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BACKGROUND: Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain. METHODS: WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112). FINDINGS: Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60-0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149-295) in the intervention group and 112 days (89-140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group). INTERPRETATION: An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed. FUNDING: National Health and Medical Research Council, Australia.
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Análisis Costo-Beneficio , Dolor de la Región Lumbar , Prevención Secundaria , Caminata , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Australia , Terapia por Ejercicio/economía , Terapia por Ejercicio/métodos , Dolor de la Región Lumbar/prevención & control , Dolor de la Región Lumbar/economía , Educación del Paciente como Asunto/métodos , Educación del Paciente como Asunto/economía , Años de Vida Ajustados por Calidad de Vida , Prevención Secundaria/economía , Prevención Secundaria/métodos , Resultado del Tratamiento , AncianoRESUMEN
BACKGROUND: Multimodal analgesia regimens are recommended for the postoperative period after hip and knee replacement surgeries. However, there are no data on practice patterns for analgesic use in the immediate postoperative period after hip and knee replacements in Australia. OBJECTIVES: To describe analgesic prescribing patterns in the inpatient postoperative phase for patients undergoing hip and knee replacement. METHODS: Retrospective study of electronic medical record data from two major hospitals in Sydney, Australia. We identified analgesic medication prescriptions for all patients aged 18 years and older who underwent hip or knee replacement surgery in 2019. We extracted data on pain medications prescribed while in the ward up until discharge. These were grouped into distinct categories based on the Anatomical Therapeutic Chemical classification. We described the frequency (%) of pain medications used by category and computed the average oral morphine equivalent daily dose (OMEDD) during hospitalisation. RESULTS: We identified 1282 surgeries in 1225 patients. Patients had a mean (SD) age of 69 (11.8) years; most (57.1%) were female. Over 99% of patients were prescribed opioid analgesics and paracetamol during their hospital stay. Most patients (61.4%) were managed with paracetamol and opioids only. The most common prescribed opioid was oxycodone (87.3% of patients). Only 19% of patients were prescribed nonsteroidal anti-inflammatories (NSAIDs). The median (IQR) average daily OMEDD was 50.2 mg (30.3-77.9). CONCLUSION: We identified high use of opioids analgesics as the main strategies for pain control after hip and knee replacement in hospital. Other analgesics were much less frequently used, such as NSAIDs, and always in combination with opioids and paracetamol.
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Analgésicos Opioides , Dolor de Cuello , Humanos , Dolor de Cuello/tratamiento farmacológico , Dolor de Cuello/etiología , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/administración & dosificación , Dolor de Espalda/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND AND OBJECTIVE: Although paracetamol (acetaminophen) combined with other analgesics can reduce pain intensity in some pain conditions, its effectiveness in managing low back pain and osteoarthritis is unclear. This systematic review investigated whether paracetamol combination therapy is more effective and safer than monotherapy or placebo in low back pain and osteoarthritis. METHODS: Online database searches were conducted for randomised trials that evaluated paracetamol combined with another analgesic compared to a placebo or the non-paracetamol ingredient in the combination (monotherapy) in low back pain and osteoarthritis. The primary outcome was a change in pain. Secondary outcomes were (serious) adverse events, changes in disability and quality of life. Follow-up was immediate (≤ 2 weeks), short (> 2 weeks but ≤ 3 months), intermediate (> 3 months but < 12 months) or long term (≥ 12 months). A random-effects meta-analysis was conducted. Risk of bias was assessed using the original Cochrane tool, and quality of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Twenty-two studies were included. Pain was reduced with oral paracetamol plus a non-steroidal anti-inflammatory drug (NSAID) at immediate term in low back pain (paracetamol plus ibuprofen vs ibuprofen [mean difference (MD) - 6.2, 95% confidence interval (CI) -10.4 to -2.0, moderate evidence]) and in osteoarthritis (paracetamol plus aceclofenac vs aceclofenac [MD - 4.7, 95% CI - 8.3 to - 1.2, moderate certainty evidence] and paracetamol plus etodolac vs etodolac [MD - 15.1, 95% CI - 18.5 to - 11.8; moderate certainty evidence]). Paracetamol plus oral tramadol reduced pain compared with placebo at intermediate term for low back pain (MD - 11.7, 95% CI - 19.2 to - 4.3; very low certainty evidence) and osteoarthritis (MD - 6.8, 95% CI - 12.7 to -0.9; moderate certainty evidence). Disability scores improved in half the comparisons. Quality of life was infrequently measured. All paracetamol plus NSAID combinations did not increase the risk of adverse events compared to NSAID monotherapy. CONCLUSIONS: Low-to-moderate quality evidence supports the oral use of some paracetamol plus NSAID combinations for short-term pain relief with no increased risk of harm for low back pain and osteoarthritis compared to its non-paracetamol monotherapy comparator.
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Acetaminofén , Analgésicos no Narcóticos , Antiinflamatorios no Esteroideos , Dolor de la Región Lumbar , Osteoartritis , Humanos , Acetaminofén/administración & dosificación , Acetaminofén/efectos adversos , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/efectos adversos , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/efectos adversos , Quimioterapia Combinada/métodos , Ibuprofeno/administración & dosificación , Ibuprofeno/efectos adversos , Dolor de la Región Lumbar/tratamiento farmacológico , Osteoartritis/tratamiento farmacológico , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Administración OralRESUMEN
OBJECTIVE: To evaluate the efficacy of opioids for people with acute musculoskeletal pain against placebo. STUDY DESIGN: Systematic review and meta-analyses of randomised, placebo-controlled trials of opioid analgesics for acute musculoskeletal pain in any setting. The primary outcomes were pain and disability at the immediate timepoint (< 24 h). DATA SOURCES: Multiple databases were searched from their inception to February 22nd, 2023. DATA SYNTHESIS: Continuous outcomes were converted to a 0-100 scale. Dichotomous outcomes were presented as risk differences. Risk of bias and certainty of evidence was assessed. RESULTS: We located 17 trials (1 intravenous and 16 oral route of administration). For adults, high certainty evidence from 11 comparisons shows that oral opioids provide small benefits relative to placebo in the immediate term for pain (mean difference [MD] - 8.8 95% confidence interval [CI] - 12.0 to - 5.6). For disability, the difference is uncertain (MD - 6.2, 95% CI - 17.8 to 5.4). Opioid groups were at higher risk of adverse events (MD 14.3%, 95% CI 8.3-20.4%, very low certainty). There was moderate certainty evidence of a large effect of IV morphine on sciatica pain (MD -42.5, 95% CI - 49.9 to - 35.1, n = 197, 1 study). In paediatric populations, moderate certainty evidence from 3 trials shows that oral opioids probably do not provide benefit beyond that of placebo for pain (MD 6.1, 95% CI - 1.7 to 12.8) and there was no evidence for disability. There was low certainty evidence that there may be no difference in adverse events (MD 10.4%, 95% CI - 0.6 to 21.4%). DISCUSSION: Intravenous morphine likely offers benefits, but oral opioids may not provide clinically meaningful benefits. PROSPERO REGISTRATION: CRD42021249346.
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Dolor Agudo , Analgésicos Opioides , Dolor Musculoesquelético , Humanos , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/administración & dosificación , Dolor Musculoesquelético/tratamiento farmacológico , Dolor Agudo/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Administración OralRESUMEN
Preventing avoidable venous-thrombo-embolism (VTE) is a priority to improve patient and service outcomes after total hip and total knee arthroplasty (THA, TKA), but compliance with relevant clinical guidelines varies. This study aims to determine the degree to which prophylaxis was compliant with Australian Orthopaedic Association (AOA) VTE prophylaxis guidelines and whether non-compliance is associated with increased risk of VTE. A prospective multi-centre cohort study of adults with osteoarthritis undergoing primary TKA/THA was completed at 19 high-volume public and private hospitals. Data were collected prior to surgery and for one-year post-surgery. Logistic regression was undertaken to explore associations between non-compliance with AOA VTE prophylaxis guidelines and symptomatic 90-day VTE outcomes. Data were analysed for 1838 participants from 19 sites. The rate of non-compliance with all clinical guideline recommendations was 20.1% (N = 369), with 14.1% (N = 259) non-compliance for risk-stratified prophylaxis, 35.8% (N = 658) for duration, and 67.8% (N = 1246) for other general recommendations. Symptomatic VTE was experienced up to 90-days post-surgery by 48 people (2.6%). Overall guideline non-compliance (AOR = 0.93, 95%CI = 0.4 to 1.3, p = 0.86) was not associated with a lower risk of symptomatic 90-day VTE. Results were consistent when people with high bleeding risk were excluded (AOR = 0.94, 95%CI = 0.44 to 2.34, p = 0.89). Non-compliance with the AOA VTE prophylaxis guidelines was not associated with risk of 90-day VTE after arthroplasty. This counterintuitive finding is concerning and necessitates a rigorous review of the AOA VTE prevention clinical guideline.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Ortopedia , Tromboembolia Venosa , Adulto , Humanos , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/tratamiento farmacológico , Artroplastia de Reemplazo de Rodilla/efectos adversos , Estudios de Cohortes , Estudios Prospectivos , Australia , Artroplastia de Reemplazo de Cadera/efectos adversos , Anticoagulantes/uso terapéutico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/tratamiento farmacológicoRESUMEN
OBJECTIVES: To describe the development and use of an Evidence to Decision (EtD) framework when formulating recommendations for the Evidence-Based Clinical Practice Guideline for Deprescribing Opioid Analgesics. STUDY DESIGN AND SETTING: Evidence was derived from an overview of systematic reviews and qualitative studies conducted with healthcare professionals and people who take opioids for pain. A multidisciplinary guideline development group conducted extensive EtD framework review and iterative refinement to ensure that guideline recommendations captured contextual factors relevant to the guideline target setting and audience. RESULTS: The guideline development group considered and accounted for the complexities of opioid deprescribing at the individual and health system level, shaping recommendations and practice points to facilitate point-of-care use. Stakeholders exhibited diverse preferences, beliefs, and values. This variability, low certainty of evidence, and system-level policies and funding models impacted the strength of the generated recommendations, resulting in the formulation of four 'conditional' recommendations. CONCLUSION: The context within which evidence-based recommendations are considered, as well as the political and health system environment, can contribute to the success of recommendation implementation. Use of an EtD framework allowed for the development of implementable recommendations relevant at the point-of-care through consideration of limitations of the evidence and relevant contextual factors.
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Deprescripciones , Medicina Basada en la Evidencia , Humanos , Analgésicos Opioides/uso terapéutico , Sistemas de Atención de Punto , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: The prevalence of continued opioid use or serious adverse events (SAEs) following opioid therapy in the emergency department (ED) for musculoskeletal pain is unclear. The aim of this review was to examine the prevalence of continued opioid use and serious adverse events (SAEs) following the provision of opioids for musculoskeletal pain in the emergency department (ED) or at discharge. METHODS: Records were searched from MEDLINE, EMBASE and CINAHL from inception to 7 October 2022. We included randomised controlled trials and observational studies enrolling adult patients with musculoskeletal pain who were administered and/or prescribed opioids in the ED. Continued opioid use and opioid misuse data after day 4 since ED discharge were extracted. Adverse events were coded using the Common Terminology Criteria for Adverse Events (CTCAE), and those rated as grades 3-4 (severe or life-threatening) and grade 5 (death) were considered SAEs. Risk of bias was assessed using the Quality in Prognosis Studies (QUIPS) tool. RESULTS: Seventy-two studies were included. Among opioid-naïve patients who received an opioid prescription, 6.8-7.0% reported recent opioid use at 3-12 months after discharge, 4.4% filled ≥ 5 opioid prescriptions and 3.1% filled > 90-day supply of opioids within 6 months. The prevalence of SAEs was 0.02% [95% confidence interval (CI) 0, 0.2%] in the ED and 0.1% (95% CI 0, 1.5%) within 2 days. One study observed 42.9% of patients misused opioids within 30 days after discharge. CONCLUSIONS: Around 7% of opioid-naïve patients with musculoskeletal pain receiving opioid therapy continue opioid use at 3-12 months after ED discharge. SAEs following ED administration of an opioid were uncommon; however, studies only monitored patients for 2 days. PROTOCOL REGISTRATION: 10.31219/osf.io/w4z3u.
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Dolor Musculoesquelético , Trastornos Relacionados con Opioides , Adulto , Humanos , Analgésicos Opioides/efectos adversos , Dolor Musculoesquelético/tratamiento farmacológico , Dolor Musculoesquelético/inducido químicamente , Trastornos Relacionados con Opioides/tratamiento farmacológico , Servicio de Urgencia en Hospital , Manejo del DolorRESUMEN
BACKGROUND: Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce. We aimed to investigate the efficacy and safety of a judicious short course of an opioid analgesic for acute low back pain and neck pain. METHODS: OPAL was a triple-blinded, placebo-controlled randomised trial that recruited adults (aged ≥18 years) presenting to one of 157 primary care or emergency department sites in Sydney, NSW, Australia, with 12 weeks or less of low back or neck pain (or both) of at least moderate pain severity. Participants were randomly assigned (1:1) using statistician-generated randomly permuted blocks to guideline-recommended care plus an opioid (oxycodone-naloxone, up to 20 mg oxycodone per day orally) or guideline-recommended care and an identical placebo, for up to 6 weeks. The primary outcome was pain severity at 6 weeks measured with the pain severity subscale of the Brief Pain Inventory (10-point scale), analysed in all eligible participants who provided at least one post-randomisation pain score, by use of a repeated measures linear mixed model. Safety was analysed in all randomly assigned eligible participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000775516). FINDINGS: Between Feb 29, 2016, and March 10, 2022, 347 participants were recruited (174 to the opioid group and 173 to the placebo group). 170 (49%) of 346 participants were female and 176 (51%) were male. 33 (19%) of 174 participants in the opioid group and 25 (15%) of 172 in the placebo group had discontinued from the trial by week 6, due to loss to follow-up and participant withdrawals. 151 participants in the opioid group and 159 in the placebo group were included in the primary analysis. Mean pain score at 6 weeks was 2·78 (SE 0·20) in the opioid group versus 2·25 (0·19) in the placebo group (adjusted mean difference 0·53, 95% CI -0·00 to 1·07, p=0·051). 61 (35%) of 174 participants in the opioid group reported at least one adverse event versus 51 (30%) of 172 in the placebo group (p=0·30), but more people in the opioid group reported opioid-related adverse events (eg, 13 [7·5%] of 174 participants in the opioid group reported constipation vs six [3·5%] of 173 in the placebo group). INTERPRETATION: Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions. FUNDING: National Health and Medical Research Council, University of Sydney Faculty of Medicine and Health, and SafeWork SA.
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Dolor Agudo , Analgesia , Dolor de la Región Lumbar , Adulto , Humanos , Masculino , Femenino , Adolescente , Analgésicos Opioides/efectos adversos , Oxicodona/efectos adversos , Dolor de la Región Lumbar/tratamiento farmacológico , Dolor de Cuello/tratamiento farmacológico , Australia , Dolor Agudo/tratamiento farmacológicoRESUMEN
QUESTIONS: What motivates individuals to start a walking program for the prevention of low back pain? What strategies optimise short-term and long-term adherence to a walking program? What strategies can physiotherapists incorporate into clinical practice to facilitate commencement of and adherence to a walking program? DESIGN: Qualitative study. PARTICIPANTS: Twenty-two adults recently recovered from an episode of non-specific low back pain who participated in a 6-month, progressive and individualised walking program that was prescribed by a physiotherapist trained in health coaching. METHODS: Semi-structured focus groups conducted online following completion of the walking program. Interview questions explored: primary motivations for starting a walking program, identification of which elements were useful in optimising adherence to the program, and identification of the barriers to and facilitators of engagement with the program. Audio recordings were transcribed and thematic analysis was conducted. RESULTS: Three major themes were identified. Theme one identified that strong motivators to start a walking program were anticipated improvements in low back pain management and the added general health benefits of a more active lifestyle. Theme two identified that fear of high-impact exercises led to avoidance; however, walking was considered a safe exercise option. Theme three identified accountability, enjoyment of exercise and health benefits were critical to adherence. CONCLUSION: Participants recently recovered from low back pain reflected positively on a physiotherapist-prescribed walking program. Participants described what elements of the program were crucial to starting exercise and optimising adherence. These findings have informed a list of practical recommendations for physiotherapists to improve patient commencement and adherence to exercise.
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Dolor de la Región Lumbar , Tutoría , Fisioterapeutas , Adulto , Humanos , Dolor de la Región Lumbar/terapia , Terapia por Ejercicio/métodos , Investigación Cualitativa , CaminataRESUMEN
ABSTRACT: Pain radiating from the spine into the leg is commonly referred to as "sciatica," "Sciatica" may include various conditions such as radicular pain or painful radiculopathy. It may be associated with significant consequences for the person living with the condition, imposing a reduced quality of life and substantial direct and indirect costs. The main challenges associated with a diagnosis of "sciatica" include those related to the inconsistent use of terminology for the diagnostic labels and the identification of neuropathic pain. These challenges hinder collective clinical and scientific understanding regarding these conditions. In this position paper, we describe the outcome of a working group commissioned by the Neuropathic Pain Special Interest Group (NeuPSIG) of the International Association for the Study of Pain (IASP) which was tasked with the following objectives: (1) to revise the use of terminology for classifying spine-related leg pain and (2) to propose a way forward on the identification of neuropathic pain in the context of spine-related leg pain. The panel recommended discouraging the term "sciatica" for use in clinical practice and research without further specification of what it entails. The term "spine-related leg pain" is proposed as an umbrella term to include the case definitions of somatic referred pain and radicular pain with and without radiculopathy. The panel proposed an adaptation of the neuropathic pain grading system in the context of spine-related leg pain to facilitate the identification of neuropathic pain and initiation of specific management in this patient population.
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Neuralgia , Radiculopatía , Ciática , Humanos , Pierna , Calidad de Vida , Neuralgia/diagnóstico , Neuralgia/complicaciones , Ciática/complicacionesRESUMEN
OBJECTIVE: To investigate the effectiveness and safety of surgery compared with non-surgical treatment for sciatica. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the World Health Organisation International Clinical Trials Registry Platform from database inception to June 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials comparing any surgical treatment with non-surgical treatment, epidural steroid injections, or placebo or sham surgery, in people with sciatica of any duration due to lumbar disc herniation (diagnosed by radiological imaging). DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data. Leg pain and disability were the primary outcomes. Adverse events, back pain, quality of life, and satisfaction with treatment were the secondary outcomes. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst pain or disability). Data were pooled using a random effects model. Risk of bias was assessed with the Cochrane Collaboration's tool and certainty of evidence with the grading of recommendations assessment, development, and evaluation (GRADE) framework. Follow-up times were into immediate term (≤six weeks), short term (>six weeks and ≤three months), medium term (>three and <12 months), and long term (at 12 months). RESULTS: 24 trials were included, half of these investigated the effectiveness of discectomy compared with non-surgical treatment or epidural steroid injections (1711 participants). Very low to low certainty evidence showed that discectomy, compared with non-surgical treatment, reduced leg pain: the effect size was moderate at immediate term (mean difference -12.1 (95% confidence interval -23.6 to -0.5)) and short term (-11.7 (-18.6 to -4.7)), and small at medium term (-6.5 (-11.0 to -2.1)). Negligible effects were noted at long term (-2.3 (-4.5 to -0.2)). For disability, small, negligible, or no effects were found. A similar effect on leg pain was found when comparing discectomy with epidural steroid injections. For disability, a moderate effect was found at short term, but no effect was observed at medium and long term. The risk of any adverse events was similar between discectomy and non-surgical treatment (risk ratio 1.34 (95% confidence interval 0.91 to 1.98)). CONCLUSION: Very low to low certainty evidence suggests that discectomy was superior to non-surgical treatment or epidural steroid injections in reducing leg pain and disability in people with sciatica with a surgical indication, but the benefits declined over time. Discectomy might be an option for people with sciatica who feel that the rapid relief offered by discectomy outweighs the risks and costs associated with surgery. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021269997.
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Desplazamiento del Disco Intervertebral , Ciática , Humanos , Ciática/terapia , Ciática/tratamiento farmacológico , Calidad de Vida , Dolor de Espalda , Desplazamiento del Disco Intervertebral/complicaciones , Desplazamiento del Disco Intervertebral/cirugía , Esteroides/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: There is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment). OBJECTIVES: To evaluate the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and two trials registers up to 15 August 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: This review included five RCTs with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events. McKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention - main comparison) There is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.3, 95% CI -12.0 to -2.56; 2 trials, 377 participants) but not in the intermediate term (MD -5.0, 95% CI -14.3 to 4.3; 1 trial, 180 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.5, 95% CI -7.5 to 2.0; 2 trials, 328 participants) nor in the intermediate term (MD -0.9, 95% CI -7.3 to 5.6; 1 trial, 180 participants). McKenzie method versus manual therapy There is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.7, 95% CI -27.4 to 10.0; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.0, 95% CI 0.7 to 13.3; 1 trial, 235 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -5.0, 95% CI -15.0 to 5.0; 3 trials, 298 participants) nor in the intermediate term (MD 4.3, 95% CI -0.7 to 9.3; 1 trial, 235 participants). McKenzie method versus other interventions (massage and advice) There is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.0, 95% CI -15.4 to 23.4; 1 trial, 30 participants) nor in the intermediate term (MD 10.0, 95% CI -8.9 to 28.9; 1 trial, 30 participants). AUTHORS' CONCLUSIONS: Based on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.
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Dolor Agudo , Dolor de la Región Lumbar , Adulto , Humanos , Dolor de la Región Lumbar/terapia , Dolor Agudo/terapia , Terapia por Ejercicio , Resultado del Tratamiento , Calidad de VidaRESUMEN
BACKGROUND: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial. METHODS: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test. DISCUSSION: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial. TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.