Efficacy of a TNF inhibitor in chronic low back pain with Modic changes type 1: The BackToBasic study A randomized controlled trial.

Objective: The efficacy of TNF inhibitors for treating chronic low back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic changes type 1.

Methods: In this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18-65 with moderate to severe chronic low back pain and Modic changes type 1 were enrolled from five Norwegian public hospitals between January 2019 and October 2022.

Efficacy of naproxen in patients with sciatica: multicenter, randomized, double-blind, placebo-controlled trial.

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 terminologies of transient, migratory, or localized osteoporosis, and bone marrow edema syndrome: a scoping review.

There is no formally defined terminology for the related entities transient osteoporosis of the hip (TOH), localized or regional migratory osteoporosis (RMO) and bone marrow edema syndrome (BMES). This study aimed to map the diversity and frequency of diagnostic terms and vocabulary utilized in the literature. A comprehensive search of electronic databases and reference lists was conducted.

Longitudinal Relationship Between Reduced Modic Change Edema and Disability and Pain in Patients With Chronic Low Back Pain.

Study Design: Secondary analyses of a randomized trial [Antibiotics In Modic changes (MCs) study].

Objective: To assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP).

Summary Of Background Data: It is not clear whether or not reduced MC edema implies improved clinical outcomes.

Symptom descriptors and patterns in lumbar radicular pain caused by disc herniation: a 1-year longitudinal cohort study.

Objective: The objective of the present study was to explore the diversity, quality, severity and distribution of symptoms in patients with radicular pain and a lumbar disc herniation.

Design: Longitudinal cohort study.

Setting: Hospital-based back clinic.

Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain.

Objectives: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes.

Study Design And Setting: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect.

Strategies to manage auxiliary pain medications in chronic pain trials: a topical review.

Chronic pain trials commonly allow auxiliary pain medications such as rescue and concomitant analgesics in addition to the randomized treatment. Changes in auxiliary pain medications after randomization represent intercurrent events that may affect either the interpretation or the existence of the measurements associated with the clinical question of interest, complicating the assessment of treatment efficacy. In chronic pain trials, pain intensity typically varies and patients may take the auxiliary medications 1 day but not the next or increase and decrease the dosages temporarily while continuing their randomized study medication.

NSAIDs in sciatica (NIS): study protocol for an investigator-initiated multicentre, randomized placebo-controlled trial of naproxen in patients with sciatica.

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to treat sciatica, despite insufficient evidence from placebo-controlled trials. NSAIDs may cause serious side effects; hence, there is a strong need to clarify their potential beneficial effects in patients with sciatica.

Methods: This is a multicentre, randomized, placebo-controlled, parallel-group superiority trial.

Correlation between gene expression and MRI STIR signals in patients with chronic low back pain and Modic changes indicates immune involvement.

Disability and distress caused by chronic low back pain (LBP) lacking clear pathoanatomical explanations cause huge problems both for patients and society. A subgroup of patients has Modic changes (MC), identifiable by MRI as vertebral bone marrow lesions. The cause of such changes and their relationship to pain are not yet understood.

Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial.

Importance: Proactive therapeutic drug monitoring (TDM), consisting of individualized treatment based on scheduled assessments of serum drug levels, has been proposed as an alternative to standard therapy to optimize efficacy and safety of infliximab and other biologic drugs. However, it remains unclear whether proactive TDM improves clinical outcomes during maintenance therapy.

Objective: To assess whether proactive TDM during maintenance therapy with infliximab improves treatment efficacy by preventing disease worsening compared with standard infliximab therapy without TDM.

Impact of rescue medication in placebo-controlled trials of pharmacotherapy for neuropathic pain and low back pain.

Rescue medication (RM) consumption is commonly used as a secondary outcome in placebo-controlled trials of chronic pain, but its validity has yet to be established. If participants randomized to placebo take more RM than those randomized to an active drug, the difference in pain between the 2 groups may be reduced, potentially masking effects of the active drug. This study assessed proportional RM consumption in the placebo and active groups according to results of 42 randomized controlled trials of neuropathic pain (NeP), and 29 trials of low back pain, which were included in 2 systematic reviews and meta-analyses.

Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial.

Importance: Proactive therapeutic drug monitoring (TDM), defined as individualized drug dosing based on scheduled monitoring of serum drug levels, has been proposed as an alternative to standard therapy to maximize efficacy and safety of infliximab and other biological drugs. However, whether proactive TDM improves clinical outcomes when implemented at the time of drug initiation, compared with standard therapy, remains unclear.

Objective: To assess whether TDM during initiation of infliximab therapy improves treatment efficacy compared with standard infliximab therapy without TDM.

Pinprick and Light Touch Are Adequate to Establish Sensory Dysfunction in Patients with Lumbar Radicular Pain and Disc Herniation.

Background: The frequency with which sensory disturbances occur in patients with radicular leg pain and disc herniation is not well known, and the efficacy of tests to identify such changes are not firmly established. The presence of sensory disturbances is a key sign of nerve root involvement and may contribute to the diagnosis of a lumbar disc herniation, identify patients for referral to spinal imaging and surgery, and improve disease classification.

Questions/purposes: In this study, we sought: (1) to determine the frequency with which abnormal sensory findings occur in patients with lumbar disc herniation-related radicular pain, using a standard neurological sensory examination; (2) to determine what particular standard sensory test or combination of tests is most effective in establishing sensory dysfunction; and (3) to determine whether a more detailed in-depth sensory examination results in more patients being identified as having abnormal sensory findings.

The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial.

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.

Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study).

Background: Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation.

Association of Modic change types and their short tau inversion recovery signals with clinical characteristics- a cross sectional study of chronic low back pain patients in the AIM-study.

Background: Modic Changes (MCs, magnetic resonance imaging (MRI) signal changes in the vertebral bone marrow extending from the vertebral endplate) may represent a subgroup of nonspecific chronic low back pain that could benefit from a specific management. The primary aim was to compare clinical characteristics between patients with type 1 versus type 2 MCs. The secondary aim was to explore associations between clinical characteristics and MC related short tau inversion recovery (STIR) signals.

Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial.

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.

Rescue and concomitant analgesics in placebo-controlled trials of pharmacotherapy for neuropathic pain and low back pain.

Rescue medication is commonly offered to participants in placebo-controlled trials of analgesic drugs. The use of pain medication in addition to the placebo or experimental drug may complicate the interpretation of effects and tolerability, but this issue has received little methodological attention. This study examined the handling and reporting of rescue and concomitant analgesic use in trials of pharmacotherapy for neuropathic pain and low back pain.

New insight to the characteristics and clinical course of clusters of patients with imaging confirmed disc-related sciatica.

Background: Referral to secondary care is common for a considerable proportion of patients with persistent sciatica symptoms. It is unclear if information from clinical assessment can further identify distinct subgroups of disc-related sciatica, with perhaps different clinical courses.

Aims: This study aims to identify and describe clusters of imaging confirmed disc-related sciatica patients using latent class analysis, and compare their clinical course.

Up-regulation of circulating microRNA-17 is associated with lumbar radicular pain following disc herniation.

Background: Previous studies suggest that regulatory microRNAs (miRs) may modulate neuro-inflammatory processes. The purpose of the present study was to examine the role of miR-17 following intervertebral disc herniation.

Methods: In a cohort of 97 patients with leg pain and disc herniation verified on MRI, we investigated the association between circulating miR-17 and leg pain intensity.

Cross-cultural Adaptation and Validation of the Norwegian Short-form McGill Pain Questionnaire-2 in Low Back-related Leg Pain.

Study Design: A prospective observational study with translation and psychometric analyses of a questionnaire.

Objective: Cross-cultural adaptation of the Short-Form McGill Pain Questionnaire-2 into Norwegian.

Summary Of Background Data: The different versions of the McGill Pain Questionnaire (MPQ) have been important and influential tools for pain assessment.

The Rates of LSS Surgery in Norwegian Public Hospitals: A Threefold Increase From 1999 to 2013.

Study Design: Retrospective administrative database study.

Objective: To assess temporal and regional trends, and length of hospital stay, in lumbar spinal stenosis (LSS) surgery in Norwegian public hospitals from 1999 to 2013.

Summary Of Background Data: Studies from several countries have reported increasing rates of LSS surgery over the last decades.

Treat to target strategy in early rheumatoid arthritis versus routine care - A comparative clinical practice study.

Objective: To assess the 2-year effect on disease activity and health-related quality of life (HRQoL) of implementing a clinical practice treat-to-target (T2T) strategy in patients with rheumatoid arthritis (RA).

Methods: Patients in the Norwegian Very Early Arthritis Cohort 2.0 (NOR-VEAC 2.