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

NCT03986255 | Terminated

• 2 other identifiers: CSF-STIM v1.0 22/OCT/2018CSF-STIM
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (7)

• Pain VAS

  Visual Analogue Scale (VAS) used to assess improvements in pain. It is a continuous scale comprised of a horizontal line which is 10 centimeters (100mm) in length, anchored by 2 verbal descriptors, one which is no pain and the other worst imaginable pain. Lower scores denote a better outcome. Participants will be asked to complete this questionnaires at baseline and follow up visits.

  6 Months

• Pain Map

  A pain checklist with a list of anatomical locations from which the participants selects relevant sites to the site of his/her pain. It is used to assess location of pain. Participants will be asked to complete this questionnaires at baseline and follow up visits.

  6 Months

• Oswestry Disability Index (ODI)

  A self completed questionnaire used to assess changes in disability and health. The participants checks the statements which most closely resembles their situation. The scores for all the questions are summed with lower scores denote no disability. Participants will be asked to complete this questionnaires at baseline and follow up visits.

  6 Months

• Patient Global Impression of Change (PGIC)

  Questionnaire used to assess patient satisfaction Participants will be asked to complete this questionnaires at follow up visits. .

  6 Months

• Douleur Neuropathique 4 (DN4)

  A clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The questionnaire used to assess neuropathic pain Participants will be asked to complete this questionnaires at baseline and follow up visits.

  6 Months

• EQ-5D-5L

  A self report questionnaire used to assess improvements in quality of life. Participants will be asked to complete this questionnaires at baseline and follow up visits.

  6 Months

• Pittsburgh Sleep Quality Index (PSQI)

  A self report questionnaire that will used to assess improvements in sleep quality. The questionnaire consists of 19 items which measures several different aspects of sleep. Each item is weighted on a 0 - 3 interval scale, the overall score is calculated by totalling the seven component scores. Lower scores denote a healthier sleep quality Participants will be asked to complete this questionnaires at baseline and follow up visits.

  6 Months

Study Arms (1)

Lumbar Puncture

EXPERIMENTAL

Participants will undergo Lumbar puncture procedure

Procedure: Lumbar Puncture

Interventions

Lumbar Puncture PROCEDURE

The participant is placed lateral or sitting position. Fluoroscopy may be used to guide sampling. Full aseptic technique is used throughout. The skin is prepared with either 2% chlorhexidine/70% alcohol or iodine. 1% lidocaine is used for skin local anesthesia an entry point is identified, this may be done using fluoroscopy. This will be at the lowest intervertebral foramina interspace to minimize the risk of spinal cord injury. A small amount to head up tilt will be allowed to optimize CSF flow. Sampling is done using a "needle through needle" technique. An epidural needle is used to identify the epidural space using loss of resistance to saline technique. A spinal needle (26G) is then passed through the epidural needle into the subarachnoid space. Correct entry is noted once CSF is noted in the needle hub and 5 ml taken. This sample is then sent off for analysis. Once the CSF is sampled, the needle is removed and pressure applied to the skin entry point.

Lumbar Puncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: June 14, 2019
• Study Start: March 19, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

GB (1)