Predicting the long term outcomes of spinal cord stimulation.
Research type
Research Study
Full title
A pilot study looking at the correlation of physical, functional, psychological and social factors to the long term outcome following Spinal cord stimulation therapy for failed back surgery syndrome.
IRAS ID
242805
Contact name
Shiva Tripathi
Contact email
Sponsor organisation
Lancashire Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Title: Can a scoring system be used to predict the long-term outcome for patients who have had spinal cord stimulation?
Background: The Spinal Cord Stimulation (SCS) treatment is applicable to many people, yet the twelve month success rate varies, ranging from 43% to 84% [2][3][4]. The exact physiology is still uncertain but it has been observed that some factors such as body mass index (BMI), smoking and psychological factors are predisposed to high failure rates [11][12][13]. In order to maximise the success rate, having an evidence based scoring system creates the potential to predict the long term outcome of the treatment. We will trial a scoring system to aid in referring only the most suitable patients for spinal stimulation and therefore to maximize its success rate.
Design: An observational study using medical records and patient interviews to capture information to input into a scoring system to predict outcomes following SCS treatment.
Sample: Patients who have had SCS treatment at Lancashire Teaching Hospitals NHS Foundation Trust.
Recruitment: Potential participants will be identified from a chronic pain database at the hospital and informed about the study by letters of invitation together with the participant information sheet. If they consent to participate a retrospective analysis of their medical records will be carried out to determine their status before receiving spinal cord stimulation. Patients will then be invited for either a face-to-face or a telephone interview where they will be asked a series of questions about their current pain status and about changes to their health status following spinal cord stimulation. This information will be collated onto the scoring system.
Analysis: The information will then be analysed using either binary logistic regression or a survival analysis model to determine the long-term outcome of spinal cord stimulation in the selected patients.
REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/0449
Date of REC Opinion
28 Mar 2018
REC opinion
Further Information Favourable Opinion