General Practitioners Referring Adults to MR Imaging for Knee Pain: A Randomized Controlled Trial to Assess Cost-effectiveness.

Purpose To determine the cost-effectiveness of early referral by the general practitioner for magnetic resonance (MR) imaging compared with usual care alone in patients aged 18-45 years with traumatic knee symptoms. Materials and Methods Cost-utility analysis was performed parallel to a prospective multicenter randomized controlled trial in Dutch general practice. A total of 356 patients with traumatic knee symptoms were included from November 2012 to December 2015 (mean age, 33 years ± 8 [standard deviation]; 222 men [62%]). Patients were randomly assigned to usual care (n = 177; MR imaging was not performed, but patients were referred to an orthopedic surgeon when conservative treatment was unsatisfactory) or MR imaging (n = 179) within 2 weeks after injury. Main outcome measures were quality-adjusted life years (QALYs) and costs from a healthcare and societal perspective. Multiple imputation was used for missing data. The Student t test was used to assess differences in mean QALYs, costs, and net benefits. Results Mean QALYs were 0.888 in the MR imaging group and 0.899 in the usual care group (P = .255). Healthcare costs per patient were higher in the MR imaging group (€1109) than in the usual care group (€837) (P = .050), mainly due to higher costs for MR imaging, with no reduction in the number of referrals to an orthopedic surgeon in the MR imaging group. Conclusion MR imaging referral by the general practitioner was not cost-effective in patients with traumatic knee symptoms; in fact, MR imaging led to more healthcare costs, without an improvement in health outcomes.

Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial.

OBJECTIVES: Guidelines recommend intra-articular glucocorticoid injection in patients with painful hip osteoarthritis. However, intra-articular hip injection is an invasive procedure. The efficacy of systemic glucocorticoid treatment for pain reduction in hip osteoarthritis is unknown. This randomised, double-blind, trial assessed effectiveness in hip pain reduction of an intramuscular glucocorticoid injection compared with a placebo injection in patients with hip osteoarthritis. METHODS: Patients with painful hip osteoarthritis were randomised to either 40 mg triamcinolone acetate or placebo with an intramuscular injection into the gluteus muscle. The primary outcomes were severity of hip pain at rest, during walking (0-10) and WOMAC pain at 2-week postinjection. We used linear mixed models for repeated measurements at 2, 4, 6 and 12 weeks for the intention-to-treat data analysis. RESULTS: Of the 107 patients randomised, 106 could be analysed (52 in the glucocorticoid group, 54 in the placebo group). At 2-week follow-up, compared with placebo injection, the intramuscular glucocorticoid injection showed a significant and clinically relevant difference in hip pain reduction at rest (difference -1.3, 95% CI -2.3 to -0.3). This effect persisted for the entire 12-week follow-up. For hip pain during walking, the effect was present at 4-week, 6-week and 12-week follow-ups, and for WOMAC pain the effect was present at 6-week and 12-week follow-up. CONCLUSIONS: An intramuscular glucocorticoid injection showed effectiveness in patients with hip osteoarthritis on one of the three primary outcomes at 2-week postinjection. All primary outcomes showed effectiveness from 4 to 6 weeks, up to a 12-week follow-up. TRIAL REGISTRATION NUMBER: NTR2966.

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.

Prevalence of spinal pathology in patients presenting for lumbar MRI as referred from general practice.

BACKGROUND: The use of magnetic resonance imaging (MRI) as initial imaging for back pain has increased in general practice. However, few data are available on the characteristics of these referred patients. The objective of this study was to describe the baseline characteristics and MRI findings of patients presenting for a lumbar MRI examination as referred by their GP. METHODS: Patients presenting for a lumbar MRI examination as referred by their GP were recruited at the MRI Center. The MRI radiology reports were scored for the presence of disc bulging, disc herniation, nerve root compression, spinal stenosis, spondylolisthesis and serious pathologies. Information on patients' characteristics, characteristics of the complaints and red flags were derived from questionnaires. Cross-sectional differences between patients with and without specific MRI findings were analyzed. RESULTS: A total of 683 low back pain (LBP) patients were included; mean age was 49.9 (range 19-80) years and 53% was male. Mean back pain severity score was 6.6 (SD 2.0) and 67% of the patients reported having chronic LBP. In total, 374 patients (55%) reported sciatica complaints for at least 6 weeks. Of all MRI reports, 69% mentioned signs of nerve root compression. Serious pathologies were reported in 3% of the patients. In total, 94% of patients had abnormal MRI findings. CONCLUSIONS: Almost all patients presenting for a lumbar MRI examination as referred by their GP had abnormal MRI findings. In total, 55% of the patients reported persistent sciatica in which imaging is recommended according to international guidelines.

The added prognostic value of MRI findings for recovery in patients with low back pain in primary care: a 1-year follow-up cohort study.

PURPOSE: Information on the prognostic value of MRI findings in low back pain patients in primary care is lacking. The objective of this study is to investigate the added prognostic value of baseline MRI findings over known prognostic factors for recovery at 12-month follow-up in patients with low back pain referred to MRI by their general practitioner. METHODS: Patients referred by their general practitioner for MRI of the lumbar spine were recruited at the MRI Center. The questionnaires at baseline and at 3 and 12-months follow-up included potential clinical predictors from history taking and the outcome recovery. The MRI radiology reports were scored. Analysis was performed in 3 steps: derivation of a predictive model including characteristics of the patients and back pain only (history taking), including reported MRI findings only, and the addition of reported MRI findings to the characteristics of the patients and back pain. RESULTS: At 12-months follow-up 53% of the patients reported recovery (n = 683). Lower age, better attitude/beliefs regarding back pain, acute back pain, presence of neurological symptoms of the leg(s), and presence of non-continuous back pain were significantly associated with recovery at 12-months follow-up: area under the curve (AUC) 0.77. Addition of the MRI findings resulted in an AUC of 0.78. CONCLUSIONS: At 12-months follow-up, only 53% of these patients with low back pain referred for MRI in general practice reported recovery. Five clinic baseline characteristics were associated with recovery at 12-months follow-up; adding the MRI findings did not result in a stronger prediction of recovery.

Knee instability in patients with traumatic knee disorders: a cohort study in primary care.

BACKGROUND: There is a lack of knowledge about the course of knee instability in patients with traumatic knee disorders. OBJECTIVE: The aim of the study was to determine the course of traumatic knee instability during 1-year follow-up and to observe the treatment of knee instability by GPs. METHODS: Patients (n = 134) aged 18-65 years with traumatic knee disorders who consulted their GP within 5 weeks after trauma were enrolled in a prospective cohort study. Data were collected at baseline and at 3, 6 and 12 months follow-up. Magnetic resonance imaging (MRI) and physical examination of the knee were performed at baseline and at 1-year follow-up. RESULTS: At baseline, 28% of the 134 patients had no knee instability, 17% reported knee instability (according Lysholm score), 31% tested positive on knee instability (according Lachman test) and 24% both self-reported and tested positive on instability of the knee. At baseline and at 1-year follow-up, no clear differences between MRI findings, treatment and course of the defined groups of knee instability were found. At 1-year follow-up, patients with both self-reported and tested positive seemed to have worse outcomes. CONCLUSION: During 1-year follow-up, it was unclear if there were differences regarding course, treatment and MRI findings of the knee between no instability and the three defined knee instability groups. Statistical power was lacking in the comparisons made and therefore studies with more patients are needed.

Adverse drug reactions in a primary care population prescribed non-steroidal anti-inflammatory drugs.

OBJECTIVE: To determine how often patients with musculoskeletal (MSK) complaints prescribed a non-steroidal anti-inflammatory drug (NSAID) subsequently consult their general practitioner (GP) with a non-serious adverse drug reaction (ADR). DESIGN: Cohort study. SETTING: A healthcare database containing the electronic GP medical records of over 1.5 million patients throughout the Netherlands. PATIENTS: A total of 16 626 adult patients with MSK complaints prescribed an NSAID. MAIN OUTCOME MEASURES: The patients' medical records were manually assessed for the duration of NSAID use for a maximum of two months, and consultations for complaints predefined as potential ADRs were identified. Subsequently, the likelihood of an association with the NSAID use was assessed and these potential ADRs were categorized as likely, possible, or unlikely ADRs. RESULTS: In total, 961 patients (6%) consulted their GP with 1227 non-serious potential ADRs. In 174 patients (1%) at least one of these was categorized as a likely ADR, and in a further 408 patients (2.5%) at least one was categorized as a possible ADR. Dyspepsia was the most frequent likely ADR, followed by diarrhoea and dyspnoea (respectively 34%, 8%, and 8% of all likely ADRs). CONCLUSION: Of the patients with MSK complaints prescribed an NSAID, almost one in 30 patients re-consulted their GP with a complaint likely or possibly associated with the use of this drug. The burden of such consultations for non-serious ADRs should be taken into account by GPs when deciding whether treatment with an NSAID is appropriate.

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.

Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomised controlled non-inferiority trial (TACKLE trial).

BACKGROUND: Patients with traumatic knee complaints regularly consult their general practitioner (GP). MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs. Therefore, this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care, in patients with persistent traumatic knee complaints. DESIGN AND METHODS: This is a multi-centre, open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study. Eligible patients (aged 18-45 years) have knee complaints due to trauma (or sudden onset) occurring in the preceding 6 months and consulting their GP. Participants are randomised to: 1) an MRI group, i.e. GP referral to MRI, or 2) a usual care group, i.e. no MRI. Primary outcomes are knee-related daily function, medical costs (healthcare use and productivity loss), and quality of life. Secondary outcomes are disability due to knee complaints, severity of knee pain, and patients' perceived recovery and satisfaction. Outcomes are measured at baseline and at 1.5, 3, 6, 9 and 12 months follow-up. Also collected are data on patient demographics, GPs' initial working diagnosis, GPs' preferred management at baseline, and MRI findings. DISCUSSION: In the Netherlands, the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown. Although GPs increasingly refer patients to MRI, the Dutch clinical guideline 'Traumatic knee complaints' for GPs does not recommend referral to MRI, mainly because the cost-effectiveness is still unknown. TRIAL REGISTRATION: Dutch Trial Registration: NTR3689.

Ischaemic cardiovascular risk and prescription of non-steroidal anti-inflammatory drugs for musculoskeletal complaints.

OBJECTIVE: To determine the influence of ischaemic cardiovascular (CV) risk on prescription of non-steroidal anti-inflammatory drugs (NSAIDs) by general practitioners (GPs) in patients with musculoskeletal complaints. DESIGN: Cohort study. SETTING: A healthcare database containing the electronic GP medical records of over one million patients throughout the Netherlands. PATIENTS: A total of 474 201 adults consulting their GP with a new musculoskeletal complaint between 2000 and 2010. Patients were considered at high CV risk if they had a history of myocardial infarction, angina pectoris, stroke, transient ischaemic attack, or peripheral arterial disease, and at low CV risk if they had no CV risk factors. MAIN OUTCOME MEASURES: Frequency of prescription of non-selective (ns)NSAIDs and selective cyclooxygenase-2 inhibitors (coxibs). RESULTS: Overall, 24.4% of patients were prescribed an nsNSAID and 1.4% a coxib. Of the 41,483 patients with a high CV risk, 19.9% received an nsNSAID and 2.2% a coxib. These patients were more likely to be prescribed a coxib than patients with a low CV risk (OR 1.9, 95% CI 1.8-2.0). Prescription of nsNSAIDs decreased over time in all risk groups and was lower in patients with a high CV risk than in patients with a low CV risk (OR 0.8, 95% CI 0.7-0.8). CONCLUSION: Overall, patients with a high CV risk were less likely to be prescribed an NSAID for musculoskeletal complaints than patients with a low CV risk. Nevertheless, one in five high CV risk patients received an NSAID, indicating that there is still room for improvement.

Is anesthetic hip joint injection useful in diagnosing hip osteoarthritis? A meta-analysis of case series.

To assess the diagnostic value of intra-articular anesthetic hip injection in patients with hip pain atypical for osteoarthritis (OA), literature was searched. Included were studies assessing the diagnostic value of anesthetic hip injections in differentiating between pain caused by OA or another source. Pooled estimates of sensitivity and specificity with 95% confidence intervals (CI) were calculated. Of the 1387 potentially eligible articles, nine case series with high risk of bias could be included. The pooled sensitivity was 0.97 (95% CI 0.87, 0.99). Specificity was 0.91 (95% CI 0.83, 0.95). For clinical practice, no recommendation can be made regarding the use of hip injections for diagnosing hip OA. High quality, accurately reported studies are needed to provide better evidence on the diagnostic role of hip injection.

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.

Defining discriminative pain trajectories in hip osteoarthritis over a 2-year time period.

BACKGROUND: Although pain due to osteoarthritis (OA) generally deteriorates over time, there is a large individual variation in the course of pain. This study examines the different longitudinal trajectories of patients with hip pain due to OA. METHODS: Data from a previously performed randomised controlled trial were used to investigate the course of pain over 2 years in 222 patients with clinically and radiographically determined hip OA. Pain was measured with a visual analogue scale (0-100). Latent class growth analysis was used to determine the number of trajectories of patients with hip pain due to OA. RESULTS: Analyses yielded five trajectories of pain due to hip OA. Trajectory 1 ('mild pain'; n=69) consists of patients with stable mild pain. Patients in trajectory 2 ('moderate pain'; n=31) fluctuated slightly between moderate and severe pain levels. Trajectory 3 ('always pain'; n=32) consists of patients with severe pain. Patients in trajectory 4 ('regularly progressing'; n=48) started with mild pain and progressed slowly to moderate pain. Trajectory 5 ('highly progressing'; n=42) patients also started with mild pain but quickly progressed to severe pain over 2 years. Compared with the 'mild pain' group, patients in the 'always pain' group had more severe radiographic hip OA, morning stiffness and decreased range of motion. The 'highly progressing' group had more severe radiographic hip OA and morning stiffness. CONCLUSIONS: Latent class growth analysis applied to longitudinal data of patients with hip OA identified five distinct trajectories of pain. More studies are needed to externally validate these findings.

Determinants of (sustained) overweight and complaints in children and adolescents in primary care: the DOERAK cohort study design.

BACKGROUND: Almost half of the adult Dutch population is currently overweight and the prevalence of overweight children is rising at alarming rates as well. Obese children consult their general practitioner (GP) more often than normal weight children. The Dutch government has assigned a key role to the GP in the prevention of overweight.The DOERAK cohort study aims to clarify differences between overweight and non-overweight children that consult the GP; are there differences in number of consultations and type and course of complaints? Is overweight associated with lower quality of life or might this be influenced by the type of complaint? What is the activity level of overweight children compared to non-overweight children? And is (sustained) overweight of children associated with parameters related to the energy balance equation? METHODS/DESIGN: A total of 2000 overweight (n = 500) and non-overweight children (n = 1500) aged 2 to 18 years who consult their GP, for any type of complaint in the South-West of the Netherlands are included.At baseline, height, weight and waist circumference are measured during consultation. The number of GP consultations over the last twelve months and accompanying diagnoses are acquired from the medical file. Complaints, quality of life and parameters related to the energy balance equation are assessed with an online questionnaire children or parents fill out at home. Additionally, children or parents keep a physical activity diary during the baseline week, which is validated in a subsample (n = 100) with an activity monitor. Parents fill out a questionnaire about demographics, their own activity behaviour and perceptions on dietary habits and activity behaviour, health and weight status of their child. The physical and lifestyle behaviour questions are repeated at 6, 12 and 24 months follow-up. The present study is a prospective observational cohort in a primary care setting. DISCUSSION: The DOERAK cohort study is the first prospective study that investigates a large cohort of overweight and non-overweight children in primary care. The total study population is expected to be recruited by 2013, results will be available in 2015.

Course and prognosis of recovery for chronic non-specific low back pain: design, therapy program and baseline data of a prospective cohort study.

BACKGROUND: There has been increasing focus on factors predicting the development of chronic musculoskeletal disorders. For patients already experiencing chronic non-specific low back pain it is also relevant to investigate which prognostic factors predict recovery. We present the design of a cohort study that aims to determine the course and prognostic factors for recovery in patients with chronic non-specific low back pain. METHODS/DESIGN: All participating patients were recruited (Jan 2003-Dec 2008) from the same rehabilitation centre and were evaluated by means of (postal) questionnaires and physical examinations at baseline, during the 2-month therapy program, and at 5 and 12 months after start of therapy. The therapy protocol at the rehabilitation centre used a bio-psychosocial approach to stimulate patients to adopt adequate (movement) behaviour aimed at physical and functional recovery. The program is part of regular care and consists of 16 sessions of 3 hours each, over an 8-week period (in total 48 hours), followed by a 3-month self-management program. The primary outcomes are low back pain intensity, disability, quality of life, patient's global perceived effect of recovery, and participation in work. Baseline characteristics include information on socio-demographics, low back pain, employment status, and additional clinical items status such as fatigue, duration of activities, and fear of kinesiophobia. Prognostic variables are determined for recovery at short-term (5 months) and long-term (12 months) follow-up after start of therapy. DISCUSSION: In a routine clinical setting it is important to provide patients suffering from chronic non-specific low back pain with adequate information about the prognosis of their complaint.

Design of the Verbiest trial: cost-effectiveness of surgery versus prolonged conservative treatment in patients with lumbar stenosis.

BACKGROUND: Degenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However the natural course is not necessarily progressive and the efficacy of a variety of nonsurgical interventions has also been described. At present there is insufficient data to compare surgical and nonsurgical interventions in terms of their relative benefit and safety. Previous attempts failed to provide clear clinical recommendations or to distinguish subgroups that substantially benefit from a certain treatment strategy. We present the design of a randomized controlled trial on (cost-) effectiveness of surgical decompression versus prolonged conservative treatment in patients with neurogenic intermittent claudication caused by lumbar stenosis. METHODS/DESIGN: The aim of the Verbiest trial is to evaluate the effectiveness of prolonged conservative treatment compared to decompressive surgery. The study is a multi-center randomized controlled trial with two parallel groups design. Patients (age over 50) presenting to the neurologist or neurosurgeon with at least 3 months complaints of neurogenic intermittent claudication and considering surgical treatment are eligible for inclusion. Participants are randomly allocated to either prolonged conservative treatment, receiving further treatment from their general practitioner and physical therapist, or allocated to surgery and operated within 4 weeks. Primary outcome measure is the functional assessment of the patient as measured by the Zurich Claudication Questionnaire at 24 months of follow-up. Data is analyzed according to the intention to treat principle. DISCUSSION: With a cost-effectiveness analysis the trade off between the costs of prolonged conservative treatment and delayed surgery in a smaller number of patients are compared with the current policy of surgical management. As surgery is expected to be inevitable in certain subgroups of patients, the distinction of and classification by predictive patient characteristics is most relevant to clinical practice. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2216.

Cost-effectiveness of exercise therapy versus general practitioner care for osteoarthritis of the hip: design of a randomised clinical trial.

BACKGROUND: Osteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA. METHODS/DESIGN: Patients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed. DISCUSSION: The results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry http://www.trialregister.nl: trial number NTR1462.

Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial.

BACKGROUND: Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed.The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication. METHODS/DESIGN: This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years) with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline) injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics). Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle. DISCUSSION: This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started. TRIAL REGISTRATION: This trial is registered in the Dutch Trial Registry: number NTR2966.