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

Guy's and St Thomas' NHS Foundation Trust

Status: Terminated

Conditions: Neuropathic Pain

Treatments: Procedure: Lumbar Puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03986255

CSF-STIM (Other Identifier)

CSF-STIM v1.0 22/OCT/2018

Details and patient eligibility

About

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.

Full description

This is a single centre exploratory study in individuals suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).

The investigators aim to identify any form of correlation between biological content of CSF and pain/ spinal cord stimulator (SCS) therapy success. '

CSF will be sampled before and after SCS therapy, the samples will be analysed to explore and identify biomarkers that are potentially relevant to the chronic pain conditions

. All eligible participants who are enrolled in the study will undergo screening assessment. Specifically, assessments will include pain scores assessed by Visual Analogue Scale (VAS), quality of life as assessed by the EQ-5D, disability as assessed by the Oswestry Disability Index (ODI), quality of sleep as assessed by Pittsburgh Sleep Quality Index (PSQI), Pain sensation as assessed by Pain Map and neuropathic pain as assessed by Douleu Neuropathique 4 (DN4).

During trial implant participants will have CSF sample taken using lumbar puncture technique.

Following collection CSF sample will be analysed to Identify potential biomarkers.

All participants will return to the clinic 14 (± 7) days following the procedure to assess the outcome of their SCS trial and complete assessments which include Pain Map, Pain VAS, DN4 , PSQI , ODI , EQ-5D and Patients Global Impression of Change (PGIC).

Following this participants will be followed up for end of study visit. The second CSF sample will be taken at this visit using lumbar puncture technique. At this visit participants will further be asked to complete assessments including Pain Map, Pain VAS, DN4 , PSQI , ODI ,EQ-5D and PGIC.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Structural abnormalities of the spine at L2-L3 that may impact study procedure
2. Severe scoliosis

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Lumbar Puncture

Experimental group

Description:

Participants will undergo Lumbar puncture procedure

Treatment:

Procedure: Lumbar Puncture