The Causes of Failure in Spinal Cord Stimulation.
Research type
Research Study
Full title
A study exploring the causes of failure in patients with permanent spinal cord stimulation implants
IRAS ID
297143
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
Approximately 1/3 of adults in the UK suffer from chronic pain. For patients who fail to benefit from standard treatments, such as pharmacological and psychological therapies, spinal cord stimulation (SCS) may be considered.
A spinal cord stimulator is an surgically-inserted invasive device which sends mild electric shocks to relieve chronic pain. Currently, around 30% of SCS implants fail, i.e. the patient experiences a pain reduction of less than 50% or is dissatisfied with their implant. This study aims to understand why this failure occurs. It will consist of both qualitative and quantitative data.
Patients whose SCS treatment has 'failed' will be identified from the LTHTR database of SCS patients and sent participant information sheets to inform them about the study and invite them to take part.
A 15-20-minute semi-structured interview will be used speak to patients about why they believe their SCS treatment failed. This interview will also explore the impact of the failure on their life and whether they wish anything could have been done differently prior to the implant.
In addition, a scoring system, previously investigated by the LTHTR pain team, will be used to explore some of the possible functional (e.g. functional status, pain condition), physical (e.g. BMI, age) and psychosocial (e.g. psychological set-up, education) risk factors contributing to SCS failure.
The data collected from the interviews will be transcribed and analysed using thematic analysis. This data will be combined with the data collected from the scoring system in order to better understand the reasons for spinal cord stimulation failure.
This research can be used by clinicians to better predict SCS outcomes in the future. Furthermore, it can help to identify and manage some of the causes of SCS failure in order to improve patient care.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0113
Date of REC Opinion
28 Apr 2021
REC opinion
Further Information Favourable Opinion