Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations. We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria.Background
Methods
The musculoskeletal system is a common, but often overlooked, cause of chest pain. Little is known about the efficacy of spinal manipulation for this condition. The purpose of the present study is to evaluate the relative effectiveness of two conservative treatment approaches for acute musculoskeletal chest pain, 1) a spinal manipulation-based therapy as a typical example of chiropractic treatment and 2) self-management as an example of minimal intervention. In a non-blinded, randomised controlled trial set at an emergency cardiology department and four outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to four weeks of chiropractic treatment or self-management, with post-treatment questionnaire follow-up four and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). Secondary measures included Medical Outcomes Study Short Form 36 (SF-36) scores, change in pain intensity (chest, thoracic spine, neck and shoulder/arm), and self-perceived change in general health. Preliminary results will be available at the time of presentation.Background and purpose
Methods and results
To identify any difference in clinical outcome between Intra-Capsular facet (IF) and Peri-facet (PF) injections in patients with low back pain (LBP). IF and PF joint steroid injections have been used for treatment of LBP with varied reports of pain relief for many years. Patients randomised into IF and PF groups. Bilateral L4/5 and L5/S1 levels injected. 40mg of Depo-Medrone with Lignocaine (total 1ml) in IF group. 80mg of Depo-Medrone with 1ml of 0.5% Chirocaine (total 3ml) in PF group. Pain visual analogue score (VAS) and analgesic chart – completed till six months.Objective
Methods
Sleep disturbance is a prevalent symptom in people with chronic low back pain (CLBP >12 weeks), but there is currently no knowledge of the effectiveness of physiotherapy for this problem. This study evaluated the feasibility of a randomised controlled trial (RCT) exploring the effects of physiotherapy on sleep disturbance in CLBP [Current controlled trial ISRCTN 54009836]. A sample of 60 consenting patients with CLBP [23 M, 37 F; mean (SD) age = 44.93 (13.41) years] were recruited in Beaumont Hospital, Dublin and randomly allocated to one of three groups [supervised exercise class (SEC), walking programme (WP) and usual physiotherapy (UP)] in a concealed manner. The main outcomes were sleep quality, functional disability, pain, and quality of life at baseline, 3 and 6 months.Background and purpose
Methods
Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain. The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure. This was a blinded parallel two-arm pilot randomised controlled trial. Adult patients referred to the pain and orthopaedic clinics at Barts Health NHS Trust with non-specific low back pain of at least three months' duration were considered for inclusion. Participants who had a positive result following diagnostic single medial branch nerve blocks were randomised to receive either intra-articular lumbar facet-joint injections with steroid or a sham procedure. All participants were invited to attend a combined physical and psychological programme. Questionnaires were used to assess a range of pain and disability-related issues. Healthcare utilisation and cost data were also assessed. Of 628 participants screened for eligibility, 9 were randomised to receive the study intervention and 8 participants completed the study.Purposes of the study and background
Summary of methods and results
Purpose of the study. To investigate the feasibility of undertaking a definitive
