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.

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.

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.

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.

Assessing physiotherapists' communication skills for promoting patient autonomy for self-management: reliability and validity of the communication evaluation in rehabilitation tool.

PURPOSE: To assess the inter-rater reliability and concurrent validity of the Communication Evaluation in Rehabilitation Tool, which aims to externally assess physiotherapists competency in using Self-Determination Theory-based communication strategies in practice. MATERIALS AND METHODS: Audio recordings of initial consultations between 24 physiotherapists and 24 patients with chronic low back pain in four hospitals in Ireland were obtained as part of a larger randomised controlled trial. Three raters, all of whom had Ph.Ds in psychology and expertise in motivation and physical activity, independently listened to the 24 audio recordings and completed the 18-item Communication Evaluation in Rehabilitation Tool. Inter-rater reliability between all three raters was assessed using intraclass correlation coefficients. Concurrent validity was assessed using Pearson's r correlations with a reference standard, the Health Care Climate Questionnaire. RESULTS: The total score for the Communication Evaluation in Rehabilitation Tool is an average of all 18 items. Total scores demonstrated good inter-rater reliability (Intraclass Correlation Coefficient (ICC) = 0.8) and concurrent validity with the Health Care Climate Questionnaire total score (range: r = 0.7-0.88). Item-level scores of the Communication Evaluation in Rehabilitation Tool identified five items that need improvement. CONCLUSION: Results provide preliminary evidence to support future use and testing of the Communication Evaluation in Rehabilitation Tool. Implications for Rehabilitation Promoting patient autonomy is a learned skill and while interventions exist to train clinicians in these skills there are no tools to assess how well clinicians use these skills when interacting with a patient. The lack of robust assessment has severe implications regarding both the fidelity of clinician training packages and resulting outcomes for promoting patient autonomy. This study has developed a novel measurement tool Communication Evaluation in Rehabilitation Tool and a comprehensive user manual to assess how well health care providers use autonomy-supportive communication strategies in real world-clinical settings. This tool has demonstrated good inter-rater reliability and concurrent validity in its initial testing phase. The Communication Evaluation in Rehabilitation Tool can be used in future studies to assess autonomy-supportive communication and undergo further measurement property testing as per our recommendations.

An assessment of physiotherapist's delivery of behaviour change techniques within the SOLAS feasibility trial.

OBJECTIVES: To investigate physiotherapist's (PTs) fidelity to 31 protocol-listed behaviour change techniques (BCTs) during a group-based self-management intervention. This study also explored the PTs delivery of these BCTs beyond the present or absent dichotomy, using a third variable, partial delivery (i.e., attempted). DESIGN: Assessment of the intervention arm of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) cluster, randomized controlled feasibility trial, using quantitative methods. METHODS: Eight PTs delivered six SOLAS classes each, of which 50% were audio-recorded and transcribed. Transcripts were coded by two raters using the Behaviour Change Technique Taxonomy v1 and an intervention-specific manual and assessed for the delivery (i.e., full, partial, or absent) of the 31 BCTs and their target behaviours. Fidelity was calculated as fully delivered BCTs listed as a percentage of those due to take place within each class. RESULTS: Physiotherapists delivered a mean 20.5 BCTs per class (68.3%; range = 64.9-72.4%). Of these, 17 BCTs were fully delivered in each class representing moderate fidelity to the protocol (56.8%; range = 53.5-59.3%). A further 3.5 BCTs per class (11.5%; range = 8.7-14.8%) were partially delivered. BCTs associated with 'goals and planning' were often poorly delivered. CONCLUSIONS: Delivering the SOLAS intervention BCTs with high fidelity was not feasible. The assessment of partial delivery of BCTs provided greater insight into the techniques that should be removed from the protocol or that may require further training. Complex interventions should consider a list of 'core' or mandatory BCTs alongside 'optional' BCTs, depending on the target behaviour, and the needs of individual participants. Statement of contribution What is already known on this subject? BCTs are the smallest active components of behavioural interventions, yet typically their effectiveness is determined through meta-analyses. Attempted delivery of BCTs is often unaccounted for yet may provide valuable insight into difficulty with delivery. There is a need to investigate BCT implementation beyond simple presence/absence to identify protocol refinements or required BCT training. What does this study add? BCT delivery was assessed in greater depth than previous research, including partial delivery. Highlights the need for appropriate training in BCTs that are difficult to deliver, particularly those associated with 'goals and planning' Highlights the need for intervention-specific criteria as to what constitutes 'high', 'moderate', and 'low' fidelity.

Feasibility of Training Physical Therapists to Deliver the Theory-Based Self-Management of Osteoarthritis and Low Back Pain Through Activity and Skills (SOLAS) Intervention Within a Trial.

Background: Provider training programs are frequently underevaluated, leading to ambiguity surrounding effective intervention components. Objective: The purpose of this study was to assess the effectiveness of a training program in guiding physical therapists to deliver the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) group education and exercise intervention (ISRCTN49875385), using a communication style underpinned by self-determination theory (SDT). Design: This was an assessment of the intervention arm training program using quantitative methods. Methods: Thirteen physical therapists were trained using mixed methods to deliver the SOLAS intervention. Training was evaluated using the Kirkpatrick model: (1) Reaction-physical therapists' satisfaction with training, (2) Learning-therapists' confidence in and knowledge of the SDT-based communication strategies and intervention content and their skills in applying the strategies during training, and (3) Behavior-8 therapists were audio-recorded delivering all 6 SOLAS intervention classes (n = 48), and 2 raters independently coded 50% of recordings (n = 24) using the Health Care Climate Questionnaire (HCCQ), the Controlling Coach Behavior Scale (CCBS), and an intervention-specific measure. Results: Reaction: Physical therapists reacted well to training (median [IRQ]; min-max = 4.7; [0.5]; 3.7-5.0). Learning: Physical therapists' confidence in the SDT-based communication strategies and knowledge of some intervention content components significantly improved. Behavior: Therapists delivered the intervention in a needs-supportive manner (median HCCQ = 5.3 [1.4]; 3.9-6.0; median CCBS = 6.6 ([0.5]; 6.1-6.8; median intervention specific measure = 4.0 [1.2]; 3.2-4.9). However, "goal setting" was delivered below acceptable levels by all therapists (median 2.9 [0.9]; 2.0-4.0). Limitations: The intervention group only was assessed as part of the process evaluation of the feasibility trial. Conclusions: Training effectively guided physical therapists to be needs-supportive during delivery of the SOLAS intervention. Refinements were outlined to improve future similar training programs, including greater emphasis on goal setting.

Systematic Review of Costs and Effects of Self-Management Interventions for Chronic Musculoskeletal Pain: Spotlight on Analytic Perspective and Outcomes Assessment.

Background: Evidence for the cost-effectiveness of self-management interventions for chronic musculoskeletal pain (CMP) lacks consensus, which may be due to variability in the costing methods employed. Purpose: The purposes of the study were to identify how costs and effects have been assessed in economic analysis of self-management interventions for CMP and to identify the effect of the chosen analytical perspective on cost-effectiveness conclusions. Data Sources: Five databases were searched for all study designs using relevant terms. Study Selection: Two independent researchers reviewed all titles for predefined inclusion criteria: adults (≥18 years of age) with CMP, interventions with a primary aim of promoting self-management, and conducted a cost analysis. Data Extraction: Descriptive data including population, self-management intervention, analytical perspective, and costs and effects measured were collected by one reviewer and checked for accuracy by a second reviewer. Data Synthesis: Fifty-seven studies were identified: 65% (n = 37) chose the societal perspective, of which 89% (n = 33) captured health care utilization, 92% (n = 34) reported labor productivity, 65% (n = 24) included intervention delivery, and 59% (n = 22) captured patient/family costs. Types of costs varied in all studies. Eight studies conducted analyses from both health service and societal perspectives; cost-effectiveness estimates varied with perspective chosen, but in no case was the difference sufficient to change overall policy recommendations. Limitations: Chronic musculoskeletal pain conditions where self-management is recommended, but not as a primary treatment, were excluded. Gray literature was excluded. Conclusion: Substantial heterogeneity in the cost components captured in the assessment of self-management for CMP was found; this was independent of the analytic perspective used. Greater efforts to ensure complete and consistent costings are required if reliable cost-effectiveness evidence of self-management interventions is to be generated and to inform the most appropriate perspective for economic analyses in this field.

Using mixed methods to assess fidelity of delivery and its influencing factors in a complex self-management intervention for people with osteoarthritis and low back pain.

OBJECTIVES AND DESIGN: Despite an increasing awareness of the importance of fidelity of delivery within complex behaviour change interventions, it is often poorly assessed. This mixed methods study aimed to establish the fidelity of delivery of a complex self-management intervention and explore the reasons for these findings using a convergent/triangulation design. SETTING: Feasibility trial of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention (ISRCTN49875385), delivered in primary care physiotherapy. METHODS AND OUTCOMES: 60 SOLAS sessions were delivered across seven sites by nine physiotherapists. Fidelity of delivery of prespecified intervention components was evaluated using (1) audio-recordings (n=60), direct observations (n=24) and self-report checklists (n=60) and (2) individual interviews with physiotherapists (n=9). Quantitatively, fidelity scores were calculated using percentage means and SD of components delivered. Associations between fidelity scores and physiotherapist variables were analysed using Spearman's correlations. Interviews were analysed using thematic analysis to explore potential reasons for fidelity scores. Integration of quantitative and qualitative data occurred at an interpretation level using triangulation. RESULTS: Quantitatively, fidelity scores were high for all assessment methods; with self-report (92.7%) consistently higher than direct observations (82.7%) or audio-recordings (81.7%). There was significant variation between physiotherapists' individual scores (69.8% - 100%). Both qualitative and quantitative data (from physiotherapist variables) found that physiotherapists' knowledge (Spearman's association at p=0.003) and previous experience (p=0.008) were factors that influenced their fidelity. The qualitative data also postulated participant-level (eg, individual needs) and programme-level factors (eg, resources) as additional elements that influenced fidelity. CONCLUSION: The intervention was delivered with high fidelity. This study contributes to the limited evidence regarding fidelity assessment methods within complex behaviour change interventions. The findings suggest a combination of quantitative methods is suitable for the assessment of fidelity of delivery. A mixed methods approach provided a more insightful understanding of fidelity and its influencing factors. TRIAL REGISTRATION NUMBER: ISRCTN49875385; Pre-results.

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.

Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS).

BACKGROUND: The Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system. METHODS: The six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory. RESULTS: The SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback. CONCLUSIONS: The SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

Development of a Feasible Implementation Fidelity Protocol Within a Complex Physical Therapy-Led Self-Management Intervention.

BACKGROUND: Implementation fidelity is poorly addressed within physical therapy interventions, which may be due to limited research on how to develop and implement an implementation fidelity protocol. OBJECTIVE: The purpose of this study was to develop a feasible implementation fidelity protocol within a pilot study of a physical therapy-led intervention to promote self-management for people with chronic low back pain or osteoarthritis. DESIGN: A 2-phase mixed-methods design was used. METHODS: Phase 1 involved the development of an initial implementation fidelity protocol using qualitative interviews with potential stakeholders to explore the acceptability of proposed strategies to enhance and assess implementation fidelity. Phase 2 involved testing and refining the initial implementation fidelity protocol to develop a finalized implementation fidelity protocol. Specifically, the feasibility of 3 different strategies (physical therapist self-report checklists, independently rated direct observations, and audio-recorded observations) for assessing implementation fidelity of intervention delivery was tested, followed by additional stakeholder interviews that explored the overall feasibility of the implementation fidelity protocol. RESULTS: Phase 1 interviews determined the proposed implementation fidelity strategies to be acceptable to stakeholders. Phase 2 showed that independently rated audio recordings (n=6) and provider self-report checklists (n=12) were easier to implement than independently rated direct observations (n=12) for assessing implementation fidelity of intervention delivery. Good agreement (79.8%-92.8%) was found among all methods. Qualitative stakeholder interviews confirmed the acceptability, practicality, and implementation of the implementation fidelity protocol. LIMITATIONS: The reliability and validity of assessment checklists used in this study have yet to be fully tested, and blinding of independent raters was not possible. CONCLUSIONS: A feasible implementation fidelity protocol was developed based on a 2-phase development process involving intervention stakeholders. This study provides valuable information on the feasibility of rigorously addressing implementation fidelity within physical therapy interventions and provides recommendations for researchers wanting to address implementation fidelity in similar areas.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

INTRODUCTION: International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. METHODS/ANALYSIS: This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. ETHICS/DISSEMINATION: This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. TRIAL REGISTRATION NUMBER: ISRCTN 49875385; Pre-results.

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.

A review of behaviour change theories and techniques used in group based self-management programmes for chronic low back pain and arthritis.

BACKGROUND: Medical Research Council (MRC) guidelines recommend applying theory within complex interventions to explain how behaviour change occurs. Guidelines endorse self-management of chronic low back pain (CLBP) and osteoarthritis (OA), but evidence for its effectiveness is weak. OBJECTIVE: This literature review aimed to determine the use of behaviour change theory and techniques within randomised controlled trials of group-based self-management programmes for chronic musculoskeletal pain, specifically CLBP and OA. METHODS: A two-phase search strategy of electronic databases was used to identify systematic reviews and studies relevant to this area. Articles were coded for their use of behaviour change theory, and the number of behaviour change techniques (BCTs) was identified using a 93-item taxonomy, Taxonomy (v1). RESULTS: 25 articles of 22 studies met the inclusion criteria, of which only three reported having based their intervention on theory, and all used Social Cognitive Theory. A total of 33 BCTs were coded across all articles with the most commonly identified techniques being 'instruction on how to perform the behaviour', 'demonstration of the behaviour', 'behavioural practice', 'credible source', 'graded tasks' and 'body changes'. CONCLUSION: Results demonstrate that theoretically driven research within group based self-management programmes for chronic musculoskeletal pain is lacking, or is poorly reported. Future research that follows recommended guidelines regarding the use of theory in study design and reporting is warranted.

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).

Supervised walking in comparison with fitness training for chronic back pain in physiotherapy: results of the SWIFT single-blinded randomized controlled trial (ISRCTN17592092).

Effectiveness of brief/minimal contact self-activation interventions that encourage participation in physical activity (PA) for chronic low back pain (CLBP >12 weeks) is unproven. The primary objective of this assessor-blinded randomized controlled trial was to investigate the difference between an individualized walking programme (WP), group exercise class (EC), and usual physiotherapy (UP, control) in mean change in functional disability at 6 months. A sample of 246 participants with CLBP aged 18 to 65 years (79 men and 167 women; mean age ± SD: 45.4 ± 11.4 years) were recruited from 5 outpatient physiotherapy departments in Dublin, Ireland. Consenting participants completed self-report measures of functional disability, pain, quality of life, psychosocial beliefs, and PA were randomly allocated to the WP (n = 82), EC (n = 83), or UP (n = 81) and followed up at 3 (81%; n = 200), 6 (80.1%; n = 197), and 12 months (76.4%; n = 188). Cost diaries were completed at all follow-ups. An intention-to-treat analysis using a mixed between-within repeated-measures analysis of covariance found significant improvements over time on the Oswestry Disability Index (Primary Outcome), the Numerical Rating Scale, Fear Avoidance-PA scale, and the EuroQol EQ-5D-3L Weighted Health Index (P < 0.05), but no significant between-group differences and small between-group effect sizes (WP: mean difference at 6 months, 6.89 Oswestry Disability Index points, 95% confidence interval [CI] -3.64 to -10.15; EC: -5.91, CI: -2.68 to -9.15; UP: -5.09, CI: -1.93 to -8.24). The WP had the lowest mean costs and the highest level of adherence. Supervised walking provides an effective alternative to current forms of CLBP management.

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.