Developing clinical prediction models for nonrecovery in older patients seeking care for back pain: the back complaints in the elders prospective cohort study.

ABSTRACT: Back pain is a leading cause of disability worldwide and is common in older adults. No clinical prediction models for poor long-term outcomes have been developed in older patients with back pain. This study aimed to develop and internally validate 3 clinical prediction models for nonrecovery in this population. A prospective cohort study in general practice was conducted (Back Complaints in the Elders, Netherlands), including 675 patients >55 years with a new episode of care for back pain. Three definitions of nonrecovery were used combining 6-month and 12-month follow-up data: (1) persistent back pain, (2) persistent disability, and (3) perceived nonrecovery. Sample size calculation resulted in a maximum of 14 candidate predictors that were selected from back pain prognostic literature and clinical experience. Multivariable logistic regression was used to develop the models (backward selection procedure). Models' performance was evaluated with explained variance (Nagelkerke's R2), calibration (Hosmer-Lemeshow test), and discrimination (area under the curve [AUC]) measures. The models were internally validated in 250 bootstrapped samples to correct for overoptimism. All 3 models displayed good overall performance during development and internal validation (ie, R2 > 30%; AUC > 0.77). The model predicting persistent disability performed best, showing good calibration, discrimination (AUC 0.86, 95% confidence interval 0.83-0.89; optimism-adjusted AUC 0.85), and explained variance (R2 49%, optimism-adjusted R2 46%). Common predictors in all models were: age, chronic duration, disability, a recent back pain episode, and patients' recovery expectations. Spinal morning stiffness and pain during spinal rotation were included in 2 of 3 models. These models should be externally validated before being used in a clinical primary care setting.

Natural History of Back Pain in Older Adults over Five Years.

INTRODUCTION: Back pain is a prevalent health problem. Research often focuses on adults. Evidence on the long-term course of back pain in older patients is limited. A prospective cohort study (BACE) was conducted in a primary care setting in the Netherlands. We aim to investigate the 5-year course and medical consumption of older adults (>55 years) presenting with back pain in general practice. METHODS: Patients aged >55 years, consulting their general practitioner with a new back pain episode, were included between 2009 to 2011. Follow-up questionnaires included, for example, pain severity, disability, quality of life, recovery, and medical consumption. RESULTS: A total of 675 patients (mean age ± SD, 66.4 ± 7.6 years) participated, showing a mean (± SD) back pain reduction from 5.2 (± 2.7) to 3.6 (± 2.8) (numeric rating scale, 0 to 10) at 3 months follow-up; disability decreased from 9.8 (± 5.8) to 7.8 (± 6.2) (Roland-Morris Disability Questionnaire, 0 to 24). After 6 months, this remained practically constant over time. Medical consumption was highest in the first months; medication was used by 72% at baseline and approximately one-third (25% to 39%) during follow-up. At 5-year follow-up (response rate 58%; n = 392), 43% had recovered; a majority reported persistent or recurrent back pain. CONCLUSION: Clinically relevant improvements in back pain intensity and disability were seen in the first 3 to 6 months of follow-up. A majority of patients does not become pain free within 3 months; this does not improve over 5 years. However, most patients stop consulting health care professionals during follow-up. Current medical strategies may not be sufficient in older back pain patients, where back pain becomes a recurrent or chronic condition in the majority of patients.

No association between low bone quality and back pain in older adults: A cohort study.

BACKGROUND: It is unclear whether bone quality associates with severity and prognosis of back pain. OBJECTIVES: To investigate the association between bone quality and back pain severity at baseline, and whether low bone quality is a prognostic factor for persistent back pain in patients aged over 55 years at 1-year follow-up. METHODS: In this prospective cohort study persistent back pain was defined as a decrease in the back pain severity score of less than 30% at 1-year follow-up compared with baseline score or as a back pain severity score greater than 1 (0-10: 0 = no pain) Low bone quality was categorized as a T-score, calculated using a stiffness index by quantitative ultrasound of the heel, of 2.5 or below. Data were analyzed in multiple regression analyses. RESULTS: Of all 513 patients, 68 (13%) showed low bone quality at baseline. Back pain severity showed no differences between patients with normal and with low bone quality. At 1-year follow-up, low bone quality was not associated with persistent back pain (defined as < 30%: OR 1.0; 95% CI: 0.40-2.30, p-value = 0.93; and defined as score > 1: OR 0.4; 95% CI: 0.17-1.15), p-value = 0.09), adjusted for all covariates. CONCLUSIONS: In older adults with back pain presenting in general practice, low bone quality was not associated with severity of back pain at baseline nor with persistent back pain at 1-year follow-up.

NSAIDs for Chronic Low Back Pain.

Clinical Question: Are nonsteroidal anti-inflammatory drugs (NSAIDs) associated with greater pain relief than placebo, other drugs, and nondrug treatments for patients with chronic low back pain? Bottom Line: Compared with placebo, NSAIDs are associated with a small but significant improvement in pain and disability in patients with chronic low back pain, although this difference became nonsignificant when studies with high risk for bias were excluded. The associated benefits were smaller than the minimal clinically important difference.

Back Complaints in the Elders in Brazil and the Netherlands: a cross-sectional comparison.

Background: although back pain is most prevalent in older adults, there is a paucity of studies investigating back pain in older people. Our objective was to characterize and compare Brazilian and Dutch older adults presenting to primary care with a new episode of back pain. We also aimed to investigate whether socio-demographic characteristics were associated with pain severity and disability. Methods: we sourced data on 602 Brazilian and 675 Dutch participants aged ≥55 years with a new episode of back pain from the Back Complaints in the Elders consortium. We analyzed country differences in participants' characteristics, and associations between socio-demographic/clinical characteristics and pain severity and pain-related disability. Results: the two populations differed in most characteristics. More Dutch participants were smokers, heavy drinkers, and reported back stiffness. More Brazilian participants were less educated, had higher prevalence of comorbidities; higher levels of pain intensity, disability and psychological distress. When controlling for the effect of country, being female and having altered quality of sleep were associated with higher pain intensity. Altered quality of sleep, having two or more comorbidities and physical inactivity were associated with higher disability. Higher educational levels were negatively associated with both pain and disability outcomes. Conclusions: back pain is disabling in the older population. Our country comparison has shown that country of residence is an important determinant of higher disability and pain in older people with back pain. Irrespective of country, women with poor sleep quality, comorbidities, low education and who are physically inactive report more severe symptoms.

Defining trajectories in older adults with back pain presenting in general practice.

BACKGROUND: although back pain is a frequently recurring disorder, the course of back pain remains uncertain. Therefore, this study aimed to identify different trajectories in older adults with back pain who presented in general practice and to determine which baseline characteristics are associated with these trajectories. METHODS: the BACE study is a prospective cohort study including 675 patients (aged >55 years) with back pain who consulted a general practitioner; patients were followed for 3 years. Latent class growth analysis was used to identify different trajectories in back pain severity measured at eight different time points. A multinomial regression analysis was used to assess variables associated with membership of an identified trajectory. RESULTS: using the different indices of fit and the usefulness of the different trajectories in clinical practice, a 3-class cubic model was determined to be the best model. The three trajectories were defined as 'low pain trajectory', 'high pain trajectory' and 'intermediate pain trajectory'. Baseline variables associated with a higher chance of being in the intermediate or high trajectory were: female gender, higher body mass index, chronic back pain, more disability, lower scores on the SF-36 physical summary scale, and negative expectations of recovery. CONCLUSIONS: three different back pain trajectories were identified in older adults presenting with back pain in general practice. Various baseline characteristics were associated with a higher chance of being in the high or intermediate back pain trajectory. These characteristics might help identify patients at risk for a less favourable outcome.

Non-steroidal anti-inflammatory drugs for chronic low back pain.

BACKGROUND: Chronic back pain is an important health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat people with low back pain, especially people with acute back pain. Short term NSAID use is also recommended for pain relief in people with chronic back pain. Two types of NSAIDs are available and used to treat back pain: non-selective NSAIDs and selective COX-2 NSAIDs. In 2008, a Cochrane review identified a small but significant effect from NSAIDs compared to placebo in people with chronic back pain. This is an update of the Cochrane review published in 2008 and focuses on people with chronic low back pain. OBJECTIVES: To determine if NSAIDs are more efficacious than various comparison treatments for non-specific chronic low back pain and if so, which type of NSAID is most efficacious. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, PubMed and two clinical trials registry databases up to 24 June 2015 for randomized controlled trials (RCTs) published in English, German or Dutch. We also screened references cited in relevant reviews. SELECTION CRITERIA: We included RCTs (double-blind and single-blind) of NSAIDs used to treat people with chronic low back pain. DATA COLLECTION AND ANALYSIS: Two review authors independently screened trials for inclusion in this Cochrane review according to the inclusion criteria. One review author extracted the data, and a second review author checked the data. Two review authors independently evaluated the risk of bias of all included trials. If data were clinically homogeneous, we performed a meta-analysis and assessed the quality of evidence using the GRADE approach. MAIN RESULTS: We included 13 trials in this Cochrane review. Ten studies were at 'low' risk of bias. Six studies compared NSAIDs with placebo, and included 1354 participants in total. There is low quality evidence that NSAIDs are more effective than placebo, with a mean difference in pain intensity score from baseline of -3.30 (95% CI -5.33 to -1.27) on a 0 to 100 visual analogue scale (VAS) with a median follow-up of 56 days (interquartile range (IQR) 13 to 91 days). Four studies measured disability using the Roland Morris Disability Questionnaire. There is low quality evidence that NSAIDs are more effective than placebo on disability, with a mean difference from baseline of -0.85 (95% CI -1.30 to -0.40) on a scale from 0 to 24 with a median follow-up of 84 days (IQR 42 to 105 days). All six placebo controlled studies also reported adverse events, and suggested that adverse events are not statistically significant more frequent in participants using NSAIDs compared to placebo (RR 1.04, 95% CI 0.92 to 1.17). Due to the relatively small sample size and relatively short follow-up in most included trials, it is likely that the proportion of patients experiencing an adverse event is underestimated.Two studies compared different types of non-selective NSAIDs, namely ibuprofen versus diclofenac and piroxicam versus indomethacin. The trials did not find any differences between these NSAID types, but both trials had small sample sizes. One trial reported no differences in pain intensity between treatment groups that used selective or non-selective NSAIDs. One other trial compared diflunisal with paracetamol and showed no difference in improvement from baseline on pain intensity score. One trial showed a better global improvement in favour of celecoxib versus tramadol.One included trial compared NSAIDs with 'home-based exercise'. Disability improved more in participants who did exercises versus participants receiving NSAIDs, but pain scores were similar. AUTHORS' CONCLUSIONS: Six of the 13 included RCTs showed that NSAIDs are more effective than placebo regarding pain intensity. NSAIDs are slightly more effective than placebo regarding disability. However, the magnitude of the effects is small, and the level of evidence was low. When we only included RCTs at low risk of bias, differences in effect between NSAIDs and placebo were reduced. We identified no difference in efficacy between different NSAID types, including selective versus non-selective NSAIDs. Due to inclusion of RCTs only, the relatively small sample sizes and relatively short follow-up in most included trials, we cannot make firm statements about the occurrence of adverse events or whether NSAIDs are safe for long-term use.

Prevalence and "Red Flags" Regarding Specified Causes of Back Pain in Older Adults Presenting in General Practice.

BACKGROUND: In a small proportion of patients experiencing unspecified back pain, a specified underlying pathology is present. OBJECTIVE: The purposes of this study were: (1) to identify the prevalence of physician-specified causes of back pain and (2) to assess associations between "red flags" and vertebral fractures, as diagnosed by the patients' general practitioner (GP), in older adults with back pain. METHODS: The Back Complaints in the Elders (BACE) study is a prospective cohort study. Patients (aged >55 years) with back pain were included when consulting their GP. A questionnaire was administered and a physical examination and heel bone densitometry were performed, and the results determined back pain and patient characteristics, including red flags. Participants received a radiograph, and reports were sent to their GP. The final diagnoses established at 1 year were collected from the GP's patient registry. RESULTS: Of the 669 participants included, 6% were diagnosed with a serious underlying pathology during the 1-year follow-up. Most of these participants (n=33, 5%) were diagnosed with a vertebral fracture. Multivariable regression analysis showed that age of ≥75 years, trauma, osteoporosis, a back pain intensity score of ≥7, and thoracic pain were associated with a higher chance of getting the diagnosis of a vertebral fracture. Of these variables, trauma showed the highest positive predictive value for vertebral fracture of 0.25 (95% confidence interval=0.09, 0.41) and a positive likelihood ratio of 6.2 (95% confidence interval=2.8, 13.5). A diagnostic prediction model including the 5 red flags did not increase these values. LIMITATIONS: Low prevalence of vertebral fractures could have led to findings by chance. CONCLUSIONS: In these older adults with back pain presenting in general practice, 6% were diagnosed with serious pathology, mainly a vertebral fracture (5%). Four red flags were associated with the presence of vertebral fracture.

Analgesic use in older adults with back pain: the BACE study.

BACKGROUND: Older patients with back pain are more likely to visit their general practitioner (GP) and are more likely to be prescribed analgesics. OBJECTIVE: To assess analgesic use in older adults with back pain in general practice. METHODS: The BACE study in the Netherlands is a prospective cohort study. Patients (aged >55 years) with back complaints were recruited when consulting their GP or shortly thereafter. Measurements took place at baseline and at 3- and 6-month follow-up. For medication use, patients were asked if they had used any medication for their back pain in the previous 3 months and, if so, to specify the medication name, dosage used, frequency of usage, and whether the medication was prescribed or purchased over the counter. RESULTS: Of the 1,402 patients who were approached to enter the study, 675 were included. Of these patients, 484 (72%) reported medication use at baseline. Nonsteroidal anti-inflammatory drugs (NSAIDs) (57%) were more often used than paracetamol (49%). Paracetamol was mostly obtained over the counter (69%), and NSAIDs were mostly obtained by prescription (85%). At baseline, patients with severe pain (numerical rating scale score ≥7) used more paracetamol, opioids, and muscle relaxants. Patients with chronic pain (back pain >3 months) used more paracetamol, while patients with a shorter duration of pain used more NSAIDs. During follow-up there was an overall decline in medication use; however, at 3- and 6-month follow-up, 36% and 30% of the patients, respectively, still used analgesics. CONCLUSIONS: In these older adults consulting their GP with back pain, 72% used analgesics at baseline. Despite a decrease in medication use during follow-up, at 3 and 6 months a considerable proportion still used analgesics.

Back complaints in older adults: prevalence of neuropathic pain and its characteristics.

OBJECTIVE: Neuropathic symptoms are reported in 16-55.6% of patients with back pain. Studies were performed in various populations; however, none focused on older adults. The aim of the study was to assess prevalence of neuropathic pain in older adults with back pain. METHODS: Prevalence of neuropathic pain, measured with the Dolour Neuropathique en 4 questions (DN4), was assessed in the Back Complaints in the Elders study (Netherlands). Patients (>55 years) consulting their general practitioner with a new episode of back complaints were included. Two DN4-versions were used: one based on interview plus physical examination, the other based on interview alone. In the interview plus physical examination version, patients' and complaint characteristics were compared between groups with different scores (0, 1, 2, 3, and ≥4). The DN4 interview-version compared patients with negative and positive scores. RESULTS: Of the 261 included patients available for analysis were 250 patients (95.8%) with the DN4 interview plus physical examination, and 259 patients (99.2%) with the DN4 interview. In DN4 interview plus physical examination (N = 250), five patients (2%) scored positive (score ≥4). Higher score was associated with pain radiating below the knee (P < 0.001) and use of paracetamol (P = 0.02). In DN4 interview (N = 259), 29 (11.2%) patients scored positive (score ≥3). Positive score was associated with higher body mass index (P = 0.01), pain radiating below the knee (P = 0.001), and use of paracetamol (P = 0.002). CONCLUSIONS: In older adults with back pain presenting with a new episode in primary care, prevalence of neuropathic pain is low and seems to be associated with pain radiating below the knee, use of paracetamol, and higher body mass index.

Course and prognosis of older back pain patients in general practice: a prospective cohort study.

The aim of the current study was to determine the course of back pain in older patients and identify prognostic factors for non-recovery at 3 months' follow-up. We conducted a prospective cohort study (the BACE study) of patients aged >55 years visiting a general practitioner (GP) with a new episode of back pain in the Netherlands. The course of back pain was described in terms of self-perceived recovery, pain severity, disability, pain medication, and GP visits at 6 weeks' and 3 months' follow-up. Prognostic factors for non-recovery at 3 months' follow-up were derived from the baseline questionnaire and physical examination. Variables with a prognostic value were identified with multivariable logistic regression analysis (method backward), and an area under the receiver operating curve (AUC) was calculated for the prognostic model. A total of 675 back pain patients (mean age 66.4 (SD 7.6) years) participated in the BACE cohort study. At 6 weeks' follow-up 64% of the patients reported non-recovery from back pain. At 3 months' follow-up 61% still reported non-recovery, but only 26% of these patients had revisited the GP. Longer duration of the back pain, severity of back pain, history of back pain, absence of radiating pain in the leg below the knee, number of comorbidities, patients' expectation of non-recovery, and a longer duration of the timed 'Up and Go' test were significantly associated with non-recovery in a multiple regression model (AUC 0.79). This information can help GPs identify older back pain patients at risk for non-recovery.

Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial.

BACKGROUND: It is uncertain to what extent oral supplementation with zinc can reduce episodes of malaria in endemic areas. Protection may depend on other nutrients. We measured the effect of supplementation with zinc and other nutrients on malaria rates. METHODS AND FINDINGS: In a 2×2 factorial trial, 612 rural Tanzanian children aged 6-60 months in an area with intense malaria transmission and with height-for-age z-score≤-1.5 SD were randomized to receive daily oral supplementation with either zinc alone (10 mg), multi-nutrients without zinc, multi-nutrients with zinc, or placebo. Intervention group was indicated by colour code, but neither participants, researchers, nor field staff knew who received what intervention. Those with Plasmodium infection at baseline were treated with artemether-lumefantrine. The primary outcome, an episode of malaria, was assessed among children reported sick at a primary care clinic, and pre-defined as current Plasmodium infection with an inflammatory response, shown by axillary temperature ≥37.5°C or whole blood C-reactive protein concentration ≥ 8 mg/L. Nutritional indicators were assessed at baseline and at 251 days (median; 95% reference range: 191-296 days). In the primary intention-to-treat analysis, we adjusted for pre-specified baseline factors, using Cox regression models that accounted for multiple episodes per child. 592 children completed the study. The primary analysis included 1,572 malaria episodes during 526 child-years of observation (median follow-up: 331 days). Malaria incidence in groups receiving zinc, multi-nutrients without zinc, multi-nutrients with zinc and placebo was 2.89/child-year, 2.95/child-year, 3.26/child-year, and 2.87/child-year, respectively. There was no evidence that multi-nutrients influenced the effect of zinc (or vice versa). Neither zinc nor multi-nutrients influenced malaria rates (marginal analysis; adjusted HR, 95% CI: 1.04, 0.93-1.18 and 1.10, 0.97-1.24 respectively). The prevalence of zinc deficiency (plasma zinc concentration <9.9 µmol/L) was high at baseline (67% overall; 60% in those without inflammation) and strongly reduced by zinc supplementation. CONCLUSIONS: We found no evidence from this trial that zinc supplementation protected against malaria. TRIAL REGISTRATION: ClinicalTrials.gov NCT00623857