Background: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.

Methods: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.

Results: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.

Conclusions: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.

Trial Registration: Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069989PMC
http://dx.doi.org/10.1186/s13063-018-2801-6DOI Listing

Publication Analysis

Top Keywords

randomised controlled
16
controlled trial
16
trial
8
trial adalimumab
8
tumour necrosis
8
internal pilot
8
randomised
5
controlled
5
adalimumab
5
treatment
5

Similar Publications

Introduction: Acute myocardial infarction (AMI) poses a significant global health burden, warranting meticulous management strategies, particularly in patients with concurrent anemia. Blood transfusion strategies play a pivotal role in optimizing oxygen delivery while minimizing transfusion-related risks. Two contrasting approaches, liberal and restrictive transfusion strategies, have emerged, yet their comparative effectiveness remains uncertain due to conflicting evidence.

View Article and Find Full Text PDF
Article Synopsis
  • The study aimed to explore how non-drug treatments affect sarcopenic obesity (SO) through a meta-analysis of randomized controlled trials (RCTs).
  • Results indicated that exercise and nutrition can improve various physical health metrics, such as body fat percentage (PBF) and grip strength, but individual interventions showed limited effectiveness.
  • The combination of exercise and nutritional interventions proved to be the most effective approach for improving outcomes related to SO, highlighting the potential role of physical therapy as well.
View Article and Find Full Text PDF

Background: High-quality bowel preparation is paramount for a successful colonoscopy. This study aimed to explore the effect of artificial intelligence-driven smartphone software on the quality of bowel preparation.

Methods: Firstly, we utilized 3305 valid liquid dung images collected mobile phones as training data.

View Article and Find Full Text PDF
Article Synopsis
  • The study aims to evaluate the feasibility of an exercise intervention for young people aged 13-17 with mild to moderate depression, comparing high-intensity exercise, low-intensity exercise, and social activities.
  • Participants were recruited through mental health services and schools, with the intervention delivered over 12 weeks by trained professionals.
  • Results showed a 71.4% retention rate and over 67% attendance, although only 14 participants were randomized from the initial referrals, indicating challenges in recruitment.
View Article and Find Full Text PDF

Identifying subgroups deriving the most benefit from PD-1 checkpoint inhibition plus chemotherapy in advanced metastatic triple-negative breast cancer: a systematic review and meta-analysis.

World J Surg Oncol

December 2024

Department of Radiation Oncology, Guangzhou Institute of Cancer Research, the Affiliated Cancer Hospital, Guangzhou, Guangdong, 510095, People's Republic of China.

Background: The combination of immunotherapy and chemotherapy has demonstrated an enhancement in progression-free survival (PFS) for individuals with advanced and metastatic triple-negative breast cancer (TNBC) when compared to the use of chemotherapy alone. Nevertheless, the extent to which different subgroups of metastatic TNBC patients experience this benefit remains uncertain.

Objectives: Our objective was to conduct subgroup analyses to more precisely identify the factors influencing these outcomes.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!