RESUMEN
BACKGROUND: Low back pain is common and a significant number of patients experience chronic low back pain. Current treatment options offer small to moderate effects. Patients with vertebral bone marrow lesions visualized as Modic changes on magnetic resonance imaging may represent a subgroup within the low back pain population. There is evidence for inflammatory mediators being involved in development of Modic changes; hence, suppression of inflammation could be a treatment strategy for these patients. This study examines the effect of anti-inflammatory treatment with the TNF-α inhibitor infliximab in patients with chronic low back pain and Modic changes. METHODS/DESIGN: The BackToBasic trial is a multicenter, double blind, randomized controlled trial conducted at six hospitals in Norway, comparing intravenous infusions with infliximab with placebo. One hundred twenty-six patients aged 18-65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients' clinics. The primary outcome is back pain-specific disability at day 154 (5 months). The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months. The study also aims to refine MRI-assessment, investigate safety and cost-effectiveness and explore the underlying biological mechanisms of Modic changes. DISCUSSION: Finding treatments that target underlying mechanisms could pose new treatment options for patients with low back pain. Suppression of inflammation could be a treatment strategy for patients with low back pain and Modic changes. This paper presents the design of the BackToBasic study, where we will assess the effect of an anti-inflammatory treatment versus placebo in patients with chronic low back pain and type 1 Modic changes. The study is registered at ClinicalTrials.gov under the identifier NCT03704363 . The EudraCT Number: 2017-004861-29.
Asunto(s)
Dolor Crónico , Dolor de la Región Lumbar , Adolescente , Adulto , Anciano , Dolor Crónico/diagnóstico por imagen , Dolor Crónico/tratamiento farmacológico , Humanos , Infliximab/efectos adversos , Dolor de la Región Lumbar/diagnóstico por imagen , Dolor de la Región Lumbar/tratamiento farmacológico , Vértebras Lumbares , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Noruega , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Adulto JovenRESUMEN
ABSTRACT: This trial assessed the efficacy of naproxen in patients with sciatica in outpatient clinics across 4 Norwegian hospitals. A total of 123 adults with radiating pain below the knee (≥4 on a 0-10 numeric rating scale) and signs consistent with nerve root involvement were included. Participants were randomized to receive either naproxen 500 mg or a placebo twice daily for 10 days. The primary outcome, daily leg pain intensity measured on a 0 to 10 numeric rating scale throughout the treatment period, revealed a statistically significant difference in favor of naproxen, with an adjusted mean difference of -0.5 (95% CI -0.8 to -0.1, P = 0.015). In the naproxen group, the treatment effect was significantly related to time, and over the whole 10-day period, the average adjusted difference was -0.6 (95% CI -0.8 to -0.5). Mean numbers needed to treat for 30% and 50% improvement were 9.9 (95% CI 4.7-15.0) and 20.7 (8.7-32.7), respectively. The adjusted mean difference for back pain was -0.4 (95% CI -0.8 to 0.0), and for Roland Morris Disability Questionnaire for Sciatica, it was -1.5 (95% CI -3.0 to 0.0). No differences were found for sciatica bothersomeness or consumption of rescue medication or opioids. Participants in the naproxen group exhibited an adjusted odds ratio of 4.7 (95% CI 1.3-16.2) for improvement by 1 level on the global perceived change scale. In conclusion, naproxen treatment showed small, likely clinically unimportant benefits compared with placebo in patients with moderate-to-severe sciatica.
RESUMEN
BACKGROUND: Persistent pain is a frequent cause of sick leave and work disability in Norway. A return-to-work intervention featuring supported work placements, developed in the UK, demonstrated feasibility, and a return-to-work rate of 20% within 6 months was observed in the sample. We sought to adapt the intervention for delivery in Norway and to confirm feasibility prior to a full-scale trial. METHODS: In this internal pilot, we used a pragmatic cohort randomised controlled approach with national recruitment in Norway. We recruited people who were unemployed (for at least 1 month), having persistent pain (for at least 3 months), aged between 18 and 64, and wanting to return to work. We initially recruited people to an observational cohort study of the impact of being unemployed with persistent pain. After baseline measurement, we randomly sub-sampled participants to whom we offered the intervention, which featured individual case management and support, work-familiarisation sessions, and the offer of a 6-week part-time unpaid work placement. We assessed recruitment rates (aiming to recruit 66, and sub-sample 17 within 6 months); optimal recruitment pathways; intervention acceptance rates; the feasibility of data collection; using video links for work-familiarisation sessions and remote case manager support. RESULTS: The pilot ran from June to November 2022. Of 168 people expressing interest, 94 consented. Recruitment posts on Facebook yielded the most 'expressions of interest' (66%, n = 111). After screening for eligibility, we included 55 participants. Of these, 19 were randomised to be offered the intervention. Of these, less than half (n = 8) consented to intervention participation. Remote case manager and work-familiarisation sessions appeared feasible. Following a delay in identifying placements, three participants received offers of work placements, with one starting and completing during the pilot period. Data collection methods were feasible, and no adverse events were reported. CONCLUSIONS: Recruitment and logistical processes, such as remote management by video link, are feasible. However, delivery of the intervention is challenging. In particular, sourcing placements and the time required for identifying appropriate placements was more challenging than anticipated. A full-scale trial is feasible but will require improvements to the placement identification processes. TRIAL REGISTRATION: ISRCTN85437524 (Referring to the ReISE trial, of which this internal pilot was a part), Registered 31 of May 2022 https://doi.org/10.1186/ISRCTN85437524 TRIAL FUNDING: Norwegian Research Council.
RESUMEN
BACKGROUND: Around one-third of workdays lost in Norway are due to musculoskeletal conditions, with persistent (chronic) pain being the most frequent cause of sick leave and work disability. Increasing work participation for people with persistent pain improves their health, quality of life, and well-being and reduces poverty; however, it is not clear how to best help unemployed people who have persistent pain to return to work. The aim of this study is to examine if a matched work placement intervention featuring case manager support and work-focused healthcare improves return to work rates and quality of life for unemployed people in Norway with persistent pain who want to work. METHODS: We will use a cohort randomised controlled approach to test the effectiveness and cost-effectiveness of a matched work placement intervention featuring case manager support and work-focused healthcare compared to those receiving usual care in the cohort alone. We will recruit people aged 18-64, who have been out of work for at least 1 month, had pain for more than 3 months, and want to work. Initially, all (n = 228) will be recruited to an observational cohort study on the impact of being unemployed with persistent pain. We will then randomly select one in three to be offered the intervention. The primary outcome of sustained return to work will be measured using registry and self-reported data, while secondary outcomes include self-reported levels of health-related quality of life and physical and mental health. Outcomes will be measured at baseline and 3, 6, and 12 months post-randomisation. We will run a process evaluation parallel to the intervention exploring implementation, continuity of the intervention, reasons for participating, declining participation, and mechanisms behind cases of sustained return to work. An economic evaluation of the trial process will also be conducted. DISCUSSION: The ReISE intervention is designed to increase work participation for people with persistent pain. The intervention has the potential to improve work ability by collaboratively navigating obstacles to working. If successful, the intervention may be a viable option for helping people in this population. TRIAL REGISTRATION: ISRCTN Registry 85,437,524 Registered on 30 March 2022.
Asunto(s)
Dolor Crónico , Calidad de Vida , Humanos , Reinserción al Trabajo , Rehabilitación Vocacional/métodos , Desempleo , Análisis Costo-Beneficio , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Observacionales como AsuntoRESUMEN
OBJECTIVE: To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). DESIGN: Double blind, parallel group, placebo controlled, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. PARTICIPANTS: 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. INTERVENTIONS: Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. MAIN OUTCOME MEASURES: The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. RESULTS: In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was -1.6 (95% confidence interval -3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was -2.3 (-4.2 to-0.4, P=0.02) for patients with type 1 Modic changes and -0.1 (-2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. CONCLUSIONS: In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323412.