Neuropathic PainCSF-STIMNCT03986255
Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation in Subjects Suffering From Chronic Refractory Pain Conditions
A study testing Lumbar Puncture in people with Neuropathic Pain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Lumbar Puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Mar 2019to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Structural abnormalities of the spine at L2-L3 that may impact study procedure
- Severe scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation: A Single Centre, Prospective, Exploratory Study in Subjects Suffering From Chronic Refractory Pain Conditions
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.
Read the detailed 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.
- Conditions
- Neuropathic Pain
- Being tested
- Lumbar Puncture
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar PunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Puncture | Experimental | Participants will undergo Lumbar puncture procedure Receives: Procedure: Lumbar Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start19 Mar 2019
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Why it stopped: Study terminated early at the request of Sponsors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986255
- Sponsor's protocol ID
- CSF-STIM v1.0 22/OCT/2018
- Other IDs
- CSF-STIM
- Acronym
- CSF-STIM
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2019
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation: A Single Centre, Prospective, Exploratory Study in Subjects Suffering From Chronic Refractory Pain Conditions
- ClinicalTrials.gov ID
- NCT03986255
- Acronym / sponsor ID
- CSF-STIM / CSF-STIM v1.0 22/OCT/2018
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early at the request of Sponsors.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar Puncture | Experimental | Procedure: Lumbar PunctureParticipants will undergo Lumbar puncture procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Structural abnormalities of the spine at L2-L3 that may impact study procedure
- Severe scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar PunctureThe 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. | Procedure or surgery | Lumbar Puncture |
Primary outcome
Pain VAS
Time frame: 6 Months
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.
Pain Map
Time frame: 6 Months
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.
Oswestry Disability Index (ODI)
Time frame: 6 Months
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.
Patient Global Impression of Change (PGIC)
Time frame: 6 Months
Questionnaire used to assess patient satisfaction Participants will be asked to complete this questionnaires at follow up visits. .
Douleur Neuropathique 4 (DN4)
Time frame: 6 Months
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.
EQ-5D-5L
Time frame: 6 Months
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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 Months
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.
Results and safety
The study was stopped early (reason given: Study terminated early at the request of Sponsors.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Puncture in people with Neuropathic Pain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated early at the request of Sponsors.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS (time frame: 6 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.