Description of massage interventions in randomised clinical trials for neck pain; a review using the TIDieR checklist.

OBJECTIVE: How interventions are reported can impact the ability to implement these intervention in clinical practice. Therefore, our aim is to assess the reporting of massage interventions in randomised controlled trials for patients with neck pain. DATA SOURCES: This manuscript concerns a secondary analysis of trials evaluating massage for neck pain selected for a scoping review. An updated literature search was completed using four databases to 31 July 2023. REVIEW METHODS: Trials were selected that evaluate massage interventions. Two independent assessors extracted descriptive information, methodological quality (PEDro-scale) and assessed completeness of reporting of the intervention using the Template for Intervention Description and Replication (TIDier-checklist). We present frequencies of the extracted data. RESULTS: We included 35 trials (2840 patients) with neck pain. Most trials (n = 23) included patients with chronic non-specific neck pain. We found a wide variety of massage interventions from Chinese massage, Swedish massage to myofascial release. In addition, the dose, number of sessions and the duration of the intervention varied widely. The methodological quality overall was fair to good (varied between 4-8/10), and we found a moderate completeness of reporting. All trials provided the name of the intervention, 30 (86%) provided a rationale and 26 (74%) trials described details of the massage intervention. CONCLUSION: The massage interventions were moderately described in trials in patients with neck pain, but provided enough information to guide the decision making for designing future Network Meta-analysis as to what trials need to be considered when grouping massage interventions in a clinically relevant way.

Clinical validation of grouping conservative treatments in neck pain for use in a network meta-analysis: a Delphi consensus study.

BACKGROUND: A network meta-analysis aims to help clinicians make clinical decisions on the most effective treatment for a certain condition. Neck pain is multifactorial, with various classification systems and treatment options. Classifying patients and grouping interventions in clinically relevant treatment nodes for a NMA is essential, but this process is poorly defined. OBJECTIVE: Our aim is to obtain consensus among experts on neck pain classifications and the grouping of interventions into nodes for a future network meta-analysis. DESIGN: A Delphi consensus study involving neck pain experts worldwide. METHODS: We invited authors of neck pain clinical practice guidelines published from 2014 onwards. The Delphi baseline questionnaire was developed based on the findings of a scoping review, including four items on classifications and 19 nodes. Participants were asked to record their level of agreement on a seven-point Likert scale or using Yes/No/Not sure answer options for the various statements. We used descriptive analysis to summarise the responses on each statement with content analysis of the free-text comments. RESULTS: In total, 18/80 experts (22.5%) agreed to participate in one or more Delphi rounds. We needed three rounds to reach consensus for two classification of neck pain: one based on aetiology and one on duration. In addition, we also reached consensus on the grouping of interventions, including a definition of each node, with the number of nodes reduced to 17. CONCLUSION: With this consensus we clinically validated two neck pain classifications and grouped conservative treatments into 17 well-defined and clinically relevant nodes.

Red flags to screen for vertebral fracture in people presenting with low back pain.

BACKGROUND: Low back pain is a common presentation across different healthcare settings. Clinicians need to confidently be able to screen and identify people presenting with low back pain with a high suspicion of serious or specific pathology (e.g. vertebral fracture). Patients identified with an increased likelihood of having a serious pathology will likely require additional investigations and specific treatment. Guidelines recommend a thorough history and clinical assessment to screen for serious pathology as a cause of low back pain. However, the diagnostic accuracy of recommended red flags (e.g. older age, trauma, corticosteroid use) remains unclear, particularly those used to screen for vertebral fracture. OBJECTIVES: To assess the diagnostic accuracy of red flags used to screen for vertebral fracture in people presenting with low back pain. Where possible, we reported results of red flags separately for different types of vertebral fracture (i.e. acute osteoporotic vertebral compression fracture, vertebral traumatic fracture, vertebral stress fracture, unspecified vertebral fracture). SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 26 July 2022. SELECTION CRITERIA: We considered primary diagnostic studies if they compared results of history taking or physical examination (or both) findings (index test) with a reference standard test (e.g. X-ray, magnetic resonance imaging (MRI), computed tomography (CT), single-photon emission computerised tomography (SPECT)) for the identification of vertebral fracture in people presenting with low back pain. We included index tests that were presented individually or as part of a combination of tests. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data for diagnostic two-by-two tables from the publications or reconstructed them using information from relevant parameters to calculate sensitivity, specificity, and positive (+LR) and negative (-LR) likelihood ratios with 95% confidence intervals (CIs). We extracted aspects of study design, characteristics of the population, index test, reference standard, and type of vertebral fracture. Meta-analysis was not possible due to heterogeneity of studies and index tests, therefore the analysis was descriptive. We calculated sensitivity, specificity, and LRs for each test and used these as an indication of clinical usefulness. Two review authors independently conducted risk of bias and applicability assessment using the QUADAS-2 tool. MAIN RESULTS: This review is an update of a previous Cochrane Review of red flags to screen for vertebral fracture in people with low back pain. We included 14 studies in this review, six based in primary care, five in secondary care, and three in tertiary care. Four studies reported on 'osteoporotic vertebral fractures', two studies reported on 'vertebral compression fracture', one study reported on 'osteoporotic and traumatic vertebral fracture', two studies reported on 'vertebral stress fracture', and five studies reported on 'unspecified vertebral fracture'. Risk of bias was only rated as low in one study for the domains reference standard and flow and timing. The domain patient selection had three studies and the domain index test had six studies rated at low risk of bias. Meta-analysis was not possible due to heterogeneity of the data. Results from single studies suggest only a small number of the red flags investigated may be informative. In the primary healthcare setting, results from single studies suggest 'trauma' demonstrated informative +LRs (range: 1.93 to 12.85) for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture' (+LR: 6.42, 95% CI 2.94 to 14.02). Results from single studies suggest 'older age' demonstrated informative +LRs for studies in primary care for 'unspecified vertebral fracture' (older age greater than 70 years: 11.19, 95% CI 5.33 to 23.51). Results from single studies suggest 'corticosteroid use' may be an informative red flag in primary care for 'unspecified vertebral fracture' (+LR range: 3.97, 95% CI 0.20 to 79.15 to 48.50, 95% CI 11.48 to 204.98) and 'osteoporotic vertebral fracture' (+LR: 2.46, 95% CI 1.13 to 5.34); however, diagnostic values varied and CIs were imprecise. Results from a single study suggest red flags as part of a combination of index tests such as 'older age and female gender' in primary care demonstrated informative +LRs for 'unspecified vertebral fracture' (16.17, 95% CI 4.47 to 58.43). In the secondary healthcare setting, results from a single study suggest 'trauma' demonstrated informative +LRs for 'unspecified vertebral fracture' (+LR: 2.18, 95% CI 1.86 to 2.54) and 'older age' demonstrated informative +LRs for 'osteoporotic vertebral fracture' (older age greater than 75 years: 2.51, 95% CI 1.48 to 4.27). Results from a single study suggest red flags as part of a combination of index tests such as 'older age and trauma' in secondary care demonstrated informative +LRs for 'unspecified vertebral fracture' (+LR: 4.35, 95% CI 2.92 to 6.48). Results from a single study suggest when '4 of 5 tests' were positive in secondary care, they demonstrated informative +LRs for 'osteoporotic vertebral fracture' (+LR: 9.62, 95% CI 5.88 to 15.73). In the tertiary care setting, results from a single study suggest 'presence of contusion/abrasion' was informative for 'vertebral compression fracture' (+LR: 31.09, 95% CI 18.25 to 52.96). AUTHORS' CONCLUSIONS: The available evidence suggests that only a few red flags are potentially useful in guiding clinical decisions to further investigate people suspected to have a vertebral fracture. Most red flags were not useful as screening tools to identify vertebral fracture in people with low back pain. In primary care, 'older age' was informative for 'unspecified vertebral fracture', and 'trauma' and 'corticosteroid use' were both informative for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture'. In secondary care, 'older age' was informative for 'osteoporotic vertebral fracture' and 'trauma' was informative for 'unspecified vertebral fracture'. In tertiary care, 'presence of contusion/abrasion' was informative for 'vertebral compression fracture'. Combinations of red flags were also informative and may be more useful than individual tests alone. Unfortunately, the challenge to provide clear guidance on which red flags should be used routinely in clinical practice remains. Further research with primary studies is needed to improve and consolidate our current recommendations for screening for vertebral fractures to guide clinical care.

The barriers and facilitators to satisfaction with botulinum neurotoxin treatment in people with cervical dystonia: a systematic review.

BACKGROUND: Cervical dystonia (CD) is an isolated, focal, idiopathic dystonia affecting the neck and upper back. CD is usually treated by botulinum neurotoxin (BoNT) injections into the dystonic muscles; however, about 20% of people will discontinue BoNT therapy. This systematic review aimed to determine the barriers to satisfaction and facilitators that could improve satisfaction with BoNT therapy for people with CD. METHODS: A database search for journal articles investigating satisfaction with BoNT treatment in CD identified seven qualitative studies and one randomised controlled trial. Results were grouped into "direct" and "indirect" barriers and facilitators. RESULTS: The most reported direct barrier to satisfaction with BoNT was treatment non-response, reported by up to 66% of participants. Other direct barriers included negative side effects, early wearing-off of treatment effect and inexperience of the treating physician. Indirect barriers included limited accessibility to treatment (including cost) and personal choice. Direct facilitators of satisfaction with BoNT included relief of symptoms and flexible re-treatment intervals. Indirect facilitators included easy accessibility to treatment. CONCLUSIONS: Despite BoNT having a discontinuation rate of only 20%, it appears a much greater proportion of people with CD are dissatisfied with this treatment. As BoNT is currently the main treatment offered to people with CD, efforts to improve treatment response rates, reduce side effects and make treatment more flexible and readily available should be adopted to improve the quality of life for people with CD.

Effectiveness of brief patient information materials for promoting correct beliefs about imaging and inevitable consequences of low back pain: A randomised controlled trial.

OBJECTIVE: To investigate what format for providing patient information (i.e. written summary, infographic or video animation) is most effective for promoting correct beliefs about imaging and inevitable consequences of low back pain (LBP). DESIGN: Randomised controlled trial. SETTING/PATIENTS: One hundred and fifty-nine patients with non-specific LBP were recruited from outpatient physiotherapy clinics. INTERVENTION: Participants were randomised to receive patient information in one of three formats: video animation, infographic or written summary. Patients were allowed to read or watch the materials for up to 20 min. MEASUREMENTS: Outcome were assessed before and immediately after the intervention. The primary outcome was the Back Beliefs Questionnaire. The secondary outcome was beliefs about imaging for LBP assessed by two questions. RESULTS: All 159 patients completed the study. Our findings revealed no difference between groups for the Back Beliefs Questionnaire. Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4; Question 2- OR = 3.7, 95%CI: 1.6, 8.5). No difference between infographic and written summary formats were reported for the questions assessing LBP imaging beliefs. CONCLUSION: The three materials were equally effective in improving patient's general beliefs about LBP care. However, the traditional written summary or infographic formats were more effective than the video animation format for improving beliefs about imaging for LBP.

Cost-Effectiveness of Radiofrequency Denervation for Patients With Chronic Low Back Pain: The MINT Randomized Clinical Trials.

OBJECTIVES: To evaluate the cost-effectiveness of radiofrequency denervation when added to a standardized exercise program for patients with chronic low back pain. METHODS: An economic evaluation was conducted alongside 3 pragmatic multicenter, nonblinded randomized clinical trials (RCTs) in The Netherlands with a follow up of 52 weeks. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain; a positive diagnostic block at the facet joints (n = 251), sacroiliac (SI) joints (n = 228), or a combination of facet joints, SI joints, and intervertebral discs (n = 202); and were unresponsive to initial conservative care. Quality-adjusted life-years (QALYs) and societal costs were measured using self-reported questionnaires. Missing data were imputed using multiple imputation. Bootstrapping was used to estimate statistical uncertainty. RESULTS: After 52 weeks, no difference in costs between groups was found in the facet joint or combination RCT. The total costs were significantly higher for the intervention group in the SI joint RCT. The maximum probability of radiofrequency denervation being cost-effective when added to a standardized exercise program ranged from 0.10 in the facet joint RCT to 0.17 in the SI joint RCT irrespective of the ceiling ratio, and 0.65 at a ceiling ratio of €30 000 per QALY in the combination RCT. CONCLUSIONS: Although equivocal among patients with symptoms in a combination of the facet joints, SI joints, and intervertebral discs, evidence suggests that radiofrequency denervation combined with a standardized exercise program cannot be considered cost-effective from a societal perspective for patients with chronic low back pain originating from either facet or SI joints in a Dutch healthcare setting.

Differences in Patient Characteristics, Number of Treatments, and Recovery Rates Between Referred and Self-referred Patients With Nonspecific Neck Pain in Manual Therapy: A Secondary Analysis.

OBJECTIVE: In various countries, patients can visit a physiotherapist via self-referral. The aims of this study were to evaluate whether there are differences between individuals with nonspecific neck pain who consult a manual therapist via self-referral and those who do so via referral by a physician concerning patient characteristics, number of treatments, and recovery; and whether (self-)referral is associated with recovery. METHODS: This study is part of a prospective cohort study with posttreatment and 12-month follow-up in a Dutch manual-therapy setting. Adult patients with nonspecific neck pain were eligible for participation. Baseline measurements included demographic data and data concerning neck pain. At follow-up, number of treatments, recovery, and satisfaction were assessed. To evaluate differences between the groups, we used the χ2 test and the independent t test. A logistic regression analysis was used to evaluate the association between referral status and recovery. RESULTS: In total, 272 manual therapists participated and 1311 patients were included. Of 831 patients whose referral data are available, about half patients consulted a manual therapist by self-referral. The mean number of treatments was 5.4, which did not differ between the 2 groups. We found no differences between the groups concerning age, sex, pain intensity at baseline, or recovery rate. Patients in the self-referral group experienced acute neck pain more frequently, had recurrent complaints more often, and reported less disability compared to the referred group. Referral status was not associated with recovery. CONCLUSION: We found several small differences between self-referred and referred patients.

The Effect of a Personalized Newsletter to Physical Therapists on Patient Recruitment: A Cluster Randomized Trial in Primary Physiotherapy Care.

OBJECTIVE: To assess the effect of a personalized newsletter compared with a standard newsletter on patient recruitment in physiotherapy research. METHODS: We performed a cluster-randomized trial including 120 physiotherapists who recruited patients for a prospective cohort and were randomly assigned to either receiving personalized feedback in a newsletter (intervention group) or a standard newsletter (control group). We calculated the difference in the number of patients included in the study corrected for inclusion time between both groups. RESULTS: The physiotherapists in the control group (n = 59) included 110 patients (35.4% of the total number of patients included) compared with an inclusion of 200 patients (64.6% of the total number of patients included) by the physiotherapists in the intervention group (n = 61), a difference of 90 patients in favor of the intervention group. However, when corrected for inclusion time and a cluster effect, we found no statistically significant difference between both groups. In addition, therapists who did not include a single patient (inactive therapists) were evenly divided between the 2 groups (n = 29 [49%] in the control group; n = 30 [49%] in the intervention group). CONCLUSIONS: A personalized newsletter does not significantly increase the number of recruited patients by physiotherapists. However, therapists receiving personalized feedback recruited nearly double the number of patients compared with the ones receiving standard feedback.

Patients' experience of shoulder disorders: a systematic review of qualitative studies for the OMERACT Shoulder Core Domain Set.

OBJECTIVES: To describe the experiences (including symptoms and perceived impacts on daily living) of people with a shoulder disorder. METHODS: Systematic review of qualitative studies. We searched for eligible qualitative studies indexed in Ovid MEDLINE, Ovid Embase, CINAHL (EBSCO), SportDiscus (EBSCO) and Ovid PsycINFO up until November 2017. Two authors independently screened studies for inclusion, appraised their methodological quality using the Critical Appraisal Skills Programme checklist, used thematic synthesis methods to generate themes describing the experiences reported by participants and assessed the confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) approach. RESULTS: The inclusion criteria were met by eight studies, which included 133 participants (49 females and 84 males) with either rotator cuff disease, adhesive capsulitis, proximal humeral fracture, shoulder instability or unspecified shoulder pain. We generated seven themes to describe what people in the included studies reported experiencing: pain; physical function/activity limitations; participation restriction; sleep disruption; cognitive dysfunction; emotional distress; and other pathophysiological manifestations (other than pain). There were interactions between the themes, with particular experiences impacting on others (e.g. pain leading to reduced activities and sleep disruption). Following grading of the evidence, we considered it likely that most of the review findings were a reasonable representation of the experiences of people with shoulder disorders. CONCLUSION: Patients with shoulder disorders contend with considerable disruption to their life. The experiences described should be considered by researchers seeking to select the most appropriate outcomes to measure in clinical trials and other research studies in people with shoulder disorders.

Prospective Cohort Study of Patients With Neck Pain in a Manual Therapy Setting: Design and Baseline Measures.

OBJECTIVES: The purpose of this study was to describe the design and baseline measurements of a prospective multicenter cohort study in patients with neck pain treated by Dutch manual therapists. Objectives of the study were to determine which patients seek help from a manual therapist, to describe usual care manual therapy in patients with neck pain, to examine the occurrence of nonserious adverse events after treatment, to describe predictors of adverse events, and to determine whether the occurrence of nonserious adverse events affect outcome after manual therapy care. METHODS: During a 3-month inclusion period, consecutive patients aged between 18 and 80 years presenting with neck pain in manual therapy practices in The Netherlands were included in the study. Baseline questionnaires included the Numeric Rating Scale, Neck Disability Index (NDI), Neck Bournemouth Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ), and Patient Expectancy List. Within the treatment episode, manual therapist clinical reasoning and applied interventions were registered and patients reported on adverse events. At the end of the treatment episode and at 12-month follow-up, pain intensity (Numeric Rating Scale), functional outcomes (NDI, Neck Bournemouth Questionnaire), personal factors (FABQ), and global perceived effect were measured. RESULTS: During the 3-month inclusion period, 263 participating manual therapists collected data on 1193 patients with neck pain. Most patients (69.4%) were female. The mean age was 44.7 (±13.7) years. The NDI showed overall mild disability (mean score 26%). Mean scores in pain intensity were moderate (4.8), and there was low risk of prolonged disability owing to personal factors (FABQ). CONCLUSION: This study provides information on baseline characteristics of patients visiting manual therapists for neck pain. In The Netherlands, patients seeking care of manual therapists are comparable to patients in other countries regarding demographics and neck pain characteristics.

Can Primary Care for Back and/or Neck Pain in the Netherlands Benefit From Stratification for Risk Groups According to the STarT Back Tool Classification?

OBJECTIVE: To evaluate whether current Dutch primary care clinicians offer tailored treatment to patients with low back pain (LBP) or neck pain (NP) according to their risk stratification, based on the Keele STarT (Subgroup Targeted Treatment) Back-Screening Tool (SBT). DESIGN: Prospective cohort study with 3-month follow-up. SETTING: Primary care. PARTICIPANTS: General practitioners (GPs) and physiotherapists included patients (N=284) with nonspecific LBP, NP, or both. INTERVENTIONS: Patients completed a baseline questionnaire, including the Dutch SBT, for either LBP or NP. A follow-up measurement was conducted after 3 months to determine recovery (using Global Perceived Effect Scale), pain (using Numeric Pain Rating Scale), and function (using Roland Disability Questionnaire or Neck Disability Index). A questionnaire was sent to the GPs and physiotherapists to evaluate the provided treatment. MAIN OUTCOME MEASURES: Prevalence of patients' risk profile and clinicians' applied care, and the percentage of patients with persisting disability at follow-up. A distinction was made between patients receiving the recommended treatment and those receiving the nonrecommended treatment. RESULTS: In total, 12 GPs and 33 physiotherapists included patients. After 3 months, we analyzed 184 patients with LBP and 100 patients with NP. In the LBP group, 52.2% of the patients were at low risk for persisting disability, 38.0% were at medium risk, and 9.8% were at high risk. Overall, 24.5% of the patients with LBP received a low-risk treatment approach, 73.5% a medium-risk, and 2.0% a high-risk treatment approach. The specific agreement between the risk profile and the received treatment for patients with LBP was poor for the low-risk and high-risk patients (21.1% and 10.0%, respectively), and fair for medium-risk patients (51.4%). In the NP group, 58.0% of the patients were at low risk for persisting disability, 37.0% were at medium risk, and 5.0% were at high risk. Only 6.1% of the patients with NP received the low-risk treatment approach. The medium-risk treatment approach was offered the most (90.8%), and the high-risk approach was applied in only 3.1% of the patients. The specific agreement between the risk profile and received treatment for patients with NP was poor for low-risk and medium-risk patients (6.3% and 48.0%, respectively); agreement for high-risk patients could not be calculated. CONCLUSIONS: Current Dutch primary care for patients with nonspecific LBP, NP, or both does not correspond to the recommended stratified-care approach based on the SBT, as most patients receive medium-risk treatment. Most low-risk patients are overtreated, and most high-risk patients are undertreated. Although the stratified-care approach has not yet been validated in Dutch primary care, these results indicate there may be substantial room for improvement.

Clinical course and prognostic models for the conservative management of cervical radiculopathy: a prospective cohort study.

PURPOSE: To describe the clinical course and develop prognostic models for poor recovery in patients with cervical radiculopathy who are managed conservatively. METHODS: Sixty-one consecutive adults with cervical radiculopathy who were referred for conservative management were included in a prospective cohort study, with 6- and 12-month follow-up assessments. Exclusion criteria were the presence of known serious pathology or spinal surgery in the past. Outcome measures were perceived recovery, neck pain intensity and disability level. Multiple imputation analyses were performed for missing values. Prognostic models were developed using multivariable logistic regression analyses, with bootstrapping techniques for internal validation. RESULTS: About 55% of participants reported to be recovered at 6 and 12 months. All multivariable models contained 2 baseline predictors. Longer symptoms duration increased the risk of poor perceived recovery, whereas the presence of paresthesia decreased this risk. A higher neck pain intensity and a longer duration of symptoms increased the risk of poor relief of neck pain. A higher disability score increased the risk of poor relief of disability, and larger active range of rotation toward the affected side decreased this risk. Following bootstrapping, the explained variance of the models varied between 0.22 and 0.30, and the median area under the curve varied between 0.75 and 0.79. CONCLUSIONS: The clinical course of cervical radiculopathy appears to be long, with most of the reduction in symptoms occurring within the first 6 months. All prognostic models showed an adequate predictive performance with modest diagnostic accuracy and explained variance. These slides can be retrieved under Electronic Supplementary Material.

Patient Nonadherence to Guideline-Recommended Care in Acute Low Back Pain.

OBJECTIVE: To describe the magnitude of patient-reported nonadherence with guideline-recommended care for acute low back pain. DESIGN: Secondary analysis of data from participants enrolled in the Paracetamol for Acute Low Back Pain study trial, a randomized controlled trial evaluating the effectiveness of paracetamol for acute low back pain. SETTING: Primary care, general practitioner. PARTICIPANTS: Data from participants with acute low back pain (N=1643). INTERVENTIONS: Guideline-recommended care, including reassurance, simple analgesia, and the advice to stay active and avoid bed rest. Also, advice against additional treatments and referral for imaging. MAIN OUTCOME MEASURES: Proportion of nonadherence with guideline-recommended care. Nonadherence was defined as (1) failure to consume the advised paracetamol dose, or (2) receipt of additional health care, tests, or medication during the trial treatment period (4wk). Multivariable logistic regression analysis was performed to determine the factors associated with nonadherence. RESULTS: In the first week of treatment, 39.7% of participants were classified as nonadherent. Over the 4-week treatment period, 70.0% were nonadherent, and 57.5% did not complete the advised paracetamol regimen. Higher perceived risk of persistent pain, lower level of disability, and not claiming workers' compensation were associated with nonadherence, with odds ratios ranging from .46 to 1.05. CONCLUSIONS: Adherence to guideline-recommended care for acute low back pain was poor. Most participants do not complete the advised paracetamol regimen. Higher perceived risk of persistence of complaints, lower baseline disability, and participants not claiming workers' compensation were independently associated with nonadherence.

Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials.

IMPORTANCE: Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking. OBJECTIVE: To evaluate the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain. DESIGN, SETTING, AND PARTICIPANTS: Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in the Netherlands. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care. INTERVENTIONS: All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3. MAIN OUTCOMES AND MEASURES: The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015. RESULTS: Among 681 participants who were randomized (mean age, 52.2 years; 421 women [61.8%], mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was -0.18 (95% CI, -0.76 to 0.40) in the facet joint trial; -0.71 (95% CI, -1.35 to -0.06) in the sacroiliac joint trial; and -0.99 (95% CI, -1.73 to -0.25) in the combination trial. CONCLUSIONS AND RELEVANCE: In 3 randomized clinical trials of participants with chronic low back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a standardized exercise program resulted in either no improvement or no clinically important improvement in chronic low back pain compared with a standardized exercise program alone. The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources. TRIAL REGISTRATION: trialregister.nl Identifier: NTR3531.

Red flags presented in current low back pain guidelines: a review.

OBJECTIVE: The purpose of this study was to identify and descriptively compare the red flags endorsed in guidelines for the detection of serious pathology in patients presenting with low back pain to primary care. METHOD: We searched databases, the World Wide Web and contacted experts aiming to find the multidisciplinary clinical guideline in low back pain in primary care, and selected the most recent one per country. We extracted data on the number and type of red flags for identifying patients with higher likelihood of serious pathology. Furthermore, we extracted data on whether or not accuracy data (sensitivity/specificity, predictive values, etc.) were presented to support the endorsement of specific red flags. RESULTS: We found 21 discrete guidelines all published between 2000 and 2015. One guideline could not be retrieved and after selecting one guideline per country we included 16 guidelines in our analysis from 15 different countries and one for Europe as a whole. All guidelines focused on the management of patients with low back pain in a primary care or multidisciplinary care setting. Five guidelines presented red flags in general, i.e., not related to any specific disease. Overall, we found 46 discrete red flags related to the four main categories of serious pathology: malignancy, fracture, cauda equina syndrome and infection. The majority of guidelines presented two red flags for fracture ('major or significant trauma' and 'use of steroids or immunosuppressors') and two for malignancy ('history of cancer' and 'unintentional weight loss'). Most often pain at night or at rest was also considered as a red flag for various underlying pathologies. Eight guidelines based their choice of red flags on consensus or previous guidelines; five did not provide any reference to support the choice of red flags, three guidelines presented a reference in general, and data on diagnostic accuracy was rarely provided. CONCLUSION: A wide variety of red flags was presented in guidelines for low back pain, with a lack of consensus between guidelines for which red flags to endorse. Evidence for the accuracy of recommended red flags was lacking.

A diagnostic study in patients with sciatica establishing the importance of localization of worsening of pain during coughing, sneezing and straining to assess nerve root compression on MRI.

PURPOSE: To test whether the localization of worsening of pain during coughing, sneezing and straining matters in the assessment of lumbosacral nerve root compression or disc herniation on MRI. METHODS: Recently the diagnostic accuracy of history items to assess disc herniation or nerve root compression on magnetic resonance imaging (MRI) was investigated. A total of 395 adult patients with severe sciatica of 6-12 weeks duration were included in this study. The question regarding the influence of coughing, sneezing and straining on the intensity of pain could be answered on a 4 point scale: no worsening of pain, worsening of back pain, worsening of leg pain, worsening of back and leg pain. Diagnostic odds ratio's (DORs) were calculated for the various dichotomization options. RESULTS: The DOR changed into significant values when the answer option was more narrowed to worsening of leg pain. The highest DOR was observed for the answer option 'worsening of leg pain' with a DOR of 2.28 (95 % CI 1.28-4.04) for the presence of nerve root compression and a DOR of 2.50 (95 % CI 1.27-4.90) for the presence of a herniated disc on MRI. CONCLUSIONS: Worsening of leg pain during coughing, sneezing or straining has a significant diagnostic value for the presence of nerve root compression and disc herniation on MRI in patients with sciatica. This study also highlights the importance of the formulation of answer options in history taking.

The Dutch Shoulder Pain and Disability Index (SPADI): a reliability and validation study.

PURPOSE: To evaluate the reliability and validity of the Dutch Shoulder Pain and Disability Index (SPADI-D). BACKGROUND: The SPADI is recommended and frequently used. However, the validity and reliability of the SPADI-D are unknown. METHODS: The study population consisted of patients consulting a physical therapist for shoulder pain. We assessed construct validity, using known groups, convergent validity (SDQ) and divergent validity (EQ5D) for which the mean difference or Spearman correlations coefficients were calculated. The factor structure was assessed using principal component factor analysis, and we calculated Cronbach's alpha and the ICC to assess the reliability. RESULTS: A total of 356 patients and a randomly selected group of 74 subjects for the reliability analysis were included. There was a significant difference between extreme groups (a high/low level of pain and work absence/presence) in SPADI score. The correlation between the SPADI and the SDQ was 0.69, with the EQ5D mobility-item 0.25 and with the depression-item 0.14. The SPADI consisted of one factor according to principal component factor analysis, which showed high internal consistency (Cronbach's alpha = 0.94 for the total score), and the test-retest reliability was good (ICC = 0.89). CONCLUSION: The Dutch SPADI is a valid and reliable questionnaire for patients in primary care in assessing functional disability.

Balneotherapy (or spa therapy) for rheumatoid arthritis.

BACKGROUND: No cure for rheumatoid arthritis (RA) is known at present, so treatment often focuses on management of symptoms such as pain, stiffness and mobility. Treatment options include pharmacological interventions, physical therapy treatments and balneotherapy. Balneotherapy is defined as bathing in natural mineral or thermal waters (e.g. mineral baths, sulphur baths, Dead Sea baths), using mudpacks or doing both. Despite its popularity, reported scientific evidence for the effectiveness or efficacy of balneotherapy is sparse. This review, which evaluates the effects of balneotherapy in patients with RA, is an update of a Cochrane review first published in 2003 and updated in 2008. OBJECTIVES: To perform a systematic review on the benefits and harms of balneotherapy in patients with RA in terms of pain, improvement, disability, tender joints, swollen joints and adverse events. SEARCH METHODS: We searched the Cochrane 'Rehabilitation and Related Therapies' Field Register (to December 2014), the Cochrane Central Register of Controlled Trials (2014, Issue 1), MEDLIINE (1950 to December 2014), EMBASE (1988 to December 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to December 2014), the Allied and Complementary Medicine Database (AMED) (1985 to December 2014), PsycINFO (1806 to December 2014) and the Physiotherapy Evidence Database (PEDro). We applied no language restrictions; however, studies not reported in English, Dutch, Danish, Swedish, Norwegian, German or French are awaiting assessment. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing and recently completed trials. SELECTION CRITERIA: Studies were eligible if they were randomised controlled trials (RCTs) consisting of participants with definitive or classical RA as defined by the American Rheumatism Association (ARA) criteria of 1958, the ARA/American College of Rheumatology (ACR) criteria of 1988 or the ACR/European League Against Rheumatism (EULAR) criteria of 2010, or by studies using the criteria of Steinbrocker.Balneotherapy had to be the intervention under study, and had to be compared with another intervention or with no intervention.The World Health Organization (WHO) and the International League Against Rheumatism (ILAR) determined in 1992 a core set of eight endpoints in clinical trials concerning patients with RA. We considered pain, improvement, disability, tender joints, swollen joints and adverse events among the main outcome measures. We excluded studies when only laboratory variables were reported as outcome measures. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, performed data extraction and assessed risk of bias. We resolved disagreements by consensus and, if necessary, by third party adjudication. MAIN RESULTS: This review includes two new studies and a total of nine studies involving 579 participants. Unfortunately, most studies showed an unclear risk of bias in most domains. Four out of nine studies did not contribute to the analysis, as they presented no data.One study involving 45 participants with hand RA compared mudpacks versus placebo. We found no statistically significant differences in terms of pain on a 0 to 100-mm visual analogue scale (VAS) (mean difference (MD) 0.50, 95% confidence interval (CI) -0.84 to 1.84), improvement (risk ratio (RR) 0.96, 95% CI 0.54 to 1.70) or number of swollen joints on a scale from 0 to 28 (MD 0.60, 95% CI -0.90 to 2.10) (very low level of evidence). We found a very low level of evidence of reduction in the number of tender joints on a scale from 0 to 28 (MD -4.60, 95% CI -8.72 to -0.48; 16% absolute difference). We reported no physical disability and presented no data on withdrawals due to adverse events or on serious adverse events.Two studies involving 194 participants with RA evaluated the effectiveness of additional radon in carbon dioxide baths. We found no statistically significant differences between groups for all outcomes at three-month follow-up (low to moderate level of evidence). We noted some benefit of additional radon at six months in terms of pain frequency (RR 0.6, 95% CI 0.4 to 0.9; 31% reduction; improvement in one or more points (categories) on a 4-point scale; moderate level of evidence) and 9.6% reduction in pain intensity on a 0 to 100-mm VAS (MD 9.6 mm, 95% CI 1.6 to 17.6; moderate level of evidence). We also observed some benefit in one study including 60 participants in terms of improvement in one or more categories based on a 4-point scale (RR 2.3, 95% CI 1.1 to 4.7; 30% absolute difference; low level of evidence). Study authors did not report physical disability, tender joints, swollen joints, withdrawals due to adverse events or serious adverse events.One study involving 148 participants with RA compared balneotherapy (seated immersion) versus hydrotherapy (exercises in water), land exercises or relaxation therapy. We found no statistically significant differences in pain on the McGill Questionnaire or in physical disability (very low level of evidence) between balneotherapy and the other interventions. No data on improvement, tender joints, swollen joints, withdrawals due to adverse events or serious adverse events were presented.One study involving 57 participants with RA evaluated the effectiveness of mineral baths (balneotherapy) versus Cyclosporin A. We found no statistically significant differences in pain intensity on a 0 to 100-mm VAS (MD 9.64, 95% CI -1.66 to 20.94; low level of evidence) at 8 weeks (absolute difference 10%). We found some benefit of balneotherapy in overall improvement on a 5-point scale at eight weeks of 54% (RR 2.35, 95% CI 1.44 to 3.83). We found no statistically significant differences (low level of evidence) in the number of swollen joints, but some benefit of Cyclosporin A in the number of tender joints (MD 8.9, 95% CI 3.8 to 14; very low level of evidence). Physical disability, withdrawals due to adverse events and serious adverse events were not reported. AUTHORS' CONCLUSIONS: Overall evidence is insufficient to show that balneotherapy is more effective than no treatment, that one type of bath is more effective than another or that one type of bath is more effective than mudpacks, exercise or relaxation therapy.