT
ABSTRACT: Prognostic prediction models for 3 different definitions of nonrecovery were developed in the Back Complaints in the Elders study in the Netherlands. The models' performance was good (optimism-adjusted area under receiver operating characteristics [AUC] curve ≥0.77, R2 ≥0.3). This study aimed to assess the external validity of the 3 prognostic prediction models in the Norwegian Back Complaints in the Elders study. We conducted a prospective cohort study, including 452 patients aged ≥55 years, seeking primary care for a new episode of back pain. Nonrecovery was defined for 2 outcomes, combining 6- and 12-month follow-up data: Persistent back pain (≥3/10 on numeric rating scale) and persistent disability (≥4/24 on Roland-Morris Disability Questionnaire). We could not assess the third model (self-reported nonrecovery) because of substantial missing data (>50%). The models consisted of biopsychosocial prognostic factors. First, we assessed Nagelkerke R2 , discrimination (AUC) and calibration (calibration-in-the-large [CITL], slope, and calibration plot). Step 2 was to recalibrate the models based on CITL and slope. Step 3 was to reestimate the model coefficients and assess if this improved performance. The back pain model demonstrated acceptable discrimination (AUC 0.74, 95% confidence interval: 0.69-0.79), and R2 was 0.23. The disability model demonstrated excellent discrimination (AUC 0.81, 95% confidence interval: 0.76-0.85), and R2 was 0.35. Both models had poor calibration (CITL <0, slope <1). Recalibration yielded acceptable calibration for both models, according to the calibration plots. Step 3 did not improve performance substantially. The recalibrated models may need further external validation, and the models' clinical impact should be assessed.
Subject(s)
Back Pain , Low Back Pain , Humans , Aged , Prognosis , Prospective Studies , Back Pain/diagnosis , Back Pain/therapy , Primary Health CareABSTRACT
BACKGROUND: Patients with chronic low back pain (LBP) and lumbar disc degeneration are recommended to try out nonsurgical treatment options before surgery. There is need for good nonsurgical alternatives that can be adapted to the patient's needs and level of function. The aim of this pilot trial was to test study feasibility of a future full randomized controlled trial (RCT) evaluating the feasibility and benefit of the physiotherapy-based Godelieve Denys-Struyf (GDS) muscle and articulation chain treatment for patients with chronic LBP and lumbar disc degeneration referred to surgical assessment in a hospital outpatient clinic. METHODS: This study is a single-center, two-arm, single-blinded, pilot RCT conducted in a regional hospital in Norway. Patients of age 35-75 years with chronic (> 3 months) LBP and degenerative lumbar disc(s) verified by imaging were included. They filled in a baseline questionnaire prior to randomization, including the Oswestry Disability Index (ODI), numerical rating scale for pain in back and pain in leg, and the EuroQoL 5L. Patients in the control group were free to use treatment as usual. Patients in the intervention group received 8 sessions over a period of 10 to 14 weeks of GDS muscle and articulation chain treatment. RESULTS: The recruitment rate was slow, approximately 3/4th of the referred patients met the inclusion criteria, but majority of eligible participants (94%) were willing to participate. A total of 30 patients were randomized into the two groups. The randomization led to skewed distribution of radiating leg pain in the two groups. All participants except one (97%) completed 4 months follow-up. No serious adverse events attributable to the trial treatments were reported. The Oswestry Disability Index (ODI) and leg pain intensity scale were both suitable as primary outcomes in a full trial. The mean change in the ODI score was 8.7 (SD 16.1) points in the GDS arm, whereas there was a minor deterioration in the ODI scores of -3.7 (7.5) points in the control arm. A sample size calculation based on the ODI scores resulted in a number needed to treat of 3. CONCLUSIONS: A future full RCT is feasible and would provide evidence about the effectiveness of a GDS treatment for patients with chronic LBP and lumbar disc degeneration. TRIAL REGISTRATION: ClinicalTrials.gov ID: 910193.