The long-term effects of naprapathic manual therapy on back and neck pain - Results from a pragmatic randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Back and neck pain are very common, disabling and recurrent disorders in the general population and the knowledge of long-term effect of treatments are sparse. The aim of this study was to compare the long-term effects (up to one year) of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain. Naprapathy, a health profession mainly practiced in Sweden, Finland, Norway and in the USA, is characterized by a combination of manual musculoskeletal manipulations, aiming to decrease pain and disability in the neuromusculoskeletal system.</p> <p>Methods</p> <p>Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (<it>Index Group</it>), and advice to stay active and on how to cope with pain, provided by a physician (C<it>ontrol Group</it>). Pain intensity, disability and health status were measured by questionnaires.</p> <p>Results</p> <p>89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, <it>95% CI: 10-30</it>) and disability (RD = 11%, <it>95% CI: 4-22</it>) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, <it>95% CI: 7-27 </it>and disability: RD = 17%, <it>95% CI: 5-28</it>). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p ≤ 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.</p> <p>Conclusions</p> <p>Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN56954776.</p

Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: Protocol for a three-armed randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise.</p> <p>Methods/Design</p> <p>This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months.</p> <p>Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion.</p> <p>Discussion</p> <p>To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis.</p> <p>Trial registration</p> <p>ClinicalTrials <a href="http://www.clinicaltrials.gov/ct2/show/NCT01039337">NCT01039337</a></p

The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies.

BACKGROUND: Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. METHODS: Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). RESULTS: 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). CONCLUSIONS: The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared 'natural history', enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design

Review of methods used by chiropractors to determine the site for applying manipulation

Background: With the development of increasing evidence for the use of manipulation in the management of musculoskeletal conditions, there is growing interest in identifying the appropriate indications for care. Recently, attempts have been made to develop clinical prediction rules, however the validity of these clinical prediction rules remains unclear and their impact on care delivery has yet to be established. The current study was designed to evaluate the literature on the validity and reliability of the more common methods used by doctors of chiropractic to inform the choice of the site at which to apply spinal manipulation. Methods: Structured searches were conducted in Medline, PubMed, CINAHL and ICL, supported by hand searches of archives, to identify studies of the diagnostic reliability and validity of common methods used to identify the site of treatment application. To be included, studies were to present original data from studies of human subjects and be designed to address the region or location of care delivery. Only English language manuscripts from peer-reviewed journals were included. The quality of evidence was ranked using QUADAS for validity and QAREL for reliability, as appropriate. Data were extracted and synthesized, and were evaluated in terms of strength of evidence and the degree to which the evidence was favourable for clinical use of the method under investigation. Results: A total of 2594 titles were screened from which 201 articles met all inclusion criteria. The spectrum of manuscript quality was quite broad, as was the degree to which the evidence favoured clinical application of the diagnostic methods reviewed. The most convincing favourable evidence was for methods which confirmed or provoked pain at a specific spinal segmental level or region. There was also high quality evidence supporting the use, with limitations, of static and motion palpation, and measures of leg length inequality. Evidence of mixed quality supported the use, with limitations, of postural evaluation. The evidence was unclear on the applicability of measures of stiffness and the use of spinal x-rays. The evidence was of mixed quality, but unfavourable for the use of manual muscle testing, skin conductance, surface electromyography and skin temperature measurement. Conclusions: A considerable range of methods is in use for determining where in the spine to administer spinal manipulation. The currently published evidence falls across a spectrum ranging from strongly favourable to strongly unfavourable in regard to using these methods. In general, the stronger and more favourable evidence is for those procedures which take a direct measure of the presumptive site of care– methods involving pain provocation upon palpation or localized tissue examination. Procedures which involve some indirect assessment for identifying the manipulable lesion of the spine–such as skin conductance or thermography–tend not to be supported by the available evidence.https://doi.org/10.1186/2045-709X-21-3

Final report on practical assessment of the RESCUE architecture:ICT-619555 RESCUE D4.4 Version 1.0

Abstract This deliverable summarizes the practical assessment of the links-on-the-fly concept. To do so, a software and hardware integration based on GNU Radio and SDR devices has been performed. Intensive verification and validation within three different testing facilities provided a stable framework for the subsequent assessment. The evaluation strategy comprises experiments under controllable and reproducible test conditions considering the OTAinVEE approach followed by field trials in an indoor testbed emulating the public safety use case, as well as outdoor tests emulating the V2V scenario. Finally, the outcomes of the practical evaluations are compared and analyzed jointly. These results are also analyzed in the light of previous outcomes from other work packages within the RESCUE project.Executive summary D4.4 is the final report of WP4. It presents the software and hardware integration into the selected SDR platform as well as the functional validation and first results within the OTAinVEE test facility. Moreover, two real field experimental trials have been planned and conducted for an indoor and outdoor scenario respectively. The deliverable aims to close the performance validation circle envisaged within the RESCUE project: increasing degree of realistic assumptions during the specific validation stages starting from WP1 over to WP2 and WP3 and finally to WP4. However, real field experiments are usually limited by the number of device deployments, capabilities of the selected software and hardware platform as well as limits in the available experimental time-frame. Therefore, the reported experiments cover the basic scenarios TS0 and TS1, consisting of two and three nodes, respectively. The deliverable consists of four main parts. The first part gives a detailed technical background of the software and hardware framework used to incorporate the RESCUE architecture. For this reason, and in order to obtain stable, reproducible and trustable results, the open-source GNU Radio framework and USRPs from Ettus/National Instruments have been selected as a compromise between flexibility, performance, and costs. Standard building blocks from GNU Radio have been customized to provide a basic physical and MAC layout. Contributions from WP2 and WP3 in terms of implemented software blocks were integrated, including the RESCUE coding algorithms (from WP2) and the network protocols (from WP3). Besides iterative bug fixing and code optimization, the challenging tasks during the testbed verification were the frame synchronization, SNR estimation, and calibration of the testbeds between different WP4 partners. The second part summarizes the verification and experiments based on the OTAinVEE (over-the-air in a virtual electromagnetic environment) concept. Within RESCUE, this specific validation stage turned out to be very valuable since the controllable and reproducible test conditions allowed for deep software and hardware verification followed by intensive performance validation before the real field experiments were conducted. The third part of the deliverable focuses on the real field experiments. Initially, trials were planned only for the public safety scenario with a focus on an indoor deployment. For the V2V use case, performance studies based on the OTAinVEE framework had been programmed. However, following the recommendation from the RESCUE reviewers suggesting to study the RESCUE architecture not only under synthesized traffic and propagation conditions but also to conduct real field experiments, the consortium deployed additional efforts for this purpose. Consequently, for both deployments the technical configuration and experimental test plan are detailed in this document. Whereby for the V2V setup one of the challenging parts was to integrate an efficient hence remote access to each mobile node in such a way that the individual measurements could be configured and started while the vehicles were moving. Numerous experiments have been conducted in particular for TS0 PHY and MAC as well as for TS1. However, other scenarios or more intense trials have been limited by the enormous time consumption of each single test to provide enough datasets fulfilling statistical means. The fourth part of D4.4 provides final assessments and conclusions. It aims to bridge the research and validation methods used within the RESCUE project and their subsequent performance results. The considered stages of performance validation balance between realism and simplification while moving from theory to practice. Results from three different WPs: WP2, WP3 as well as WP4 are discussed and related among each other. From the validation method perspective it can be concluded that this project was able to research the capabilities of the links-on-the-fly concept with a very ambitious approach bridging the ineluctable gap between theory and practice. It was found that the gains of this new architecture are impacted by the implementation of more practical-oriented validation methods of increasing complexity. A detailed analysis identifying the potential impact of the validation methodologies on the given results, e.g., the small number of nodes during the experiments or constraints by the software and hardware implementation and integration of the test platform, are left for future study