Herbal medicinal products or preparations for neuropathic pain.

BACKGROUND: Neuropathic pain is a consequence of damage to the central nervous system (CNS), for example, cerebrovascular accident, multiple sclerosis or spinal cord injury, or peripheral nervous system (PNS), for example, painful diabetic neuropathy (PDN), postherpetic neuralgia (PHN), or surgery. Evidence suggests that people suffering from neuropathic pain are likely to seek alternative modes of pain relief such as herbal medicinal products due to adverse events brought about by current pharmacological agents used to treat neuropathic pain. This review includes studies in which participants were treated with herbal medicinal products (topically or ingested) who had experienced neuropathic pain for at least three months. OBJECTIVES: To assess the analgesic efficacy and effectiveness of herbal medicinal products or preparations for neuropathic pain, and the adverse events associated with their use. SEARCH METHODS: We searched CENTRAL and the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL and AMED to March 2018. We identified additional studies from the reference lists of the retrieved papers. We also searched trials registries for ongoing trials and we contacted experts in the field for relevant data in terms of published, unpublished or ongoing studies. SELECTION CRITERIA: We included randomised controlled trials (including cross-over designs) of double-blind design, assessing efficacy of herbal treatments for neuropathic pain compared to placebo, no intervention or any other active comparator. Participants were 18 years and above and had been suffering from one or more neuropathic pain conditions, for three months or more.We applied no restrictions to language or gender. We excluded studies monitoring effects of isolated, single chemicals derived from the plant or synthetic chemicals based on constituents of the plant, if they were not administered at a concentration naturally present within the plant.We excluded studies monitoring the effects of traditional Asian medicine and Cannabinoids as well as studies looking at headache or migraine as these treatments and conditions are addressed in distinct reviews. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion, assessed risk of bias, and extracted data. We calculated the risk ratio (RR) and number needed to treat for an additional beneficial outcome (NNTB). The primary outcomes were participant-reported pain relief of 30%, or 50%, or greater, and participant-reported global impression of clinical change (PGIC). We also collected information on adverse events. We assessed evidence using GRADE and created a 'Summary of findings' table. MAIN RESULTS: We included two studies (128 participants). Both diabetic neuropathy and non-diabetic neuropathic pain conditions were investigated across these two studies.Two herbal medicinal products, namely nutmeg (applied topically as a 125 mL spray for four weeks, containing mace oil 2%, nutmeg oil 14%, methyl salicylate 6%, menthol 6%, coconut oil and alcohol) and St John's wort (taken in capsule form containing 900 µg total hypericin each, taken three times daily, giving a total concentration of 2700 mg for five weeks). Both studies allowed the use of concurrent analgesia.Both reported at least one pain-related outcome but we could not carry out meta-analysis of effectiveness due to heterogeneity between the primary outcomes and could not draw any conclusions of effect. Other outcomes included PGIC, adverse events and withdrawals. There were no data for participant-reported pain relief of 50% or greater or PGIC (moderate and substantial) outcomes.When looking at participant-reported pain relief of 30% or greater over baseline, we observed no evidence of a difference (P = 0.64) in response to nutmeg versus placebo (RR 1.12, 95% confidence interval (CI) 0.69 to 1.85; 48.6% vs 43.2%). We downgraded the evidence for this outcome to very low quality.We observed no change between placebo and nutmeg treatment when looking at secondary pain outcomes. Visual analogue scale (VAS) scores for pain reduction (0 to 100, where 0 = no pain reduction), were 44 for both nutmeg and placebo with standard deviations of 21.5 and 26.5 respectively. There was no evidence of a difference (P = 0.09 to 0.33) in total pain score in response to St John's wort compared to placebo, as there was only a reduction of 1 point when looking at median differences in change from baseline on a 0 to 10-point numeric rating scale.There was a total of five withdrawals out of 91 participants (5%) in the treatment groups compared to six of 91 (6.5%) in the placebo groups, whilst adverse events were the same for both the treatment and placebo groups.We judged neither study as having a low risk of bias. We attributed risk of bias to small study size and incomplete outcome data leading to attrition bias. We downgraded the evidence to very low quality for all primary and secondary outcomes reported in this review. We downgraded the quality of the evidence twice due to very serious limitations in study quality (due to small study size and attrition bias) and downgraded a further level due to indirectness as the included studies only measured outcomes at short-term time points. The results from this review should be treated with scepticism as we have very little confidence in the effect estimate. AUTHORS' CONCLUSIONS: There was insufficient evidence to determine whether nutmeg or St John's wort has any meaningful efficacy in neuropathic pain conditions.The quality of the current evidence raises serious uncertainties about the estimates of effect observed, therefore, we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

Evaluation of an E-Learning Training Program to Support Implementation of a Group-Based, Theory-Driven, Self-Management Intervention For Osteoarthritis and Low-Back Pain: Pre-Post Study.

BACKGROUND: By adaptation of the face-to-face physiotherapist-training program previously used in the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) feasibility trial, an asynchronous, interactive, Web-based, e-learning training program (E-SOLAS) underpinned by behavior and learning theories was developed. OBJECTIVE: This study investigated the effect of the E-SOLAS training program on relevant outcomes of effective training and implementation. METHODS: Thirteen physiotherapists from across Ireland were trained via E-SOLAS by using mixed methods, and seven physiotherapists progressed to implementation of the 6-week group-based SOLAS intervention. The effectiveness of E-SOLAS was evaluated using the Kirkpatrick model at the levels of reaction (physiotherapist engagement and satisfaction with E-SOLAS training methods and content), learning (pre- to posttraining changes in physiotherapists' confidence and knowledge in delivering SOLAS content and self-determination theory-based communication strategies, administered via a SurveyMonkey questionnaire), and behavior (fidelity to delivery of SOLAS content using physiotherapist-completed weekly checklists). During implementation, five physiotherapists audio recorded delivery of one class, and the communication between physiotherapists and clients was assessed using the Health Care Climate Questionnaire (HCCQ), the Controlling Coach Behaviour Scale (CCBS), and an intervention-specific measure (ISM; 7-point Likert scale). A range of implementation outcomes were evaluated during training and delivery (ie, acceptability, appropriateness, feasibility, fidelity, and sustainability of E-SOLAS) using a posttraining feedback questionnaire and individual semistructured telephone interviews. RESULTS: With regard to their reaction, physiotherapists (n=13) were very satisfied with E-SOLAS posttraining (median 5.0; interquartile range 1.0; min-max 4.0-5.0) and completed training within 3-4 weeks. With regard to learning, there were significant increases in physiotherapists' confidence and knowledge in delivery of all SOLAS intervention components (P<.05). Physiotherapists' confidence in 7 of 10 self-determination theory-based communication strategies increased (P<.05), whereas physiotherapists' knowledge of self-determination theory-based strategies remained high posttraining (P>.05). In terms of behavior, physiotherapists delivered SOLAS in a needs supportive manner (HCCQ: median 5.2, interquartile range 1.3, min-max 3.7-5.8; CCBS: median 6.6, interquartile range 1.0, min-max 5.6-7.0; ISM: median 4.5, interquartile range 1.2, min-max 2.8-4.8). Fidelity scores were high for SOLAS content delivery (total %mean fidelity score 93.5%; SD 4.9%). The posttraining questionnaire and postdelivery qualitative interviews showed that physiotherapists found E-SOLAS acceptable, appropriate, feasible, and sustainable within primary care services to support the implementation of the SOLAS intervention. CONCLUSIONS: This study provides preliminary evidence of the effectiveness, acceptability, and feasibility of an e-learning program to train physiotherapists to deliver a group-based self-management complex intervention in primary care settings, which is equivalent to face-to-face training outcomes and would support inclusion of physiotherapists in a definitive trial of SOLAS.

Communication Skills Training for Practitioners to Increase Patient Adherence to Home-Based Rehabilitation for Chronic Low Back Pain: Results of a Cluster Randomized Controlled Trial.

OBJECTIVE: To assess the effect of an intervention designed to enhance physiotherapists' communication skills on patients' adherence to recommendations regarding home-based rehabilitation for chronic low back pain. DESIGN: Cluster randomized controlled trial. SETTING: Publicly funded physiotherapy clinics. PARTICIPANTS: A sample (N=308) of physiotherapists (n=53) and patients with chronic low back pain (n=255; 54% female patients; mean age, 45.3y). INTERVENTIONS: Patients received publicly funded individual physiotherapy care. In the control arm, care was delivered by a physiotherapist who had completed a 1-hour workshop on evidence-based chronic low back pain management. Patients in the experimental arm received care from physiotherapists who had also completed 8 hours of communication skills training. MAIN OUTCOME MEASURES: (1) Patient-reported adherence to their physiotherapists' recommendations regarding home-based rehabilitation measured at 1, 4, 12, and 24 weeks after the initial treatment session. (2) Pain and pain-related function measured at baseline and at 4, 12, and 24 weeks. RESULTS: A linear mixed model analysis revealed that the experimental arm patients' ratings of adherence were higher than those of controls (overall mean difference, .41; 95% confidence interval, .10-.72; d=.28; P=.01). Moderation analyses revealed that men, regardless of the intervention, showed improvements in pain-related function over time. Only women in the experimental arm showed functional improvements; female controls showed little change in function over time. The Communication Style and Exercise Compliance in Physiotherapy intervention did not influence patients' pain, regardless of their sex. CONCLUSIONS: Communication skills training for physiotherapists had short-term positive effects on patient adherence. This training may provide a motivational basis for behavior change and could be a useful component in complex interventions to promote adherence. Communication skills training may also improve some clinical outcomes for women, but not for men.

Effect of a self-determination theory-based communication skills training program on physiotherapists' psychological support for their patients with chronic low back pain: a randomized controlled trial.

OBJECTIVE: To examine the effects of communication skills training on physiotherapists' supportive behavior during clinical practice. DESIGN: Randomized trial. SETTING: Hospital outpatient physiotherapy clinics. PARTICIPANTS: Physiotherapists (N=24) and patients (N=24) with chronic low back pain. INTERVENTIONS: Two hospital clinics were randomly assigned to the intervention arm. Physiotherapists (n=12) received 8 hours of communication skills training focused on supporting patients' psychological needs. Physiotherapists (n=12) from 2 other hospital clinics formed a waitlist control arm. MAIN OUTCOME MEASURES: Verbal communication between each physiotherapist and a patient was recorded on an audiotape, and independent, blinded raters used the Health Care Climate Questionnaire to assess physiotherapists' needs-supportive behavior (primary outcome). RESULTS: Independent raters' Health Care Climate Questionnaire scores favored the intervention arm (Cohen's d=2.27; P<.01). CONCLUSIONS: Compared with controls, independent ratings demonstrated that physiotherapists who completed the Communication style and exercise compliance in physiotherapy training were found to provide greater support for patients' needs in a single assessed session. Long-term maintenance of this needs-supportive behavior should be examined.

Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review.

OBJECTIVES: To identify measures of adherence to nonpharmacologic self-management treatments for chronic musculoskeletal (MSK) populations; and to report on the measurement properties of identified measures. DATA SOURCES: Five databases were searched for all study types that included a chronic MSK population, unsupervised intervention, and measure of adherence. STUDY SELECTION: Two independent researchers reviewed all titles for inclusion using the following criteria: adult (>18y) participants with a chronic MSK condition; intervention, including an unsupervised self-management component; and measure of adherence to the unsupervised self-management component. DATA EXTRACTION: Descriptive data regarding populations, unsupervised components, and measures of unsupervised adherence (items, response options) were collected from each study by 1 researcher and checked by a second for accuracy. DATA SYNTHESIS: No named or referenced adherence measurement tools were found, but a total of 47 self-invented measures were identified. No measure was used in more than a single study. Methods could be grouped into the following: home diaries (n=31), multi-item questionnaires (n=11), and single-item questionnaires (n=7). All measures varied in type of information requested and scoring method. The lack of established tools precluded quality assessment of the measurement properties using COnsensus-based Standards for the selection of health Measurement INstruments methodology. CONCLUSIONS: Despite the importance of adherence to self-management interventions, measurement appears to be conducted on an ad hoc basis. It is clear that there is no consistency among adherence measurement tools and that the construct is ill-defined. This study alerts the research community to the gap in measuring adherence to self-care in a rigorous and reproducible manner. Therefore, we need to address this gap by using credible methods (eg, COnsensus-based Standards for the selection of health Measurement INstruments guidelines) to develop and evaluate an appropriate measure of adherence for self-management.

Walking away from back pain: one step at a time - a community-based randomised controlled trial.

BACKGROUND: Low back pain is highly prevalent and a significant public health burden in Western society. Feasibility studies suggest personalised pedometer-driven walking is an acceptable and effective motivating tool in the management of chronic low back pain (CLBP ≥ 12 weeks). The proposed study will investigate pedometer-driven walking as a low cost, easily accessible, and sustainable means of physical activity to improve disability and clinical outcomes for people with CLBP in Saskatchewan, Canada. METHODS/DESIGN: A fully-powered single-blinded randomised controlled trial will compare back care advice and education with back care advice and education followed by a 12-week pedometer-driven walking programme in adults with CLBP. Adults with self-reported CLBP will be recruited from the community and screened for elibility. Two-hundred participants will be randomly allocated to one of two intervention groups. All participants will receive a single back care advice and education session with a physiotherapist. Participants in the walking group will also receive a physiotherapist-facilitated pedometer based walking programme. The physiotherapist will facilitate the participant to monitor and progress the walking programme, by phone, on a weekly basis over 10 weeks following two face-to-face sessions. Outcome measures of self-reported disability, physical activity, participants' low back pain beliefs/perceptions, quality of life and direct/indirect cost estimates will be gathered at baseline, three months, six months, and 12 months by a different physiotherapist blinded to group allocation. Following intervention, focus groups will be used to explore participants' thoughts and experiences of pedometer-driven walking as a management tool for CLBP. DISCUSSION: This paper describes the design of a community-based RCT to determine the effectiveness of a pedometer-driven walking programme in the management of CLBP. TRIAL REGISTRATION: United States National Institutes of Health Clinical Trails registry (http://ClinicalTrials.gov/) No. NCT02284958 . Registered on 27(th) October 2014).

A brief report on the development of a theoretically-grounded intervention to promote patient autonomy and self-management of physiotherapy patients: face validity and feasibility of implementation.

BACKGROUND: Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient's motivation and maintenance of self-management behaviours can be positively influenced by the clinician's use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. METHODS: A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. RESULTS: Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. CONCLUSION: The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.

Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). DESIGN: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. SETTING: Outpatient physiotherapy department in an academic teaching hospital. PARTICIPANTS: Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation. INTERVENTIONS: Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise). MAIN OUTCOME MEASURES: Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy. RESULTS: Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2-0.5). CONCLUSIONS: The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial.

Does a patient's physical activity predict recovery from an episode of acute low back pain? A prospective cohort study.

BACKGROUND: Advice to remain active and normalisation of activity are commonly prescribed in the management of low back pain (LBP). However, no research has assessed whether objective measurements of physical activity predict outcome and recovery in acute low back pain. METHOD: The aims of this study were to assess the predictive relationship between activity and disability at 3 months in a sub-acute LBP population. This prospective cohort study recruited 101 consenting patients with sub-acute LBP (< 6 weeks) who completed the Roland Morris Disability Questionnaire (RMDQ), the Visual Analogue Scale, and resumption of full 'normal' activity question (Y/N), at baseline and 3 months. Physical activity was measured for 7 days at both baseline and at 3 months with an RT3 accelerometer and a recall questionnaire. RESULTS: Observed and self-reported measures of physical activity at baseline and change in activity from baseline to 3 months were not independent predictors of RMDQ (p > 0.05) or RMDQ change (p > 0.05) over 3 months. A self-report of a return to full 'normal' activities was significantly associated with greater RMDQ change score at 3 months (p < 0.001). Paired t-tests found no significant change in activity levels measured with the RT3 (p = 0.57) or the recall questionnaire (p = 0.38) from baseline to 3 months. CONCLUSIONS: These results question the predictive role of physical activity in LBP recovery, and the assumption that activity levels change as LBP symptoms resolve. The importance of a patient's perception of activity limitation in recovery from acute LBP was also highlighted. TRIAL REGISTRATION: Clinical Trial Registration Number, ACTRN12609000282280.

Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized controlled trial.

OBJECTIVE: To investigate the effectiveness of low-level laser therapy (LLLT) as an adjunct to a program of eccentric exercises for the treatment of Achilles' tendinopathy. DESIGN: Randomized controlled trial with evaluations at baseline and 4, 12, and 52 weeks. SETTING: Primary care clinic. PARTICIPANTS: Participants with midportion Achilles' tendinopathy were randomly assigned to 2 groups (LLLT n=20: mean age ± SD, 45.6±9.1y; placebo n=20: mean age ± SD, 46.5±6.4y). The 12-week evaluation was completed by 36 participants (90%), and 33 participants (82.5%) completed the 52-week evaluation. INTERVENTION: Both groups of participants performed eccentric exercises over a 3-month period. In addition, they received either an active or placebo application of LLLT 3 times per week for the first 4 weeks; the dose was 3J per point. MAIN OUTCOME MEASURES: The primary outcome was the Victorian Institute of Sport Assessment-Achilles' questionnaire (VISA-A) score at 12 weeks; secondary outcome was a visual analog scale for pain. Outcomes were measured at baseline and 4, 12, and 52 weeks. RESULTS: Baseline characteristics exhibited no differences between groups. At the primary outcome point, there was no statistically significant difference in VISA-A scores between groups (P>.05). The difference in VISA-A scores at the 4-week point significantly favored the placebo group (F(1)=6.411, sum of squares 783.839; P=.016); all other outcome scores showed no significant difference between the groups at any time point. Observers were blinded to groupings. CONCLUSIONS: The clinical effectiveness of adding LLLT to eccentric exercises for the treatment of Achilles' tendinopathy has not been demonstrated using the parameters in this study.

Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients' adherence to physiotherapists' recommendations: study rationale, design, and methods.

BACKGROUND: Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist's recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients' autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists' recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists' autonomy-supportive communication on low back pain patients' adherence to physical activity and exercise therapy recommendations. METHODS/DESIGN: This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded.We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. DISCUSSION: This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients' adherence to rehabilitation recommendations.

Comparing an e-Health program vs home rehabilitation program in patients with non-specific low back pain: A study protocol randomized feasibility trial.

BACKGROUND: There is little evidence on the reliability of the web application-based rehabilitation systems to treat chronic low back pain (CLBP). METHODS: This protocol describes a double-blind, randomized controlled feasibility trial of an e-Health intervention developed to support the self-management of people with CLBP in primary care physiotherapy. Three Hospitals with primary care for outpatients will be the units of randomisation, in each Hospital the participants will be randomized to one of two groups, a pragmatic control group receiving either the usual home program based on electrostimulation and McKenzie Therapy and e-Health intervention. Patients are followed up at 2 and 6 months. The primary outcomes are (1) acceptability and demand of the intervention by GPs, physiotherapists and patients and (2) feasibility and optimal study design/methods for a definitive trial. Secondary outcomes will include analysis in the clinical outcomes of pain, disability, fear of movement, quality of life, isometric resistance of the trunk flexors, lumbar anteflexion and lumbar segmental range of motion. DISCUSSION: The specific e-Health programs to home could increase adherence to treatment, prevent stages of greater pain and disability, and improve the painful symptomatology. CONCLUSIONS: The e-Health programs could be an effective healthcare tool that can reach a large number of people living in rural or remote areas.

Objective measurements of sleep for non-laboratory settings as alternatives to polysomnography--a systematic review.

Sleep disturbance influences human health. To examine sleep patterns, it is advisable to utilize valid subjective and objective measures. Laboratory-based polysomnography (PSG) is deemed the gold standard to measure sleep objectively, but is impractical for long-term and home utilization (e.g. resource-demanding, difficult to use). Hence, alternative devices have been developed. This study aimed to review the literature systematically, providing an overview of available objective sleep measures in non-laboratory settings as an alternative to PSG. To identify relevant articles, a specific search strategy was run in EMBASE, PubMed, CINAHL, PsycInfo and Compendex (Engineering Village 2). In addition, reference lists of retrieved articles were screened and experts within this research field were contacted. Two researchers, using specified in/exclusion criteria, screened identified citations independently in three stages: on title, abstract and full text. Data from included articles were extracted and inserted into summarizing tables outlining the results. Of the 2217 electronically identified citations, 35 studies met the inclusion criteria. Additional searches revealed eight papers. Psychometric characteristics of nine different objective measures of sleep pattern alternatives to PSG [(bed) actigraphy, observation, bed sensors, eyelid movement- and non-invasive arm sensors, a sleep switch and a remote device] were evaluated. Actigraphy is used widely and has been validated in several populations. Alternative devices to measure sleep patterns are becoming available, but most remain at prototype stage and are validated insufficiently. Future research should concentrate on the development and further validation of non-invasive, inexpensive and user-friendly sleep measures for non-laboratory settings.

Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain.

(1) Background: Using new technologies to manage home exercise programmes is an approach that allows more patients to benefit from therapy. The objective of this study is to explore physical therapists' opinions of the efficacy and disadvantages of implementing a web-based telerehabilitation programme for treating chronic low back pain (CLBP). (2) Methods: Nineteen physical therapists from academic and healthcare fields in both the public and private sector participated in the qualitative study. Texts extracted from a transcript of semi-structured, individual, in-depth interviews with each consenting participant were analysed to obtain the participants' prevailing opinions. The interviews lasted approximately 40 min each. The participants' responses were recorded. (3) Results: The results suggest that telerehabilitation can only be successful if patients become actively involved in their own treatment. However, exercise programmes for LBP are not always adapted to patient preferences. New technologies allow physical therapists to provide their patients with the follow-up and remote contact they demand, but long-term adherence to treatment stems from knowledge of the exercises and the correct techniques employed by the patients themselves. (4) Conclusions: Physical therapists treating patients with chronic non-specific low back pain believe that new technologies can provide highly effective means of reaching a greater number of patients and achieving significant savings in healthcare costs, despite the limitations of a telerehabilitation approach in developing an appropriate and effective patient-based physiotherapy programme.

The back 2 activity trial: education and advice versus education and advice plus a structured walking programme for chronic low back pain.

BACKGROUND: Current evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active. METHODS/DESIGN: The proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial. DISCUSSION: This paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain. TRIAL REGISTRATION: [ISRCTN67030896].

Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial.

BACKGROUND: Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. METHODS/DESIGN: This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data). DISCUSSION: This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. TRIAL REGISTRATION: Current controlled trial ISRCTN54009836.

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).

BACKGROUND: The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. METHODS: This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants' cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. RESULTS: Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD) = 4.92 (1.31), range 2-7; UP: mean (SD) = 5.08 (2.43), range 1-9). One hundred twenty participants (83.3% of n = 144 expected) were recruited (intervention n = 59; UP n = 61), with follow-up data obtained from 80.8% (n = 97) at 6 weeks, 84.2% (n = 101) at 2 months and 71.7% (n = 86) at 6 months. Most participants received treatment as allocated (intervention n = 49; UP n = 54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between-group effects. CONCLUSIONS: While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. TRIAL REGISTRATION: ISRCTN ISRCTN49875385 . Registered on 26 March 2014.

Objective and subjective assessment of sleep in chronic low back pain patients compared with healthy age and gender matched controls: a pilot study.

BACKGROUND: While approximately 70% of chronic low back pain (CLBP) sufferers complain of sleep disturbance, current literature is based on self report measures which can be prone to bias and no objective data of sleep quality, based exclusively on CLBP are available. In accordance with the recommendations of The American Sleep Academy, when measuring sleep, both subjective and objective assessments should be considered as the two are only modestly correlated, suggesting that each modality assesses different aspects of an individual's sleep experience. Therefore, the purpose of this study was to expand previous research into sleep disturbance in CLBP by comparing objective and subjective sleep quality in participants with CLBP and healthy age and gender matched controls, to identify correlates of poor sleep and to test logistics and gather information prior to a larger study. METHODS: 15 CLBP participants (mean age = 43.8 years (SD = 11.5), 53% female) and 15 healthy controls (mean age = 41.5 years (SD = 10.6), 53% female) consented. All participants completed the Pittsburgh Sleep Quality Index, Insomnia Severity Index, Pittsburgh Sleep Diary and the SF36v2. CLBP participants also completed the Oswestry Disability Index. Sleep patterns were assessed over three consecutive nights using actigraphy. Total sleep time (TST), sleep efficiency (SE), sleep latency onset (SL) and number of awakenings after sleep onset (WASO) were derived. Statistical analysis was conducted using unrelated t-tests and Pearson's product moment correlation co-efficients. RESULTS: CLBP participants demonstrated significantly poorer overall sleep both objectively and subjectively. They demonstrated lower actigraphic SE (p = .002) and increased WASO (p = .027) but no significant differences were found in TST (p = .43) or SL (p = .97). Subjectively, they reported increased insomnia (p =< .001), lower SE (p =< .001) and increased SL (p =< .001) but no difference between TST (p = .827) and WASO (p = .055). Statistically significant associations were found between low back pain (p = .021, r = -.589), physical health (p = .003, r = -.713), disability levels (p = .025, r = .576), and subjective sleep quality in the CLBP participants but not with actigraphy. CONCLUSION: CLBP participants demonstrated poorer overall sleep, increased insomnia symptoms and less efficient sleep. Further investigation using a larger sample size and a longer period of sleep monitoring is ongoing.

Does physical activity change predict functional recovery in low back pain? Protocol for a prospective cohort study.

BACKGROUND: Activity advice and prescription are commonly used in the management of low back pain (LBP). Although there is evidence for advising patients with LBP to remain active, facilitating both recovery and return to work, to date no research has assessed whether objective measurements of free living physical activity (PA) can predict outcome, recovery and course of LBP. METHODS: An observational longitudinal study will investigate PA levels in a cohort of community-dwelling working age adults with acute and sub-acute LBP. Each participant's PA level, functional status, mood, fear avoidance behaviours, and levels of pain, psychological distress and occupational activity will be measured on three occasions during for 1 week periods at baseline, 3 months, and 1 year. Physical activity levels will be measured by self report, RT3 triaxial accelerometer, and activity recall questionnaires. The primary outcome measure of functional recovery will be the Roland Morris Disability Questionnaire (RMDQ). Free living PA levels and changes in functional status will be quantified in order to look at predictive relationships between levels and changes in free living PA and functional recovery in a LBP population. DISCUSSION: This research will investigate levels and changes in activity levels of an acute LBP cohort and the predictive relationship to LBP recovery. The results will assess whether occupational, psychological and behavioural factors affect the relationship between free living PA and LBP recovery. Results from this research will help to determine the strength of evidence supporting international guidelines that recommend restoration of normal activity in managing LBP. TRIAL REGISTRATION: [Clinical Trial Registration Number, ACTRN12609000282280].

A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial).

BACKGROUND: Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven. METHODS AND DESIGN: This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research design to obtain feedback about participants' experiences of the interventions and trial participation, and to inform interpretation of the quantitative data. Planned analysis will be by intention to treat (quantitative data) and thematic analysis (qualitative data) DISCUSSION: The trial will evaluate the effectiveness of a walking programme and a supervised general exercise programme compared to usual physiotherapy in people with CLBP. TRIAL REGISTRATION: Current controlled trial ISRCTN17592092.