Objectives: To evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and performance-based).
Design: A single-centre, three-armed, randomised controlled feasibility trial with a parallel design, with follow-up after 3 and 6 months.
Importance: The ability of surgeons to choose the right patient for fusion in addition to decompression when operating for degenerative spondylolisthesis with symptomatic spinal stenosis is debated. The addition of fusion increases risk, morbidity, and costs but has been claimed to give better results for selected patients.
Objective: To investigate whether following surgeons' opinions regarding fusion was associated with clinical outcomes.
Objective: The efficacy of tumor necrosis factor 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 type 1 changes.
Methods: In this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022.
Purpose: The short-term clinical outcome for midline-preserving posterior decompression techniques was comparable. The aim of this study was to evaluate long-term clinical results after three different midline-preserving posterior decompression techniques.
Material: In the NORDSTEN spinal stenosis trial (NORDSTEN-SST) 437 patients were randomized to three different midline-retaining posterior decompression techniques: Unilateral laminotomy with crossover (UL), bilateral laminotomy (BL) and spinous process osteotomy (SPO).
Study Design: Post-hoc analysis of data from a randomized clinical trial.
Objective: To compare preoperative symptoms of patients with lumbar spinal stenosis (LSS) with and without redundant nerve roots (RNR), and to compare the change in clinical outcomes between those two groups 2 years after decompression surgery.
Summary Of Background Data: RNR are often seen on MRI in patients with spinal stenosis.
Eur Spine J
November 2024
Background: Most patients with cervical radiculopathy improve within the first months without treatment or with non-surgical treatment. A systematic review concluded that these patients improve, regardless of their intervention. Still, many patients are offered surgery, despite limited evidence regarding the indications for surgical treatments.
View Article and Find Full Text PDFObjective: To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.
Design: Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).
Setting: 16 public orthopaedic and neurosurgical clinics in Norway.
Purpose: To evaluate responsiveness and minimal important change (MIC) of Oswestry Disability Index (ODI), pain during activity on a numeric rating scale (NRSa) and health related quality of life (EQ-5D) based on data from the Norwegian neck and back registry (NNRR).
Methods: A total of 1617 patients who responded to NNRR follow-up after both 6 and 12 months were included in this study. Responsiveness was calculated using standardized response mean and area under the receiver operating characteristic (ROC) curve.
Objective: To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal disorders and to describe the trials' clinical and design characteristics.
Design: A systematic review of published trials and trials submitted to public registries.
Data Sources: The databases Medline, Cochrane Library and McMaster; six public clinical registries.
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.
View Article and Find Full Text PDFBackground: Lumbar spinal stenosis is a prevalent and increasingly important cause of low back pain, leg pain, and walking impairment. Minimally invasive decompressive techniques such as spinous process (SP) osteotomy have become more common in recent years. The main aim of this study was to investigate the proportion of complete SP union and whether complete radiological healing after the osteotomy is associated with superior clinical outcome after 2 years.
View Article and Find Full Text PDFBack and neck pain are common in the population, especially among immigrants. In Norway's specialist care system, treating these patients typically involves a multidisciplinary approach based on the biopsychosocial model. However, language and cultural differences may create barriers to participation.
View Article and Find Full Text PDFBackground: Lumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome.
View Article and Find Full Text PDFPurpose: To evaluate and compare responsiveness characteristics for the Foot Function Index revised short form (FFI-RS), RAND-12 Health Status Inventory (RAND-12), and Numeric Rating Scale (NRS), in patients with plantar fasciopathy receiving non-surgical treatment.
Materials And Methods: This study was conducted on a sub-group of patients from an ongoing randomised controlled trial. One-hundred fifteen patients were included.
BMJ
October 2023
Objective: To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder.
Design: Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months.
Setting: Six hospitals in Norway and Sweden.
BMC Musculoskelet Disord
September 2023
Background: Greater Trochanteric Pain Syndrome (GTPS) is a common chronic musculoskeletal condition that may affect physical function, quality of life and sleep. The Victorian Institute of Sport Assessment-Gluteal questionnaire (VISA-G) has been developed as a Patient-Reported Outcome Measurement (PROM) to address pain, everyday activities, physical activities, and difficulty with weight bearing activities. The aim of the study was to test the reliability, validity and floor and ceiling effects of the Norwegian version of the VISA-G (VISA-G-Norwegian) in a population with GTPS in a specialist health care setting.
View Article and Find Full Text PDFPurpose: To review and describe the development, methods and cohort of the lumbosacral part of the Norwegian registry for spine surgery (NORspine).
Methods: NORspine was established in 2007. It is government funded, covers all providers and captures consecutive cases undergoing operations for degenerative disorders.
Purpose: To provide an overview of the The Norwegian Degenerative spondylolisthesis and spinal stenosis (NORDSTEN)-study and the organizational structure, and to evaluate the study population.
Methods: The NORDSTEN is a multicentre study with 10 year follow-up, conducted at 18 public hospitals. NORDSTEN includes three studies: (1) The randomized spinal stenosis trial comparing the impact of three different decompression techniques; (2) the randomized degenerative spondylolisthesis trial investigating whether decompression surgery alone is as good as decompression with instrumented fusion; (3) the observational cohort tracking the natural course of LSS in patients without planned surgical treatment.