Prognosis of persistent complaints after knee injury is based on secondary care populations. In a primary care setting, however, no studies have addressed this issue.
To identify possible predictors of persistent complaints 1 year after a knee injury. These predictors are important for guiding the GP’s therapeutic management, and giving advice to patients about work and/or sports-related activities.
Design and setting
Primary care prospective cohort study with a 1-year follow-up period in five municipalities in the southwest region of the Netherlands.
Patients who were eligible were recruited to the study by a GP research network with around 84 000 patients and 40 participating GPs. A total of 134 patients (aged 18–65 years) who consulted their GP within 5 weeks after a knee injury entered the study. Follow-up after 1 year was conducted in 122 patients. The main outcome was persistent complaints 1 year after injury; possible predictors for these complaints were obtained with a questionnaire, a physical examination, and magnetic resonance imaging (MRI), according to a standardised protocol.
After 1 year, of the 122 available patients, 21 (17%) reported persistent complaints and 101 (83%) reported full recovery or major improvement. In this study being aged >40 years had a significant association (P<0.05) with persistent complaints (odds ratio 8.0, 95% confidence interval 2.1 to 30.5). Physical examination and MRI findings revealed no predictors that were associated with these complaints.
Being aged >40 years was the only determinant with a significant association with persistent complaints. As physical examination and MRI had no predictive value, they are not recommended for prognosis of persistent complaints.
general practice; knee injury; prognosis
Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica.
PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant’s optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives.
This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica.
ClinicalTrial.gov, ACTRN 12613000530729
Sciatica; Pregabalin; Neuropathic pain; Randomised control trial
Previous reviews of randomised controlled trials (RCTs) for low-back pain (LBP) have failed to identify any positive trend in study quality with more recent years of publication. This study aimed to identify and describe trends over time in the study design characteristics and risk of bias in chronic LBP trials performed over the past 30 years.
One fifty-seven randomised trials of interventions for chronic LBP were extracted from recently published systematic reviews. The reviews included RCTs on physical and rehabilitation interventions, injection therapy and denervation procedures, complementary and alternative therapies and pharmacological interventions for chronic LBP. Study level data were extracted and analysed for trends associated with year of publication.
Overall, the mean sample size in the RCTs was 141 (median 70; range 17–3093). There was a slight increase in the median number of risk of bias criteria fulfilled from trials published prior to 1995 to those published after 1996. The analysis showed that in more recent years RCTs of medical interventions were more likely to be successfully blinded than RCTs of non-medical interventions.
The continuing uncertainty regarding the efficacy of many interventions for chronic LBP again stresses the need for large RCTs with low risk of bias. Further research is needed into specific risks of bias within the RCTs for chronic LBP and the effect they have on the plausibility of the results.
Back pain; Bias; Methodology; Randomised trials
In about 5% of all cases LBP is associated with serious underlying pathology requiring diagnostic confirmation and directed treatment. Magnetic resonance imaging (MRI) is often used for this diagnostic purpose yet its role remains controversial. Consequently, this review aimed to summarize the available evidence on the diagnostic accuracy of MRI for identifying lumbar spinal pathology in adult low back pain (LPB) or sciatica patients.
MEDLINE, EMBASE and CINAHL were searched (until December 2009) for observational studies assessing the diagnostic accuracy of MRI compared to a reference test for the identification of lumbar spinal pathology. Two reviewers independently selected studies for inclusion, extracted data and assessed methodological quality. Pooled summary estimates of sensitivity and specificity with 95% confidence intervals were calculated for homogenous subsets of studies.
Eight studies were included in this review. Strata were defined for separate pathologies i.e. lumbar disc herniation (HNP) and spinal stenosis. Five studies comparing MRI to findings at the surgery for identifying HNP were included in a meta-analysis. Pooled analysis resulted in a summary estimate of sensitivity of 75% (95% CI 65–83%) and specificity of 77% (95% CI 61–88%). For spinal stenosis pooling was not possible.
The results suggest that a considerable proportion of patients may be classified incorrectly by MRI for HNP and spinal stenosis. However, the evidence for the diagnostic accuracy of MRI found by this review is not conclusive, since the results could be distorted due to the limited number of studies and large heterogeneity.
Diagnostic accuracy; Systematic review; MRI; Low back pain; Diagnostic imaging
Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic.
All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a Randomized Controlled Trial (RCT). For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires.
No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study.
Trial registration number
National Trial Register: NTR3531
Chronic mechanical low back pain; Minimal interventional procedures; Multidisciplinary pain programme; Economic evaluation
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?
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.
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.
Disc herniation with sciatica accounts for five percent of low-back disorders but is one of the most common reasons for spine surgery. The goal of this study was to update the Cochrane review on the effect of surgical techniques for sciatica due to disc herniation, which was last updated in 2007.
Materials and methods
In April 2011, we conducted a comprehensive search in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDRO, ICL, and trial registries. We also checked the reference lists and citation tracking results of each retrieved article. Only randomized controlled trials (RCT) of the surgical management of sciatica due to disc herniation were included. Comparisons including chemonucleolysis and prevention of scar tissue or comparisons against conservative treatment were excluded. Two review authors independently selected studies, assessed risk of bias of the studies and extracted data. Quality of evidence was graded according to the GRADE approach.
Seven studies from the original Cochrane review were included and nine additional studies were found. In total, 16 studies were included, of which four had a low risk of bias. Studies showed that microscopic discectomy results in a significantly, but not clinically relevant longer operation time of 12 min (95 % CI 2–22) and shorter incision of 24 mm (95 % CI 7–40) compared with open discectomy, but did not find any clinically relevant superiority of either technique on clinical results. There were conflicting results regarding the comparison of tubular discectomy versus microscopic discectomy for back pain and surgical duration.
Due to the limited amount and quality of evidence, no firm conclusions on effectiveness of the current surgical techniques being open discectomy, microscopic discectomy, and tubular discectomy compared with each other can be drawn. Those differences in leg or back pain scores, operation time, and incision length that were found are clinically insignificant. Large, high-quality studies are needed, which examine not only effectiveness but cost-effectiveness as well.
Herniated disc; Sciatica; Surgery; Discectomy; Systematic review
To investigate the course of mental health problems in children presenting to general practice with abdominal pain and to evaluate the extent to which abdominal pain characteristics during follow-up predict the presence of mental health problems at 12 months’ follow-up.
A prospective cohort study with one-year follow-up.
53 general practices in the Netherlands, between May 2004 and March 2006.
281 children aged 4–17 years.
Main outcome measures
The presence of a depressive problem, an anxiety problem, and multiple non-specific somatic symptoms at follow-up and odds ratios of duration, frequency, and severity of abdominal pain with these mental health problems at follow-up.
A depressive problem persisted in 24/74 children (32.9%; 95% CI 22.3–44.9%), an anxiety problem in 13/43 (30.2%; 95% CI 17.2–46.1%) and the presence of multiple non-specific somatic symptoms in 75/170 children (44.1%; 95% CI 36.7–51.6%). None of the abdominal pain characteristics predicted a depressive or an anxiety problem at 12 months’ follow-up. More moments of moderate to severe abdominal pain predicted the presence of multiple non-specific somatic symptoms at follow-up.
In one-third of the children presenting to general practice for abdominal pain, anxiety and depressive problems persist during one year of follow-up. Characteristics of the abdominal pain during the follow-up period do not predict anxiety or depressive problems after one-year follow-up. We recommend following over time children seen in primary care with abdominal pain.
Abdominal pain; adolescent; child; cohort study; family practice; mental disorders; prognosis
Most research on risk factors for low back pain has focused on long term exposures rather than factors immediately preceding the onset of low back pain. The aim of this study is to quantify the transient increase in risk of a sudden episode of low back pain associated with acute exposure to a range of common physical and psychological factors.
This study uses a case-crossover design. One thousand adults with a sudden onset of low back pain presenting to primary care clinicians will be recruited. Basic demographic and clinical information including exposure to putative triggers will be collected using a questionnaire. These triggers include exposure to hazardous manual tasks, physical activity, a slip/trip or fall, consumption of alcohol, sexual activity, being distracted, and being fatigued or tired. Exposures in the case window (0-2 hours from the time when participants first notice their back pain) will be compared to exposures in two control time-windows (one 24-26 hours and another 48-50 hours before the case window).
The completion of this study will provide the first-research based estimates of the increase in risk of a sudden episode of acute low back pain associated with transient exposure to a range of common factors thought to trigger low back pain.
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.
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.
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.
In low back pain if serious pathology is suspected diagnostic imaging could be performed. One of the imaging techniques available for this purpose is computed tomography (CT), however, insight in the diagnostic performance of CT is unclear.
Diagnostic systematic review. Studies assessing the diagnostic accuracy of CT in adult patients suggested having low back pain caused by specific pathology were selected. Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias. Pooled summary estimates of sensitivity and specificity with 95% CI were calculated.
Seven studies were included, all describing the diagnostic accuracy of CT in identifying lumbar disc herniation. Six studies used surgical findings as the reference standard and were considered sufficiently homogenous to carry out a meta-analysis. The pooled summary estimate of sensitivity was 77.4% and specificity was 73.7%.
We found no studies evaluating the accuracy of CT for pathologies such as vertebral cancer, infection and fractures and this remains unclear. Our results should be interpreted with some caution. Sensitivity and specificity, regarding the detection of lumbar disc herniation, showed that a substantial part of the patients is still classified as false-negative and false-positive. In future, the diagnostic performance of CT must be assessed in high quality prospective cohort studies with an unselected population of patients with low back pain.
Computed tomography; Low back pain; Diagnostic imaging; Systematic review
To critically appraise and compare the measurement properties of the original versions of neck-specific questionnaires.
Bibliographic databases were searched for articles concerning the development or evaluation of the measurement properties of an original version of a self-reported questionnaire, evaluating pain and/or disability, which was specifically developed or adapted for patients with neck pain. The methodological quality of the selected studies and the results of the measurement properties were critically appraised and rated using a checklist, specifically designed for evaluating studies on measurement properties.
The search strategy resulted in a total of 3,641 unique hits, of which 25 articles, evaluating 8 different questionnaires, were included in our study. The Neck Disability Index is the most frequently evaluated questionnaire and shows positive results for internal consistency, content validity, structural validity, hypothesis testing, and responsiveness, but a negative result for reliability. The other questionnaires show positive results, but the evidence for each measurement property is mostly limited, and at least 50% of the information on measurement properties per questionnaire is lacking.
Our findings imply that studies of high methodological quality are needed to properly assess the measurement properties of the currently available questionnaires. Until high quality studies are available, we recommend using these questionnaires with caution. There is no need for the development of new neck-specific questionnaires until the current questionnaires have been adequately assessed.
Neck pain; Neck disability; Questionnaire; Pain measurement; Validation studies; Reproducibility of results; Psychometrics; Systematic review
Several disease-specific questionnaires to measure pain and disability in patients with neck pain have been translated. However, a simple translation of the original version doesn't guarantee similar measurement properties. The objective of this study is to critically appraise the quality of the translation process, cross-cultural validation and the measurement properties of translated versions of neck-specific questionnaires.
Bibliographic databases were searched for articles concerning the translation or evaluation of the measurement properties of a translated version of a neck-specific questionnaire. The methodological quality of the selected studies and the results of the measurement properties were critically appraised and rated using the COSMIN checklist and criteria for measurement properties.
The search strategy resulted in a total of 3641 unique hits, of which 27 articles, evaluating 6 different questionnaires in 15 different languages, were included in this study. Generally the methodological quality of the translation process is poor and none of the included studies performed a cross-cultural adaptation. A substantial amount of information regarding the measurement properties of translated versions of the different neck-specific questionnaires is lacking. Moreover, the evidence for the quality of measurement properties of the translated versions is mostly limited or assessed in studies of poor methodological quality.
Until results from high quality studies are available, we advise to use the Catalan, Dutch, English, Iranian, Korean, Spanish and Turkish version of the NDI, the Chinese version of the NPQ, and the Finnish, German and Italian version of the NPDS. The Greek NDI needs cross-cultural validation and there is no methodologically sound information for the Swedish NDI. For all other languages we advise to translate the original version of the NDI.
Parents of febrile children frequently contact primary care. Longer duration of fever has been related to increased risk for serious bacterial infections (SBI). However, the evidence for this association remains controversial. We assessed the predictive value of duration of fever for SBI.
Studies from MEDLINE, Embase and Cochrane databases (from January 1991 to December 2009) were retrieved. We included studies describing children aged 2 months to 6 years in countries with high Haemophilus influenzae type b vaccination coverage. Duration of fever had to be studied as a predictor for serious bacterial infections.
Seven studies assessed the association between duration of fever and serious bacterial infections; three of these found a relationship.
The predictive value of duration of fever for identifying serious bacterial infections in children remains inconclusive. None of these seven studies was performed in primary care. Studies evaluating the duration of fever and its predictive value in children in primary care are required.
To develop a prediction model that predicts disability in community-dwelling older people. Insight in the predictors of disability is needed to target preventive strategies for people at increased risk.
Data were obtained from the Rotterdam Study, including subjects of 55 years and over. Subjects who had complete data for sociodemographic factors, life style variables, health conditions, disability status at baseline and complete data for disability at follow-up were included in the analysis. Disability was expressed as a Disability Index (DI) measured with the Health Assessment Questionnaire.
We used a multivariable polytomous logistic regression to derive a basic prediction model and an extended prediction model. Finally we developed readily applicable score charts for the calculation of outcome probabilities.
Of the 5027 subjects included, 49% had no disability, 18% had mild disability, 16% had severe disability and 18% had deceased at follow-up after six years. The strongest predictors were age and prior disability. The contribution of other predictors was relatively small. The discriminative ability of the basic model was high; the extended model did not enhance predictive ability.
As prior disability status predicts future disability status, interventive strategies should be aimed at preventing disability in the first place.
disability; older people; prediction model; prospective cohort
To prospectively evaluate prognostic factors for new onset or progression of degenerative change on follow-up MRI one year after knee trauma and the association with clinical outcome.
Within a prospective observational cohort study in general practice, we studied a subgroup of 117 patients with acute knee trauma (mean age 41 years, 43% women). Degenerative change was scored on MRI at baseline and after one year follow-up. Multivariate logistic regression analysis was performed to evaluate prognostic factors for new onset or progressive degenerative change on follow-up MRI. Association between new or progressive degeneration and clinical outcome after one year was assessed.
On follow-up MRI 15% of patients with pre-existing knee osteoarthritis showed progression and 26% of patients demonstrated new degenerative change. The only statistically significant prognostic variable in the multivariate analysis was bone marrow oedema on initial MRI (OR 5.29 (95% CI 1.64–17.1), p = 0.005). A significant association between new or progressive degenerative change and clinical outcome was found (p = 0.003).
Bone marrow oedema on MRI for acute knee injury is strongly predictive of new onset or progression of degenerative change of the femorotibial joint on follow-up MRI one year after trauma, which is reflected in clinical outcome.
Knee injury; Osteoarthritis; MRI; Follow-up; Clinical outcome
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.
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.
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.
Netherlands Trial Register (NTR): NTR2216
Knee injuries may lead to pain and to functional limitations in the activities of daily living. Patients with knee injuries are frequently seen in general practice; however, the outcome and management in these patients is not known.
To assess the outcome and management of knee injuries at 12 months' follow-up in general practice.
Design of study
A prospective observational cohort study with a 1-year follow-up.
Primary health care.
Adult patients consulting their GP after knee injury (n = 134) participated in the cohort. A magnetic resonance imaging scan was carried out and patients were diagnosed as either no lesion or an isolated meniscal tear, an isolated collateral or cruciate ligament lesion, or a combination. Follow-up questionnaires were filled in up to 12 months' follow-up.
At 12 months' follow-up, 34 patients reported full recovery and 67 patients reported major improvement. At baseline, 37 patients (28%) were referred to physical therapy and 17 patients (13%) were referred to secondary care. During 1 year of follow-up, another 21 referrals to physical therapy and 11 referrals to secondary care took place. The pain severity decreased the most, and the Lysholm knee score increased in the majority of patients during the first 3 months after injury. In total, 18 arthroscopies were performed in 15 patients. One patient underwent an anterior cruciate ligament reconstruction.
The vast majority of patients report clinically relevant recovery. There is no clear difference in outcomes between patients with meniscal tears or ligament lesions and patients without these diagnoses.
family practice; knee injuries; outcome studies
Objective To summarise the effectiveness of adding supervised exercises to conventional treatment compared with conventional treatment alone in patients with acute lateral ankle sprains.
Design Systematic review.
Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, Cinahl, and reference screening.
Study selection Included studies were randomised controlled trials, quasi-randomised controlled trials, or clinical trials. Patients were adolescents or adults with an acute lateral ankle sprain. The treatment options were conventional treatment alone or conventional treatment combined with supervised exercises. Two reviewers independently assessed the risk of bias, and one reviewer extracted data. Because of clinical heterogeneity we analysed the data using a best evidence synthesis. Follow-up was classified as short term (up to two weeks), intermediate (two weeks to three months), and long term (more than three months).
Results 11 studies were included. There was limited to moderate evidence to suggest that the addition of supervised exercises to conventional treatment leads to faster and better recovery and a faster return to sport at short term follow-up than conventional treatment alone. In specific populations (athletes, soldiers, and patients with severe injuries) this evidence was restricted to a faster return to work and sport only. There was no strong evidence of effectiveness for any of the outcome measures. Most of the included studies had a high risk of bias, with few having adequate statistical power to detect clinically relevant differences.
Conclusion Additional supervised exercises compared with conventional treatment alone have some benefit for recovery and return to sport in patients with ankle sprain, though the evidence is limited or moderate and many studies are subject to bias.
Cryotherapy is widely used for the treatment of cutaneous warts in primary care. However, evidence favours salicylic acid application. We compared the effectiveness of these treatments as well as a wait-and-see approach.
Consecutive patients with new cutaneous warts were recruited in 30 primary care practices in the Netherlands between May 1, 2006, and Jan. 26, 2007. We randomly allocated eligible patients to one of three groups: cryotherapy with liquid nitrogen every two weeks, self-application of salicylic acid daily or a wait-and-see approach. The primary outcome was the proportion of participants whose warts were all cured at 13 weeks. Analysis was on an intention-to-treat basis. Secondary outcomes included treatment adherence, side effects and treatment satisfaction. Research nurses assessed outcomes during home visits at 4, 13 and 26 weeks.
Of the 250 participants (age 4 to 79 years), 240 were included in the analysis at 13 weeks (loss to follow-up 4%). Cure rates were 39% (95% confidence interval [CI] 29%–51%) in the cryotherapy group, 24% (95% CI 16%–35%) in the salicylic acid group and 16% (95% CI 9.5%–25%) in the wait-and-see group. Differences in effectiveness were most pronounced among participants with common warts (n = 116): cure rates were 49% (95% CI 34%–64%) in the cryotherapy group, 15% (95% CI 7%–30%) in the salicylic acid group and 8% (95% CI 3%–21%) in the wait-and-see group. Cure rates among the participants with plantar warts (n = 124) did not differ significantly between treatment groups.
For common warts, cryotherapy was the most effective therapy in primary care. For plantar warts, we found no clinically relevant difference in effectiveness between cryotherapy, topical application of salicylic acid or a wait-and-see approach after 13 weeks. (ClinicalTrial.gov registration no. ISRCTN42730629)
To estimate the occurrence and type of adverse effects after application of an extra-articular (soft tissue) corticosteroid injection.
A systematic review of the literature was made based on a PubMed and Embase search covering the period 1956 to January 2010. Case reports were included, as were prospective and retrospective studies that reported adverse events of corticosteroid injection. All clinical trials which used extra-articular corticosteroid injections were examined. We divided the reported adverse events into major (defined as those needing intervention or not disappearing) and minor ones (transient, not requiring intervention).
The search yielded 87 relevant studies:44 case reports, 37 prospective studies and 6 retrospective studies. The major adverse events included osteomyelitis and protothecosis; one fatal necrotizing fasciitis; cellulitis and ecchymosis; tendon ruptures; atrophy of the plantar fat was described after injecting a neuroma; and local skin effects appeared as atrophy, hypopigmentation or as skin defect. The minor adverse events effects ranged from skin rash to flushing and disturbed menstrual pattern. Increased pain or steroid flare after injection was reported in 19 studies. After extra-articular injection, the incidence of major adverse events ranged from 0-5.8% and that of minor adverse events from 0-81%. It was not feasible to pool the risk for adverse effects due to heterogeneity of study populations and difference in interventions and variance in reporting.
In this literature review it was difficult to accurately quantify the incidence of adverse effects after extra-articular corticosteroid injection. The reported adverse events were relatively mild, although one fatal reaction was reported.
Low back pain (LBP) is a common and disabling disorder in western society. The management of LBP comprises a range of different intervention strategies including surgery, drug therapy, and non-medical interventions. The objective of the present study is to determine the effectiveness of physical and rehabilitation interventions (i.e. exercise therapy, back school, transcutaneous electrical nerve stimulation (TENS), low level laser therapy, education, massage, behavioural treatment, traction, multidisciplinary treatment, lumbar supports, and heat/cold therapy) for chronic LBP. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to 22 December 2008. Existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria. The search strategy outlined by the Cochrane Back Review Groups (CBRG) was followed. The following were included for selection criteria: (1) randomized controlled trials, (2) adult (≥18 years) population with chronic (≥12 weeks) non-specific LBP, and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias, and outcomes at short, intermediate, and long-term follow-up. The GRADE approach was used to determine the quality of evidence. In total 83 randomized controlled trials met the inclusion criteria: exercise therapy (n = 37), back school (n = 5), TENS (n = 6), low level laser therapy (n = 3), behavioural treatment (n = 21), patient education (n = 1), traction (n = 1), and multidisciplinary treatment (n = 6). Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. Behavioural treatment was found to be effective in reducing pain intensity at short-term follow-up compared to no treatment/waiting list controls. Finally, multidisciplinary treatment was found to reduce pain intensity and disability at short-term follow-up compared to no treatment/waiting list controls. Overall, the level of evidence was low. Evidence from randomized controlled trials demonstrates that there is low quality evidence for the effectiveness of exercise therapy compared to usual care, there is low evidence for the effectiveness of behavioural therapy compared to no treatment and there is moderate evidence for the effectiveness of a multidisciplinary treatment compared to no treatment and other active treatments at reducing pain at short-term in the treatment of chronic low back pain. Based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusion on the clinical effect of back schools, low-level laser therapy, patient education, massage, traction, superficial heat/cold, and lumbar supports for chronic LBP.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-010-1518-3) contains supplementary material, which is available to authorized users.
Systematic review; Exercise; Back school; TENS; Education; Multidisciplinary; Behavioural; Effectiveness of interventions; Efficacy; Low back pain; Meta-analyses; Treatment effects; Rehabilitation; Conservative
The aim of this study was to present and compare the content of (inter)national clinical guidelines for the management of low back pain. To rationalise the management of low back pain, evidence-based clinical guidelines have been issued in many countries. Given that the available scientific evidence is the same, irrespective of the country, one would expect these guidelines to include more or less similar recommendations regarding diagnosis and treatment. We updated a previous review that included clinical guidelines published up to and including the year 2000. Guidelines were included that met the following criteria: the target group consisted mainly of primary health care professionals, and the guideline was published in English, German, Finnish, Spanish, Norwegian, or Dutch. Only one guideline per country was included: the one most recently published. This updated review includes national clinical guidelines from 13 countries and 2 international clinical guidelines from Europe published from 2000 until 2008. The content of the guidelines appeared to be quite similar regarding the diagnostic classification (diagnostic triage) and the use of diagnostic and therapeutic interventions. Consistent features for acute low back pain were the early and gradual activation of patients, the discouragement of prescribed bed rest and the recognition of psychosocial factors as risk factors for chronicity. For chronic low back pain, consistent features included supervised exercises, cognitive behavioural therapy and multidisciplinary treatment. However, there are some discrepancies for recommendations regarding spinal manipulation and drug treatment for acute and chronic low back pain. The comparison of international clinical guidelines for the management of low back pain showed that diagnostic and therapeutic recommendations are generally similar. There are also some differences which may be due to a lack of strong evidence regarding these topics or due to differences in local health care systems. The implementation of these clinical guidelines remains a challenge for clinical practice and research.
Low back pain; Clinical guidelines; Review; Diagnosis; Treatment
Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation.
Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years.
Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial.
Netherlands Trial Register NTR1289
Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis.
Patients (age 40-85) presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ), at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year.
Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial.
Dutch Trial register number: NTR1307