TerminatedNot Applicable

Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation in Subjects Suffering From Chronic Refractory Pain Conditions

Stopped: Study terminated early at the request of Sponsors.

United Kingdom9 participantsStarted 2019-03-19

Plain-language summary

This is a single center exploratory study in subjects suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF). The study aims to identify any form of correlation between biological content of CSF and pain/treatment success. The study population include individuals suffering from chronic pain which has not been effectively treated with pharmacological treatment, medical intervention or alternative non-invasive treatments who have been scheduled for spinal cord stimulation.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be capable of understanding and signing a written consent form
. Subjects suffering from chronic neuropathic pain which has not been effectively managed with pharmacotherapy, medical interventions or alternative non-invasive treatments
. Pain VAS score ≥ 5 on more than 3 days a week at least over three months.
. Subjects deemed a suitable candidate receive spinal cord stimulator device as determined by a pain management specialist
. No known contraindication to spinal cord stimulation
. Does not have an active systemic or local infection

Exclusion criteria

. Structural abnormalities of the spine at L2-L3 that may impact study procedure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain VAS

Timeframe: 6 Months

Pain Map

Timeframe: 6 Months

Oswestry Disability Index (ODI)

Timeframe: 6 Months

Patient Global Impression of Change (PGIC)

Timeframe: 6 Months

Douleur Neuropathique 4 (DN4)

Timeframe: 6 Months

EQ-5D-5L

Timeframe: 6 Months

Pittsburgh Sleep Quality Index (PSQI)

Timeframe: 6 Months

Trial details

NCT IDNCT03986255

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-20

View on ClinicalTrials.gov More Neuropathic Pain trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be capable of understanding and signing a written consent form
. Subjects suffering from chronic neuropathic pain which has not been effectively managed with pharmacotherapy, medical interventions or alternative non-invasive treatments
. Pain VAS score ≥ 5 on more than 3 days a week at least over three months.
. Subjects deemed a suitable candidate receive spinal cord stimulator device as determined by a pain management specialist
. No known contraindication to spinal cord stimulation
. Does not have an active systemic or local infection

Exclusion criteria

. Structural abnormalities of the spine at L2-L3 that may impact study procedure

What they're measuring

Pain VAS

Timeframe: 6 Months

Pain Map

Timeframe: 6 Months

Oswestry Disability Index (ODI)

Timeframe: 6 Months

Patient Global Impression of Change (PGIC)

Timeframe: 6 Months

Douleur Neuropathique 4 (DN4)

Timeframe: 6 Months

EQ-5D-5L

Timeframe: 6 Months

Pittsburgh Sleep Quality Index (PSQI)

Timeframe: 6 Months