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

SexALL

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
✕. Severe scoliosis

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

SexALL

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
✕. Severe scoliosis

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