title: The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL study): study protocol for a pilot randomized controlled trial.
abstract: BACKGROUND
  The RASCAL (Refractory Angina Spinal Cord stimulation and usuAL care) pilot study seeks to assess the feasibility of a definitive trial to assess if addition of spinal cord stimulation (SCS) to usual care is clinically superior and more cost-effective than usual care alone in patients with refractory angina.
  
  
  METHODS
  This is an external pilot, patient-randomized controlled trial.The study will take place at three centers in the United Kingdom - South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital), Dudley Group of Hospitals NHS Foundation Trust, and Basildon and Thurrock University Hospitals NHS Foundation Trust.The subjects will be 45 adults with refractory angina, that is, limiting angina despite optimal anti-angina therapy, Canadian Cardiovascular Society Functional Classification Class III and IV, angiographically documented coronary artery disease not suitable for revascularization, satisfactory multidisciplinary assessment and demonstrable ischemia on functional testing.The study will be stratified by center, age and Canadian Cardiovascular Society Functional Classification.Interventions will involve spinal cord stimulation plus usual care ('SCS group') or usual care alone ('UC group'). Usual care received by both groups will include consideration of an education session with a pain consultant, trial of a transcutaneous electrical neurostimulation, serial thoracic sympathectomy and oral/systemic analgesics.Expected outcomes will be recruitment and retention rates; reasons for agreeing/declining participation; variability in primary and secondary outcomes (to inform power calculations for a definitive trial); and completion rates of outcome measures. Trial patient-related outcomes include disease-specific and generic health-related quality of life, angina exercise capacity, intake of angina medications, frequency of angina attacks, complications and adverse events, and satisfaction.
  
  
  CONCLUSIONS
  The RASCAL pilot trial seeks to determine the feasibility and design of a definitive randomized controlled trial comparing the addition of spinal cord stimulation to usual care versus usual care alone for patients with refractory angina.Fifteen patients have been recruited since recruitment opened in October 2011. The trial was originally scheduled to end in April 2013 but due to slow recruitment may have to be extended to late 2013.
  
  
  BACKGROUND
  ISRCTN65254102.
authors: Department of Pain and Anesthesia, The James Cook University Hospital, Marton Road, Middlesbrough, UK.
authors: Sam
authors: S
authors: Eldabe
authors: John
authors: J
authors: Raphael
authors: Simon
authors: S
authors: Thomson
authors: Andrea
authors: A
authors: Manca
authors: Mark
authors: M
authors: de Belder
authors: Rajesh
authors: R
authors: Aggarwal
authors: Matthew
authors: M
authors: Banks
authors: Morag
authors: M
authors: Brookes
authors: Susan
authors: S
authors: Merotra
authors: Rashidat
authors: R
authors: Adeniba
authors: Ed
authors: E
authors: Davies
authors: Rod S
authors: RS
authors: Taylor
mesh_terms: D006801:Humans; D000787:Angina Pectoris / Q000175:diagnosis / Q000188:drug therapy / Q000191:economics / Q000628:therapy; D002317:Cardiovascular Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004351:Drug Resistance; D004739:England; D005240:Feasibility Studies; D017048:Health Care Costs; D017060:Patient Satisfaction; D010865:Pilot Projects; D012107:Research Design; D062187:Spinal Cord Stimulation / Q000009:adverse effects / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic
chemical_list: D002317:Cardiovascular Agents