Rob J. P. M. Scholten

Manual therapy, physical therapy, or continued care by a general practitioner for patients with neck pain. A randomized, controlled trial.

Context Neck pain is common among primary care patients. Evidence on the effectiveness of therapies for neck pain is limited. A previous randomized, controlled trial suggested benefits from manual therapy and physical therapy. Contribution This randomized, controlled trial of manual therapy, physical therapy, and continued care by a doctor confirms the superiority of manual therapy and physical therapy over continued care. At 7 weeks, 68.3% of patients in the manual therapy group reported resolved or much improved pain, compared with 50.8% of patients in the physical therapy group and 35.9% of patients in the continued care group. Clinical Implications Primary care physicians should consider manual therapy when treating patients with neck pain. The Editors Neck pain is a common problem in the general population, with point prevalences between 10% and 15% (1-3). It is most common at approximately 50 years of age and is more common in women than in men (1, 2, 4-6). Neck pain can be severely disabling and costly, and little is known about its clinical course (7-9). Limited range of motion and a subjective feeling of stiffness may accompany neck pain, which is often precipitated or aggravated by neck movements or sustained neck postures. Headache, brachialgia, dizziness, and other signs and symptoms may also be present in combination with neck pain (10, 11). Although history taking and diagnostic examination can suggest a potential cause, in most cases the pathologic basis for neck pain is unclear and the pain is labeled nonspecific. Conservative treatment methods that are frequently used in general practice include analgesics, rest, or referral to a physical therapist or manual therapist (12, 13). Physical therapy may include passive treatment, such as massage, interferential current, or heat applications, and active treatment, such as exercise therapies. Physical therapists can specialize in passive manual (or hands-on) techniques, including mobilization or manipulation (high-velocity thrust techniques), also referred to as manual therapy (14-19). According to the International Federation of Orthopedic Manipulative Therapies, Orthopedic manipulative (manual) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other symptoms of neuro-musculo-articular dysfunction in the spine and extremities (unpublished data). Today, many different manual therapy approaches are applied by various health professionals, including medical doctors, physical therapists, massage therapists, manual therapists, chiropractors, and osteopathic doctors. Reviews of trials involving manual therapy or physical therapy show that most interventions in these categories are characterized by a combination of passive and active components (20-23). Although a combination of manual therapy or physical therapy that includes exercises appears to be effective for neck pain, these therapies have not been studied in sufficient detail to draw firm conclusions, and the methodologic quality of most trials on neck pain is rather low (20-23). Koes and colleagues (24, 25) performed a randomized trial on back and neck pain and found promising results for manual therapy and physical therapy in subgroup analyses of patients with neck pain. In our randomized, controlled trial, we compared the effectiveness of manual therapy, physical therapy, and continued care by a general practitioner in patients with nonspecific neck pain. Methods Patients Patients with nonspecific neck pain whose clinical presentation did not warrant referral for further diagnostic screening were referred to one of four research centers by 42 general practitioners for study selection. We excluded patients whose history, signs, and symptoms suggested a potential nonbenign cause (including previous surgery of the neck) or evidence of a specific pathologic condition, such as malignancy, neurologic disease, fracture, herniated disc, or systemic rheumatic disease. Two research assistants who were experienced physical therapists and were blinded to treatment allocation performed physical examinations at baseline and follow-up. They used standardized inclusion and exclusion criteria and performed a short neurologic examination (Appendix Table 1) and range-of-motion assessment. The eligibility criteria were age between 18 and 70 years, pain or stiffness in the neck for at least 2 weeks, neck symptoms reproducible during physical examination, willingness to adhere to treatment and measurement regimens, no physical therapy or manual therapy for neck pain during the previous 6 months, no involvement in litigation, and written informed consent. Patients with concurrent headaches, nonradicular pain in the upper extremities, and low back pain were not excluded, but neck pain had to be the main symptom for all patients. Random Assignment and Data Collection All patient data were collected before randomization. Patients were assigned to a treatment group on the basis of block randomization after prestratification for symptom severity (severity scores <7 points or 7 points on a scale of 0 to 10); age (<40 years or 40 years); and, mainly for practical reasons, research center (four local centers). Randomized permuted blocks of six patients were generated for each stratum by using a computer-generated random-sequence table. A researcher who was not involved in the project prepared opaque, sequentially numbered sealed envelopes that contained folded cards indicating one of the three interventions. Interventions The intervention period lasted 6 weeks. Patients were allowed to perform exercises at home and to continue medication prescribed at baseline or use over-the-counter analgesics. Other co-interventions were discouraged but were registered if they occurred. Within the boundaries of the protocol, treatment could be reassessed and adapted to the patients condition. The specific treatment characteristics were registered at each visit. A maximum number of visits was set for each intervention group; however, the patients did not have to complete this maximum number if symptoms had resolved. Manual Therapy Our approach to manual therapy was eclectic and incorporated several techniques used in western Europe, North America, and Australia, including those described by Cyriax, Kaltenborn, Maitland, and Mennel (15, 16, 19). In our trial, manual therapy (defined as the use of passive movements to help restore normal spinal function) included hands-on muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature) (26). Joint mobilization is a form of manual therapy that involves low-velocity passive movements within or at the limit of joint range of motion (27). Manual therapists must undergo extensive training to be able to skillfully perform mobilization techniques (15, 19). Spinal manipulations (low-amplitude, high-velocity thrust techniques) were not included in this protocol. Forty-five minute treatment sessions were scheduled once per week, for a maximum of six treatments. Six experienced manual therapists acknowledged by the Netherlands Manual Therapy Association performed the treatment. Physical Therapy The physical therapists used a combination of several treatment options, but active exercise therapies were the cornerstone of their strategy. Active exercise therapy involves participation by the patient and includes active exercises (to improve strength or range of motion), postural exercises, stretching, relaxation exercises, and functional exercises. Manual traction or stretching, massage, or physical therapy methods, such as interferential current or heat applications, could precede the exercise therapy. Specific manual mobilization techniques were not included in this protocol. Thirty-minute treatment sessions were scheduled twice per week for a maximum of 12 treatments. The treatment was performed by five experienced physical therapists. We prevented cross-contamination with manual therapy by choosing physical therapists who were not manual therapy specialists. Continued Care by a General Practitioner Each patient in this group received standardized care from his or her general practitioner, including advice on prognosis, advice on psychosocial issues, advice on self-care (heat application, home exercises), advice on ergonomics (for example, size of pillow, work position), and encouragement to await further recovery. The treatment protocol was similar to the practice guidelines for low back pain issued by the Dutch College of General Practitioners (28). Patients received an educational booklet containing ergonomic advice and exercises (29). Medication, including paracetamol or nonsteroidal anti-inflammatory drugs, was prescribed on a time-contingent basis if necessary. Ten-minute follow-up visits, scheduled every 2 weeks, were optional, and referral during the intervention period was discouraged. Outcome Measures Data were collected at the research center after 3 and 7 weeks. At 7 weeks, treatment results were expected to be maximal. The patients were repeatedly asked not to reveal any information about their treatment allocation to the research assistants. The success of blinding was evaluated at 7 weeks. Primary outcome measures focused on perceived recovery, pain, and functional disability. Patients rated perceived recovery on a 6-point ordinal transition scale, ranging from much worse to completely recovered. Success was defined a priori as completely recovered or much improved (30). In addition, on the basis of the systematic assessment of spinal mobility, palpation, and pain reported by the

Conservative treatment options for carpal tunnel syndrome: a systematic review of randomised controlled trials

Abstract Carpal tunnel syndrome (CTS) is a common disorder, for which various conservative treatment options are available. The objective of this study is to determine the efficacy of the various conservative treatment options for relieving the symptoms of CTS. Computer-aided searches of MEDLINE (1/1966 to 3/2000), EMBASE (1/1988 to 2/2000) and the Cochrane Controlled Trials Register (2000, issue 1) were conducted, together with reference checking. Included were randomised controlled trials evaluating the efficacy of conservative treatment options in a study population of CTS patients, with a full report published in English, German, French or Dutch. Two reviewers independently selected the studies. Fourteen randomised controlled trials were included in the review. Assessment of methodological quality and data-extraction was independently performed by two reviewers. A rating system, based on the number of studies and their methodological quality and findings, was used to determine the strength of the available evidence for the efficacy of the treatment. Diuretics, pyridoxine, non-steroidal anti-inflammatory drugs, yoga and laser-acupuncture seem to be ineffective in providing short-term symptom relief (varying levels of evidence) and steroid injections seem to be effective (limited evidence). There is conflicting evidence for the efficacy of ultrasound and oral steroids. For providing long-term relief from symptoms there is limited evidence that ultrasound is effective, and that splinting is less effective than surgery. In conclusion, there is still little known about the efficacy of most conservative treatment options for CTS. To establish stronger evidence more high quality trials are needed.

Nonsteroidal anti-inflammatory drugs for low back pain: An updated cochrane review

Study Design. A systematic review of randomized controlled trials. Objectives. To assess the effects of nonsteroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors in the treatment of nonspecific low back pain and to assess which type of NSAID is most effective. Summary of Background Data. NSAIDs are the most frequently prescribed medications worldwide and are widely used for patients with low back pain. Selective COX-2 inhibitors are currently available and used for patients with low back pain. Methods. We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials up to and including June 2007 if reported in English, Dutch, or German. We also screened references given in relevant reviews and identified trials. Randomized trials and double-blind controlled trials of NSAIDs in nonspecific low back pain with or without sciatica were included. Results. In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favor of NSAIDs compared with placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low back pain. COX-2 NSAIDs had statistically significantly fewer side effects than traditional NSAIDs. Conclusion. The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID, which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared with traditional NSAIDs in the randomized controlled trials included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations.

Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials

PURPOSE To assess the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) for low back pain. DATA SOURCES Computer aided search of published randomised clinical trials and assessment of the methods of the studies. STUDY SELECTION 26 randomised clinical trials evaluating NSAIDs for low back pain were identified. DATA EXTRACTION Score for quality (maximum = 100 points) of the methods based on four categories: study population; interventions; effect measurement; data presentation and analysis. Determination of success rate per study group and evaluation of different contrasts. Statistical pooling of placebo controlled trials in similar patient groups and using similar outcome measures. RESULTS The methods scores of the trials ranged from 27 to 83 points. NSAIDs were compared with placebo treatment in 10 studies. The pooled odds ratio in four trials comparing NSAIDs with placebo after one week was 0.53 (95% confidence intervals 0.32 to 0.89) using the fixed effect model, indicating a significant effect in favour of NSAIDs compared with placebo. In nine studies NSAIDs were compared with other (drug) therapies. Of these, only two studies reported better results of NSAIDs compared with paracetamol with and without dextropropoxyphene. In the other trials NSAIDs were not better than the reference treatment. In 11 studies different NSAIDs were compared, of which seven studies reported no differences in effect. CONCLUSIONS There are flaws in the design of most studies. The pooled odds ratio must be interpreted with caution because the trials at issue, including the high quality trials, did not use identical outcome measures. The results of the 26 randomised trials that have been carried out to date, suggest that NSAIDs might be effective for short-term symptomatic relief in patients with uncomplicated low back pain, but are less effective or ineffective in patients with low back pain with sciatica and patients with sciatica with nerve root symptoms.

The efficacy of non-steroidal anti-inflammatory drugs (NSAIDS) for shoulder complaints. A systematic review

The medical literature was evaluated with respect to the efficacy of NSAIDs for shoulder complaints. Nineteen randomized clinical trials met the selection criteria and were included in this review. Each publication was independently scored by two blinded reviewers, according to a standardized set of 17 methodological criteria. The studies were ranked according to their total methods score (maximum 100 points). The methodological quality of the majority of the studies was rather disappointing; only 5 trials received a methods score exceeding 50 points. Furthermore, methodological criteria were often inadequately described, particularly those regarding the randomization procedure, co-interventions and control of compliance. The three trials with the highest methods scores demonstrated superior short-term efficacy of NSAIDs in comparison with placebo intervention. Fourteen trials comparing two types of NSAIDs showed no conclusive evidence in favour of a particular NSAID with respect to efficacy or tolerability. Future studies should compare the benefit-risk ratios of NSAIDs and analgesics for shoulder complaints in order to establish whether the use of NSAIDs is more favourable than analgesics, despite the higher risk of adverse reactions from NSAIDs.

The effectiveness of bilateral cochlear implants for severe-to-profound deafness in children: a systematic review.

Objective: To assess the clinical effectiveness of bilateral cochlear implantation compared with unilateral cochlear implantation alone or with a contralateral hearing aid (bimodal stimulation), in children with severe-to-profound hearing loss. Recently, the National Institute for Health and Clinical Excellence (NICE) in the U.K. has conducted a systematic review on cochlear implantation. We decided to update the pediatric part of the NICE review. Data Sources: The electronic databases MEDLINE and Embase were searched for European, North American, and Australasian studies published between October 2006 and June 2009. Reference lists of the included articles were also searched for relevant articles. Study Selection: Studies were included if they comprised data on comparisons between bilateral cochlear implantation and unilateral cochlear implantation and/or bilateral cochlear implantation and bimodal stimulation, in children with severe-to-profound sensorineural hearing loss. The following outcome measures were analyzed: audiological, speech perception, speech production, functional capacities, health-related quality of life, and/or educational outcomes. Data Extraction: Characteristics of the participants, interventions, outcomes, and methodological comments were entered into data extraction forms and the level of evidence was assessed. Data Synthesis: Results were standardized for each outcome measure by calculating a standardized mean difference (effect size). Conclusion: Effect sizes could not be pooled because of the heterogeneity of the studies. Therefore, we presented the results qualitatively. Although the level of evidence was low, the advantages of bilateral cochlear implants corresponded with the primary benefits of bilateral hearing, that is, improved speech perception in quiet and noise. Localization results were less consistent. No data on audiologic, speech production, or educational outcomes were available.

Inter-observer reproducibility of measurements of range of motion in patients with shoulder pain using a digital inclinometer

BackgroundReproducible measurements of the range of motion are an important prerequisite for the interpretation of study results. The digital inclinometer is considered to be a useful instrument because it is inexpensive and easy to use. No previous study assessed inter-observer reproducibility of range of motion measurements with a digital inclinometer by physical therapists in a large sample of patients.MethodsTwo physical therapists independently measured the passive range of motion of the glenohumeral abduction and the external rotation in 155 patients with shoulder pain. Agreement was quantified by calculation of the mean differences between the observers and the standard deviation (SD) of this difference and the limits of agreement, defined as the mean difference ± 1.96*SD of this difference. Reliability was quantified by means of the intraclass correlation coefficient (ICC).ResultsThe limits of agreement were 0.8 ± 19.6 for glenohumeral abduction and -4.6 ± 18.8 for external rotation (affected side) and quite similar for the contralateral side and the differences between sides. The percentage agreement within 10° for these measurements were 72% and 70% respectively. The ICC ranged from 0.28 to 0.90 (0.83 and 0.90 for the affected side).ConclusionsThe inter-observer agreement was found to be poor. If individual patients are assessed by two different observers, differences in range of motion of less than 20–25 degrees can not be distuinguished from measurement error. In contrast, acceptable reliability was found for the inclinometric measurements of the affected side and the differences between the sides, indicating that the inclimeter can be used in studies in which groups are compared.

Investigation of publication bias in meta-analyses of diagnostic test accuracy: a meta-epidemiological study

BackgroundThe validity of a meta-analysis can be understood better in light of the possible impact of publication bias. The majority of the methods to investigate publication bias in terms of small study-effects are developed for meta-analyses of intervention studies, leaving authors of diagnostic test accuracy (DTA) systematic reviews with limited guidance. The aim of this study was to evaluate if and how publication bias was assessed in meta-analyses of DTA, and to compare the results of various statistical methods used to assess publication bias.MethodsA systematic search was initiated to identify DTA reviews with a meta-analysis published between September 2011 and January 2012. We extracted all information about publication bias from the reviews and the two-by-two tables. Existing statistical methods for the detection of publication bias were applied on data from the included studies.ResultsOut of 1,335 references, 114 reviews could be included. Publication bias was explicitly mentioned in 75 reviews (65.8%) and 47 of these had performed statistical methods to investigate publication bias in terms of small study-effects: 6 by drawing funnel plots, 16 by statistical testing and 25 by applying both methods. The applied tests were Egger’s test (n = 18), Deeks’ test (n = 12), Begg’s test (n = 5), both the Egger and Begg tests (n = 4), and other tests (n = 2). Our own comparison of the results of Begg’s, Egger’s and Deeks’ test for 92 meta-analyses indicated that up to 34% of the results did not correspond with one another.ConclusionsThe majority of DTA review authors mention or investigate publication bias. They mainly use suboptimal methods like the Begg and Egger tests that are not developed for DTA meta-analyses. Our comparison of the Begg, Egger and Deeks tests indicated that these tests do give different results and thus are not interchangeable. Deeks’ test is recommended for DTA meta-analyses and should be preferred.

The incidence of mild and severe hypoglycaemia in patients with type 2 diabetes mellitus treated with sulfonylureas: a systematic review and meta-analysis.

Patients with type 2 diabetes mellitus using sulfonylurea derivatives or insulin may experience hypoglycaemia. However, recent data regarding the incidence of hypoglycaemia are scarce. We conducted a systematic review and meta‐analysis to determine the proportion of patients with type 2 diabetes mellitus that experience hypoglycaemia when treated with sulfonylurea or insulin.

Pre-arrest predictors of survival after resuscitation from out-of-hospital cardiac arrest in the elderly a systematic review

BackgroundTo enable older people to make decisions about the appropriateness of cardiopulmonary resuscitation (CPR), information is needed about the predictive value of pre-arrest factors such as comorbidity, functional and cognitive status on survival and quality of life of survivors. We systematically reviewed the literature to identify pre-arrest predictors for survival, quality of life and functional outcomes after out-of-hospital (OHC) CPR in the elderly.MethodsWe searched MEDLINE (through May 2011) and included studies that described adults aged 70 years and over needing CPR after OHC cardiac arrest. Prognostic factors associated with survival to discharge and quality of life of survivors were extracted. Two authors independently appraised the quality of each of the included studies. When possible a meta-analysis of odd’s ratios was performed.ResultsTwenty-three studies were included (n = 44,582). There was substantial clinical and statistical heterogeneity and reporting was often inadequate. The pooled survival to discharge in patients >70 years was 4.1% (95% CI 3.0-5.6%). Several studies showed that increasing age was significantly associated with worse survival, but the predictive value of comorbidity was investigated in only one study. In another study, nursing home residency was independently associated with decreased chances of survival. Only a few small studies showed that age is negatively associated with a good quality of life of survivors. We were unable to perform a meta-analysis of possible predictors due to a wide variety in reporting and statistical methods.ConclusionsAlthough older patients have a lower chance of survival after CPR in univariate analysis (i.e. 4.1%), older age alone does not seem to be a good criterion for denying patients CPR. Evidence for the predictive value of comorbidities and for the predictive value of age on quality of life of survivors is scarce. Future studies should use uniform methods for reporting data and pre-arrest factors to increase the available evidence about pre arrest factors on the chance of survival. Furthermore, patient-specific outcomes such as quality of life and post-arrest cognitive function should be investigated too.