Micro evaluation of temporary lead placed for spinal cord stimulation
Research type
Research Study
Full title
Microbiological evaluation of the temporary lead in cut down spinal cord stimulator procedures: A pilot study
IRAS ID
141052
Contact name
A Lalkhen
Contact email
Sponsor organisation
Salford Royal NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Pain is felt when there is damage to a given part of the body. The body uses nerves to detect painful/harmful things which carries these sensations as electrical current to the brain. To reach the brain, the different nerves in the body travel through the spinal cord.
Chronic pain is defined as pain that has existed for several months. This is associated with harsh consequences for patients as well as healthcare costs.
Spinal cord stimulation is a treatment for chronic pain. This involves placing 2 metal wires (electrodes) into the space surrounding the spinal cord (called the epidural space). Passing electrical currents through these electrodes stops the spinal cord carrying painful nerve signals from specific areas of the body.
The placement of a spinal cord stimulator occurs in 2 phases.
-The electrodes are placed in epidural space and are connected to a battery via temporary extension wires. The system is activated and the patient is allowed time (usually days) to assess whether the system has successfully treated their pain (trial phase).
-If the trial phase is successful, the patient is brought back to the hospital and the temporary extension wires are replaced with permanent extension wires (permanent phase). The temporary extension wires are usually then disposed of.One of the potential complications of this treatment is infection. The purpose of this study is to assess the number of patients whose temporary leads carry bacteria, and whether this correlates with future infection risk. These estimates will then be used to find out the number of patients we will need to perform a larger study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1295
Date of REC Opinion
19 Sep 2014
REC opinion
Favourable Opinion