Reinforcing informed medication prescription for low back pain in the emergency department (RIME): a controlled interrupted time series implementation study protocol.

INTRODUCTION: Management guidelines for low back pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation and patient education. An audit in a large metropolitan hospital emergency department (ED) revealed high rates of non-recommended medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepines), high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation (on average 6 hours) and inadequate patient education (48% of patients). This study aims to improve medication prescription for LBP in this ED by implementing an intervention shown previously to improve guideline-based management of LBP in other Australian EDs. METHODS AND ANALYSIS: A controlled interrupted time series study will evaluate the intervention in the ED before (24 weeks; 20 March 2023-3 September 2023) and after (24 weeks; 27 November 2024-12 May 2024) implementation (12 weeks; 4 September 2023-26 November 2023), additionally comparing findings with another ED in the same health service. The multicomponent implementation strategy uses a formalised clinical flow chart to support clinical decision-making and aims to change clinician behaviour, through clinician education, provision of alternative treatments, educational resources, audit and feedback, supported by implementation champions. The primary outcome is the percentage of LBP patients prescribed non-recommended medications (opioids, benzodiazepines and/or gabapentinoids), assessed via routinely collected ED data. Anticipated sample size is 2000 patients (n=1000 intervention, n=1000 control) based on average monthly admissions of LBP presentations in the EDs. Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, representation to the ED within 6 months and healthcare costs. In nested qualitative research, we will study ED clinicians' perceptions of the implementation and identify how benefits can be sustained over time. ETHICS AND DISSEMINATION: This study received ethical approval from the Metro North Human Research Ethics Committee (HREC/2022/MNHA/87995). Study findings will be published in peer-reviewed journals and presented at international conferences and educational workshops. TRIAL REGISTRATION NUMBER: ACTRN12622001536752.

Do the effects of acupuncture vary between acupuncturists? Analysis of the Acupuncture Trialists' Collaboration individual patient data meta-analysis.

OBJECTIVES: The degree to which the effects of acupuncture treatment vary between acupuncturists is unknown. We used a large individual patient dataset of trials of acupuncture for chronic pain to assess practitioner heterogeneity. METHODS: Individual patient data linked to identifiable acupuncturists were drawn from a dataset of 39 high-quality trials of acupuncture, where the comparators were either sham acupuncture or non-acupuncture controls, such as standard care or waitlist. Heterogeneity among acupuncturists was assessed by meta-analysis. RESULTS: A total of 1206 acupuncturists in 13 trials were included. Statistically significant heterogeneity was found in trials with sham-control groups (p < 0.0001) and non-acupuncture control groups (p <0.0001). However, the degree of heterogeneity was very small, with the observed distribution of treatment effects virtually overlapping that expected by chance. For instance, for non-acupuncture-controlled trials, the proportion of acupuncturists with effect sizes half a standard deviation greater or less than average was expected to be 34%, but was observed to be 37%. A limitation is that the trials included a relatively limited range of acupuncturists, mainly physician-acupuncturists. DISCUSSION: Although differences in effects between acupuncturists were greater than expected by chance, the degree of variation was small. This suggests that most chronic pain patients in clinical practice would have similar results to those reported in high-quality trials; comparably, we did not find evidence to suggest that greater standardization of acupuncture practice would improve outcomes. Further research needs to be conducted exploring variability using a sample of acupuncturists with a broader range of practice styles, training and experience.

Identifying patients with chronic pain who respond to acupuncture: results from an individual patient data meta-analysis.

BACKGROUND: In a recent individual patient data meta-analysis, acupuncture was found to be superior to sham and non-sham controls in patients with chronic pain. It has been suggested that a subgroup of patients has an exceptional response to acupuncture. We hypothesized the presence of exceptional acupuncture responders would lead to a different distribution of pain scores in acupuncture versus control groups, with the former being skewed to the right. METHODS: This individual patient data meta-analysis included 39 high-quality randomized trials of acupuncture for chronic headache, migraine, osteoarthritis, low back pain, neck pain and shoulder pain published before December 2015 (n = 20,827). In all, 25 involved sham acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). We analyzed the distribution of change scores and calculated the difference in the skewness statistic-which assesses asymmetry in the data distribution-between acupuncture and either sham or non-acupuncture control groups. We then entered the difference in skewness along with standard error into a meta-analysis. FINDINGS: Control groups were more right-skewed than acupuncture groups, although this difference was very small. The difference in skew was 0.124 for non-acupuncture-controlled trials (p = 0.047) and 0.141 for sham-controlled trials (p = 0.029). In a pre-specified sensitivity analysis excluding three trials with outlying results known a priori, the difference in skew between acupuncture and sham was no longer statistically significant (p = 0.2). CONCLUSION: We did not find evidence to support the notion that there are exceptional acupuncture responders. The challenge remains to identify features of chronic pain patients that can be used to distinguish those that have a good response to acupuncture treatment.

The effect of an integrated multidisciplinary rehabilitation programme alternating inpatient interventions with home-based activities for patients with chronic low back pain: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness of an integrated rehabilitation programme with an existing rehabilitation programme in patients with chronic low back pain. DESIGN: A single-centre, pragmatic, two-arm parallel, randomized controlled trial (1:1 ratio). SETTING: A rheumatology inpatient rehabilitation centre in Denmark. SUBJECTS: A total of 165 adults (aged ⩾ 18 years) with chronic low back pain. INTERVENTIONS: An integrated rehabilitation programme comprising an alternation of three weeks of inpatient stay and 12 weeks of home-based activities was compared with an existing rehabilitation programme of four weeks of inpatient stay. MAIN MEASURES: Patient-reported outcomes were collected at baseline and at the 26-week follow-up. The primary outcome was back-specific disability (Oswestry Disability Index). Secondary outcomes included pain intensity (Numerical Rating Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire), health-related quality of life (EuroQol-5 Domain 5-level (EQ-5D)), and depression (Major Depression Inventory). A complete case analysis was performed. RESULTS: A total of 303 patients were assessed for eligibility of whom 165 (mean age: 50 years (SD 13) and mean Oswestry Disability Index score 42 (SD 11)) were randomized (83 to existing rehabilitation programme and 82 to integrated rehabilitation programme). Overall, 139 patients provided the 26-week follow-up data. Baseline demographic and clinical characteristics were comparable between programmes. The between-group difference in the Oswestry Disability Index score when adjusting for the corresponding baseline score was -0.28 (95% confidence interval (CI): -4.02, 3.45) which was neither statistically nor clinically significant. No significant differences were found in the secondary outcomes. CONCLUSION: An integrated rehabilitation programme was no more effective than an existing rehabilitation programme at the 26-week follow-up.

The Effect of Patient Characteristics on Acupuncture Treatment Outcomes: An Individual Patient Data Meta-Analysis of 20,827 Chronic Pain Patients in Randomized Controlled Trials.

OBJECTIVES: To optimally select chronic pain patients for different treatments, as it is of interest to identify patient characteristics that might moderate treatment effect. Our aim was to evaluate the impact of possible moderators on the effect of acupuncture treatment using a large data set. METHODS: We used data from an individual patient data meta-analysis of high-quality randomized trials of acupuncture for chronic headache and migraine, osteoarthritis, and back, neck, and shoulder pain. Using meta-analytic trial-level and patient-level regression analyses, we explored the impact of 5 documented patient characteristics (patients' age at baseline, sex, pain duration, baseline pain severity and baseline psychological distress) on the effect of acupuncture. RESULTS: A total of 39 trials met the inclusion criteria: 25 use sham-acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). Of the 5 patient characteristics analyzed, only baseline pain severity was found to potentially moderate the treatment effect of acupuncture, with patients reporting more severe pain at baseline experiencing more benefit from acupuncture compared to either sham-control or non-acupuncture control. Baseline psychological distress showed small treatment moderating effects, and results for sex were inconsistent. There was no strong evidence that age or duration of pain influenced the response to acupuncture. DISCUSSION: Of 5 patient characteristics tested, we found only baseline severity of pain to potentially moderate the effect of acupuncture treatment. For clinical practice, the evidence from this analysis does not justify stratifying chronic pain patients into subgroups that should or should not receive acupuncture on the basis of these 5 characteristics. Future acupuncture trials should assess other potentially important effect moderators.

Prevention and treatment of low back pain: evidence, challenges, and promising directions.

Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences. The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation. These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.

Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis.

Despite wide use in clinical practice, acupuncture remains a controversial treatment for chronic pain. Our objective was to update an individual patient data meta-analysis to determine the effect size of acupuncture for 4 chronic pain conditions. We searched MEDLINE and the Cochrane Central Registry of Controlled Trials randomized trials published up until December 31, 2015. We included randomized trials of acupuncture needling versus either sham acupuncture or no acupuncture control for nonspecific musculoskeletal pain, osteoarthritis, chronic headache, or shoulder pain. Trials were only included if allocation concealment was unambiguously determined to be adequate. Raw data were obtained from study authors and entered into an individual patient data meta-analysis. The main outcome measures were pain and function. An additional 13 trials were identified, with data received for a total of 20,827 patients from 39 trials. Acupuncture was superior to sham as well as no acupuncture control for each pain condition (all P < .001) with differences between groups close to .5 SDs compared with no acupuncture control and close to .2 SDs compared with sham. We also found clear evidence that the effects of acupuncture persist over time with only a small decrease, approximately 15%, in treatment effect at 1 year. In secondary analyses, we found no obvious association between trial outcome and characteristics of acupuncture treatment, but effect sizes of acupuncture were associated with the type of control group, with smaller effects sizes for sham controlled trials that used a penetrating needle for sham, and for trials that had high intensity of intervention in the control arm. We conclude that acupuncture is effective for the treatment of chronic pain, with treatment effects persisting over time. Although factors in addition to the specific effects of needling at correct acupuncture point locations are important contributors to the treatment effect, decreases in pain after acupuncture cannot be explained solely in terms of placebo effects. Variations in the effect size of acupuncture in different trials are driven predominantly by differences in treatments received by the control group rather than by differences in the characteristics of acupuncture treatment. PERSPECTIVE: Acupuncture is effective for the treatment of chronic musculoskeletal, headache, and osteoarthritis pain. Treatment effects of acupuncture persist over time and cannot be explained solely in terms of placebo effects. Referral for a course of acupuncture treatment is a reasonable option for a patient with chronic pain.

Western medical acupuncture in a group setting for knee osteoarthritis: results of a pilot randomised controlled trial.

BACKGROUND: Evidence suggests acupuncture may be effective for treating the symptoms of knee osteoarthritis. Offering this in a group setting may offer cost savings. The aim of this study was to establish the feasibility of a definitive trial to assess the clinical and cost-effectiveness of Western medical acupuncture given in groups, or given individually, for adults with severe knee pain attributable to osteoarthritis. METHODS: A pilot randomised controlled trial (RCT) was conducted. Participants were recruited from seven general practices in Plymouth, Devon. Acupuncture was provided, at a dosage that increased up to and including electroacupuncture if no pain relief was reported, by one experienced acupuncturist in a community clinic. Potentially eligible adults aged at least 45 years with knee osteoarthritis were identified from practice registers, screened and randomised to either: (1) standardised advice and exercise booklet alone ('standard'); (2) booklet plus group acupuncture ('group'); and (3) booklet plus individual acupuncture ('individual'). Both acupuncture arms received up to ten treatments over 12 weeks. Recruitment, retention and data completion rates were recorded, and participants completed questionnaires on acceptability. We collected pain, stiffness and function data (using the Western Ontario McMaster Universities Osteoarthritis Index; WOMAC) and general health (EQ-5D) and economic measures at baseline and 14 weeks post-randomisation. RESULTS: We screened 149 people and randomised 60 (40 %), 20 per arm. The overall 14 week follow-up rate was 77 %, but only 70 % in the 'standard' group; 4.1 % of data points were missing. The study was acceptable to participants. Changes in WOMAC pain score (intention to treat complete case analysis) from baseline to 14 week follow-up were: 'standard', 0.4 (95 % confidence interval (CI) -1.4, 2.2, n = 14); 'group' -3.2 (95 % CI -5.1, -1.4, n = 17); 'individual' -2.4 (95 % CI -4.1, -0.7, n = 15). CONCLUSIONS: A definitive three-arm trial is feasible. Further follow-up reminders, minimum data collection and incentives should be considered to improve participant retention in the follow-up processes in the standardised advice and exercise booklet arm. TRIAL REGISTRATION: ISRCTN05305406.

Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124).

BACKGROUND: Low back pain (LBP) and pelvic girdle pain (PGP) during pregnancy are common and often accepted as a 'normal' part of pregnancy. Many women receive little in the way of treatment, and yet pain interferes with sleep, daily activities and work and leads to increasing requests for induction of labour or elective caesarean section. The aim of this study was to assess the feasibility of a full RCT evaluating the benefit of acupuncture for pregnancy-related back pain. METHODS: This study is a single-centre, three-arm pilot RCT in one large maternity unit and associated antenatal and physiotherapy clinics. Women were eligible if they had pregnancy-related LBP with or without PGP. Exclusions included a history of miscarriage, high risk of early labour or pre-eclampsia, PGP only and previous acupuncture. Interventions were standard care (SC): a self-management booklet with physiotherapy if needed. SC+TA: the booklet and physiotherapy comprising true (penetrating) acupuncture, advice and exercise. SC+NPA: the booklet and physiotherapy comprising non-penetrating acupuncture, advice and exercise. Remote telephone randomisation used a 1:1:1 allocation ratio stratified by gestational weeks. Three measures of pain/function were compared to inform the primary outcome measure in a full RCT: the Pelvic Girdle Questionnaire (PGQ), Oswestry Disability Index (ODI) and 11-point 0-10 numerical rating scale for pain. Analysis focused on process evaluation of recruitment, retention, descriptive information on outcomes, adherence to treatment, occurrence of adverse events and impact of physiotherapist training. RESULTS: One hundred twenty-five women were randomised (45% of those eligible) between April and October 2013; 73% (n = 91) provided 8-week follow-up data. Three of six recruitment methods accounted for 82% of total uptake: screening questionnaire at the 20-week scan, community midwives issuing study cards, and self-referral following local awareness initiatives. Physiotherapists' self-confidence on managing pregnancy-related LBP improved post training. The PGQ is suitable as the primary outcome in a full trial. The average number of treatment sessions in both SC+TA and SC+NPA was six (in line with treatment protocols). No serious adverse events attributable to the trial treatments were reported. CONCLUSIONS: A full RCT is feasible and would provide evidence about the effectiveness of acupuncture and inform treatment choices for women with pregnancy-related LBP. TRIAL REGISTRATION: ISRCTN49955124.

Evaluation of a risk-stratification strategy to improve primary care for low back pain: the MATCH cluster randomized trial protocol.

BACKGROUND: Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients' physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting. METHODS: Six large primary care clinics in an integrated healthcare system in Washington State were block-randomized, three to receive an intensive quality improvement intervention for back pain and three to serve as controls for secular trends. The intervention included 6 one-hour training sessions for physicians, 5 days of training for physical therapists, individualized and group coaching of clinicians, and integration of the STarT Back tool into the electronic health record. This prognostic tool uses 9 questions to categorize patients at low, medium or high risk of persistent disabling pain with recommendations about evidence-based treatment options appropriate for each subgroup. Patients at least 18 years of age, receiving primary care for non-specific low back pain, were invited to provide data 1-3 weeks after their primary care visit and follow-up data 2 months and 6 months (primary endpoint) later. The primary outcomes are back-related physical function and pain severity. Using an intention to treat approach, intervention effects on patient outcomes will be estimated by comparing mean changes at the 2 and 6 month follow-up between the pre- and post-implementation periods. The inclusion of control clinics permits adjustment for secular trends. Differences in change scores by intervention group and time period will be estimated using linear mixed models with random effects. Secondary outcomes include healthcare utilization and adherence to clinical guidelines. DISCUSSION: This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system. TRIAL REGISTRATION: NCT02286141. Registered November 5, 2014.

Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial.

BACKGROUND: Many pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness. OBJECTIVES: To assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain. DESIGN: Phase 1: a questionnaire survey described current care for pregnancy-related back pain. Focus groups and interviews with midwives, physiotherapists and pregnant women explored acceptability and feasibility of acupuncture and the proposed RCT. Phase 2: a single-centre pilot RCT. Participants were identified using six methods and randomised to SC, SC plus true acupuncture or SC plus non-penetrating acupuncture. PARTICIPANTS: Phase 1: 1093 physiotherapists were surveyed and 15 midwives, 21 physiotherapists and 17 pregnant women participated in five focus groups and 20 individual interviews. Phase 2: 125 women with pregnancy-related back pain participated. INTERVENTIONS: SC: a self-management booklet and onward referral for one-to-one physiotherapy (two to four sessions) for those who needed it. SC plus true acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising true (penetrating) acupuncture, advice and exercise. SC plus non-penetrating acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising non-penetrating acupuncture, advice and exercise. MAIN OUTCOME MEASURES: Pilot RCT outcomes included recruitment rates, treatment fidelity, follow-up rate, patient-reported pain and function, quality of life and health-care resource use. Birth and neonatal outcomes were also assessed. Staff overseeing outcome data collection were blind to treatment allocation. RESULTS: Phase 1: 629 (57.5%) physiotherapists responded to the survey, 499 were experienced in treating pregnancy-related back pain and reported 16 advice and 18 treatment options. Typical treatment comprised two to four individual sessions of advice and exercise over 6 weeks. Acupuncture was reported by 24%. Interviews highlighted the impact of back pain and paucity of effective interventions. Women and midwives strongly supported a RCT and expressed few concerns. Physiotherapists' concerns about acupuncture in pregnancy informed a training programme prior to the pilot RCT. Phase 2: We recruited 125 of 280 potentially eligible women (45%) in 6 months and randomised 41 to SC and 42 each to the SC plus true acupuncture and SC plus non-penetrating acupuncture arms. Analysis was conducted with 124 participants (41, 42 and 41, respectively) as one participant was randomised in error. Three of six recruitment methods were the most successful. In total, 10% of women (n = 4) randomised to SC alone accessed one-to-one physiotherapy and received an average of two treatments. The average number of treatments was six for both SC plus true acupuncture and SC plus non-penetrating acupuncture. Treatments were in line with protocols. Eight-week follow-up was 74%. Patient-reported outcomes (pain, function and quality of life) favoured the addition of acupuncture. There was no evidence of serious adverse events on mothers or birth and neonatal outcomes. The Pelvic Girdle Questionnaire was found to be an appropriate outcome measure for a future trial. CONCLUSIONS: A future main RCT is feasible and would be welcomed by women and clinicians. Longer-term follow-up and further follow-up efforts are recommended for a main trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49955124. FUNDING: This project was funded by the National Institute of Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 33. See the NIHR Journals Library website for further project information.

"Lovely Pie in the Sky Plans": A Qualitative Study of Clinicians' Perspectives on Guidelines for Managing Low Back Pain in Primary Care in England.

STUDY DESIGN: A qualitative study in south-west England primary care. OBJECTIVE: To clarify the decision-making processes that result in the delivery of particular treatments to patients with low back pain (LBP) in primary care and to examine clinicians' perspectives on the English National Institute for Health and Care Excellence (NICE) clinical guidelines for managing LBP in primary care. SUMMARY OF BACKGROUND DATA: Merely publishing clinical guidelines is known to be insufficient to ensure their implementation. Gaining an in-depth understanding of clinicians' perspectives on specific clinical guidelines can suggest ways to improve the relevance of guidelines for clinical practice. METHODS: We conducted semi-structured interviews with 53 purposively sampled clinicians. Participants were 16 general practitioners (GPs), 10 chiropractors, 8 acupuncturists, 8 physiotherapists, 7 osteopaths, and 4 nurses, from the public sector (20), private sector (21), or both (12). We used thematic analysis. RESULTS: Official guidelines comprised just 1 of many inputs to clinical decision-making. Clinicians drew on personal experience and inter-professional networks and were constrained by organizational factors when deciding which treatment to prescribe, refer for, or deliver to an individual patient with LBP. Some found the guideline terminology-"non-specific LBP"-unfamiliar and of limited relevance to practice. They were frustrated by disparities between recommendations in the guidelines and the real-world situation of short consultation times, difficult-to-access specialist services, and sparse commissioning of guideline-recommended treatments. CONCLUSION: The NICE guidelines for managing LBP in primary care are one, relatively peripheral, influence on clinical decision-making among GPs, chiropractors, acupuncturists, physiotherapists, osteopaths, and nurses. When revised, these guidelines could be made more clinically relevant by: ensuring that guideline terminology reflects clinical practice terminology; dispelling the image of guidelines as rigid and prohibiting patient-centered care; providing opportunities for clinicians to engage in experiential learning about guideline-recommended complementary therapies; and commissioning guideline-recommended treatments for public sector patients. LEVEL OF EVIDENCE: N/A.

Physical Therapists' Views and Experiences of Pregnancy-Related Low Back Pain and the Role of Acupuncture: Qualitative Exploration.

BACKGROUND: Low back pain is often accepted as a "normal" part of pregnancy. Despite research suggesting that quality of life for women who are pregnant is adversely affected, most are advised to self-manage. Although the use of acupuncture for the management of persistent nonspecific low back pain has been recommended in recent UK national guidelines, its use in the management of pregnancy-related low back pain remains limited. OBJECTIVES: This study aimed to explore the perceptions and experiences of physical therapists involved in treating women who are pregnant and have low back pain with the objective of informing the pretrial training program for a pilot randomized trial (Evaluating Acupuncture and Standard care for pregnant womEn with Back pain [EASE Back]). DESIGN: A qualitative phenomenological method with purposive sampling was used in the study. METHODS: Three focus groups and 3 individual semistructured interviews were undertaken, and an iterative exploratory thematic analysis was performed. To ensure transparency of the research process and the decisions made, an audit trail was created. RESULTS: Twenty-one physical therapists participated, and emergent issues included: a lack of experience in treating pregnancy-related complaints, mixed messages from previous acupuncture education, a mistrust of the current evidence for acupuncture safety and effectiveness, and personal and professional fear of causing harm. CONCLUSIONS: The findings suggest that UK physical therapists are reluctant to use acupuncture in the management of pregnancy-related low back pain. The explanations for these findings include perceived lack of knowledge and confidence, as well as a pervasive professional culture of caution, particularly fears of inducing early labor and of litigation. These findings have been key to informing the content of the training program for physical therapists delivering acupuncture within the pilot EASE Back trial.

Patients' treatment beliefs in low back pain: development and validation of a questionnaire in primary care.

Choosing the most appropriate treatment for individual patients with low back pain (LBP) can be challenging, and clinical guidelines recommend taking into account patients' preferences. However, no tools exist to assess or compare patients' views about LBP treatments. We report the development and validation of the Low Back Pain Treatment Beliefs Questionnaire (LBP-TBQ) for use across different treatments in clinical practice and research. Using qualitative data, we developed a pool of items assessing perceived credibility, effectiveness, concerns about, and individual "fit" of specific treatments. These items were included in a survey completed by 429 primary care patients with LBP, of whom 115 completed it again 1 to 2 weeks later. We performed psychometric analyses using nonparametric item response theory and classical test theory. The 4 subscales of the resulting 16-item LBP-TBQ showed good homogeneity (H = 0.46-0.76), internal consistency (α = 0.73-0.94), and stability (r = 0.63-0.83), confirmed most convergent and discriminant validity hypotheses, and had acceptable structural validity for 4 guideline-recommended treatments: pain medication, exercise, manual therapy, and acupuncture. Participants with stronger positive treatment beliefs were more likely to rank that treatment as their first choice, indicating good criterion validity (t values = 3.11-9.80, all P < 0.01, except pain medication effectiveness beliefs, t(339) = 1.35; P = 0.18). A short 4-item version also displayed good homogeneity (H = 0.43-0.66), internal consistency (α = 0.70-0.86), and stability (r = 0.82-0.85) and was significantly related to treatment choice (t values = 4.33-9.25, all P < 0.01). The LBP-TBQ can be used to assess treatment beliefs in primary care patients with LBP and to investigate the effects of treatment beliefs on treatment uptake and adherence.

Implementing stratified primary care management for low back pain: cost-utility analysis alongside a prospective, population-based, sequential comparison study.

STUDY DESIGN: Within-study cost-utility analysis. OBJECTIVE: To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within risk-defined patient subgroups (that is, patients at low, medium, and high risk of persistent disabling pain). SUMMARY OF BACKGROUND DATA: Individual-level data collected alongside a prospective, sequential comparison of separate patient cohorts with 6-month follow-up. METHODS: Adopting a cost-utility framework, the base case analysis estimated the incremental LBP-related health care cost per additional quality-adjusted life year (QALY) by risk subgroup. QALYs were constructed from responses to the 3-level EQ-5D, a preference-based health-related quality of life instrument. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses examined alternative methodological approaches, including a complete case analysis, the incorporation of non-back pain-related health care use and estimation of societal costs relating to work absence. RESULTS: Stratified care was a dominant treatment strategy compared with usual care for patients at high risk, with mean health care cost savings of £124 and an incremental QALY estimate of 0.023. The likelihood that stratified care provides a cost-effective use of resources for patients at low and medium risk is no greater than 60% irrespective of a decision makers' willingness-to-pay for additional QALYs. Patients at medium and high risk of persistent disability in paid employment at 6-month follow-up reported, on average, 6 fewer days of LBP-related work absence in the stratified care cohort compared with usual care (associated societal cost savings per employed patient of £736 and £652, respectively). CONCLUSION: At the observed level of adherence to screening tool recommendations for matched treatments, stratified care for LBP is cost-effective for patients at high risk of persistent disabling LBP only. LEVEL OF EVIDENCE: 2.

Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials.

BACKGROUND: Recent evidence shows that acupuncture is effective for chronic pain. However we do not know whether there are characteristics of acupuncture or acupuncturists that are associated with better or worse outcomes. METHODS: An existing dataset, developed by the Acupuncture Trialists' Collaboration, included 29 trials of acupuncture for chronic pain with individual data involving 17,922 patients. The available data on characteristics of acupuncture included style of acupuncture, point prescription, location of needles, use of electrical stimulation and moxibustion, number, frequency and duration of sessions, number of needles used and acupuncturist experience. We used random-effects meta-regression to test the effect of each characteristic on the main effect estimate of pain. Where sufficient patient-level data were available, we conducted patient-level analyses. RESULTS: When comparing acupuncture to sham controls, there was little evidence that the effects of acupuncture on pain were modified by any of the acupuncture characteristics evaluated, including style of acupuncture, the number or placement of needles, the number, frequency or duration of sessions, patient-practitioner interactions and the experience of the acupuncturist. When comparing acupuncture to non-acupuncture controls, there was little evidence that these characteristics modified the effect of acupuncture, except better pain outcomes were observed when more needles were used (p=0.010) and, from patient level analysis involving a sub-set of five trials, when a higher number of acupuncture treatment sessions were provided (p<0.001). CONCLUSION: There was little evidence that different characteristics of acupuncture or acupuncturists modified the effect of treatment on pain outcomes. Increased number of needles and more sessions appear to be associated with better outcomes when comparing acupuncture to non-acupuncture controls, suggesting that dose is important. Potential confounders include differences in control group and sample size between trials. Trials to evaluate potentially small differences in outcome associated with different acupuncture characteristics are likely to require large sample sizes.

Missing data and imputation: a practical illustration in a prognostic study on low back pain.

OBJECTIVE: When designing prediction models by complete case analysis (CCA), missing information in either baseline (predictors) or outcomes may lead to biased results. Multiple imputation (MI) has been shown to be suitable for obtaining unbiased results. This study provides researchers with an empirical illustration of the use of MI in a data set on low back pain, by comparing MI with the more commonly used CCA. Effects will be shown of imputing missing information on the composition and performance of prognostic models, distinguishing imputation of missing values in baseline characteristics and outcome data. METHODS: Data came from the Beliefs about Backpain cohort, a study of psychologic obstacles to recovery in primary care back pain patients in the United Kingdom. Candidate predictors included demographics, back pain characteristics, and psychologic variables. Complete case analysis was compared with MI within patients with complete outcome but missing baseline data (n=809) and patients with missing baseline or outcome data (n=1591). Multiple imputation was performed by a Multiple Imputation by Chained Equations procedure. RESULTS: Cases with missing outcome data (n=782, 49.1%) or with missing baseline data (n=116, 8%) both differed from complete cases regarding the distribution of some predictors and more often had a poor outcome. When comparing CCA with MI, model composition showed to be affected. CONCLUSIONS: Complete case analysis can give biased results, even when only small amounts of data are missing. Now that MI is available in standard statistical software, we recommend that it be used to handle missing data.

Acupuncture for chronic pain: individual patient data meta-analysis.

BACKGROUND: Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain. METHODS: We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed. RESULTS: In the primary analysis, including all eligible RCTs, acupuncture was superior to both sham and no-acupuncture control for each pain condition (P < .001 for all comparisons). After exclusion of an outlying set of RCTs that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs. These results were robust to a variety of sensitivity analyses, including those related to publication bias. CONCLUSIONS: Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

Taking responsibility for the early assessment and treatment of patients with musculoskeletal pain: a review and critical analysis.

Musculoskeletal pain is common across all populations and costly in terms of impact on the individual and, more generally, on society. In most health-care systems, the first person to see the patient with a musculoskeletal problem such as back pain is the general practitioner, and access to other professionals such as physiotherapists, chiropractors, or osteopaths is still either largely controlled by a traditional medical model of referral or left to self-referral by the patient. In this paper, we examine the arguments for the general practitioner-led model and consider the arguments, and underpinning evidence, for reconsidering who should take responsibility for the early assessment and treatment of patients with musculoskeletal problems.

Cost-effectiveness of acupuncture care as an adjunct to exercise-based physical therapy for osteoarthritis of the knee.

BACKGROUND: The delivery of acupuncture alongside mainstream interventions and the cost-effectiveness of "alternative" treatments remain areas of controversy. OBJECTIVE: The aim of this study was to assess the cost-utility of adding acupuncture to a course of advice and exercise delivered by UK National Health Service (NHS) physical therapists to people with osteoarthritis of the knee. DESIGN: A cost-utility analysis was performed alongside a randomized controlled trial. METHODS: A total of 352 adults (aged 50 years or older) were randomly assigned to receive 1 of 3 interventions. The primary analysis focused on participants receiving advice and exercise (AE) or advice and exercise plus true acupuncture (AE+TA). A secondary analysis considered participants receiving advice and exercise plus nonpenetrating acupuncture (AE+NPA). The main outcome measures were quality-adjusted life years (QALYs), measured by the EQ-5D, and UK NHS costs. RESULTS: were expressed as the incremental cost per QALY gained over 12 months. Sensitivity analyses included a broader cost perspective to incorporate private out-of-pocket costs. Results NHS costs were higher for AE+TA (£314 [British pounds sterling]) than for AE alone (£229), and the difference in mean QALYs favored AE+TA (mean difference=0.022). The base-case cost per QALY gained was £3,889; this value was associated with a 77% probability that AE+TA would be more cost-effective than AE at a threshold of £20,000 per QALY. Cost-utility data for AE+NPA provided cost-effectiveness estimates similar to those for AE+TA. LIMITATIONS: As with all trial-based economic evaluations, caution should be exercised when generalizing results beyond the study perspectives. CONCLUSIONS: A package of AE+TA delivered by NHS physical therapists provided a cost-effective use of health care resources despite an associated increase in costs. However, the economic benefits could not be attributed to the penetrating nature of conventional acupuncture; therefore, further research regarding the mechanisms of acupuncture is needed. An analysis of alternative cost perspectives suggested that the results are generalizable to other health care settings.