Clinical Trials Logo

Clinical Trial Summary

Spinal cord stimulation (SCS) is a medical device inserted beside the spine to treat nerve pain. When the device becomes infected (which happens 4 % of the time) it needs to be taken out and put back in again at a later date. So far we are unsure of how much this process costs. I am going to analyse data collected on a database of all devices taken out due to infection and calculate an average cost of taking them out, the intermediate care and putting them back in again in our hospital only. This will enable us to understand how much this process costs and if there are any methods of reducing the chance of infection in the future; we will be able to work out how much the NHS should pay for these products based on this data. This will be done in Guys and St Thomas's from a database in the chronic pain research department in patients who had their device taken out due to infection. It will take 6 months and will all be retrospective. Additional details may be collected from patients electronic records where needed. These will be collected by a member of the direct care team and pseudonymised prior to adding to the research data set.


Clinical Trial Description

Design: Retrospective chart and electronic record review of all explants due to infection with cost analysis up to re-implantation. Methods: Based on a database there are approximately N=18-20 infections over 7 years with adequate data to determine the overall cost of explant due to infection. The data to be collected will include: hospital admission, surgical time, blood tests, swabs, antibiotic therapy, additional outpatient visits, cost of re-implantation. These can be collected from electronic patient records (EPR). The cost of individual patient admissions will be obtained from the account services at Guys and St Thomas's and sent in a password protected database. The site of infection will also be recorded and this can be obtained from the operative note. A study by Hayek and colleagues have indicated only 10% of infections are at the lead site and the majority are at the IPG site. Another review by Follet and colleagues have indicated only 54% of infections are at the IPG site, 17% at the lead site and the others not clearly determined. For this reason, there will need to be a range of costs based on the confirmed and the indeterminate sites of infection. The main focus of this paper will be on IPG infections since TYRX is only used at the IPG site. Economic metrics will also be taken into consideration which have been described in the UK as some patients for technical reasons cannot be re-implanted with SCS systems after infection. The cost effectiveness of this therapy is essentially lost in these patients forever. The time proceeding to re-implantation can also be reviewed and incorporated. There was an NIHR review of cost analysis of these systems published in the UK that can be used for this. Specifically the cost of SCS and conventional medical management (CMM) is £3440 in year one of these devices and CMM alone is £6936. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05735574
Study type Observational
Source Guy's and St Thomas' NHS Foundation Trust
Contact Jonathan Royds, MB MD
Phone +44 20 7188 7188
Email jonathan.royds@gstt.nhs.uk
Status Not yet recruiting
Phase
Start date March 1, 2023
Completion date April 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain