An investigation on spinal fluid in patients with sciatica-type or nerve-type pain of the lower limb
| ISRCTN | ISRCTN34007592 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34007592 |
| Secondary identifying numbers | 2016-12 List 47 97, 2018-10 List 33 |
- Submission date
- 27/05/2019
- Registration date
- 04/07/2019
- Last edited
- 17/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
PD-1 and PD-L1 are proteins found on the surface of cells that are involved in immune responses (defence against foreign substances) in the human body. We currently know, the cause of neuropathic pain is associated with an unusual immune response. Identification of these proteins in patients with neuropathic pain may suggest a potential target for the treatment of neuropathic pain in the future.
We aim to investigate the presence of PD-1 and PD-L1 in the spinal fluid of patients with neuropathic pain.
Who can participate?
Patients with chronic radicular pain who are scheduled to undergo pulsed radiofrequency treatment (PRF).
What does the study involve?
The study involves performing a lumbar puncture on patients with neuropathic pain, to sample cerebrospinal fluid (CSF) and perform flow cytometry analysis on these samples to identify if PD-1 and PD-L1 are present and on which cells.
What are the possible benefits and risks of participating?
Possible benefits include the identification of a new target for the treatment of neuropathic pain. All patients will have standard treatment given as currently recommended (PRF to DRG) and will be offered subsequent repeat procedure if a benefit is seen.
Potential risks include the 1 in 200 risk of developing a post dural puncture headache secondary to the lumbar puncture. The risk of this is reduced as much as possible by the use of the smallest lumbar puncture needle with needle least likely to cause tearing of spinal fibres.
Where is the study run from?
St James Hospital, Dublin.
When is the study starting and how long is it expected to run for?
October 2018 to July 2023
Who is funding the study?
Investigator funded
Who is the main contact?
Dr Deborah Galvin,
deborahgalvin@yahoo.ie
Contact information
Public
Trinity Translational Medicine Institute
Trinity Centre for Health Sciences Trinity College Dublin
St James’s Hospital
Dublin
8
Ireland
 ORCID ID |
0000-0002-3506-195X |
|---|---|
| Phone | +353 1 4163952 |
| deborahgalvin@yahoo.ie |
Study information
| Study design | Cross-sectional observational trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An investigation on cerebrospinal fluid (CSF) concentrations of PD-1 and PD-L1 and quantification of cellularity of CSF in patients with chronic radicular lumbar pain |
| Study acronym | PD 1 Study |
| Study hypothesis | To investigate the presence of PD-1 and PD-L1 in patients with chronic radicular lumbar pain |
| Ethics approval(s) | Approved 18/10/2019, SJH/TUH Research Ethics Committee (Tallaght University Hospital, Tallaght, Dublin 24, D24 NR0A; ResearchEthics@tuh.ie; +353(0)1-414 2199), ref: 2016-12 List 47 97, 2018-10 List 33 (10) (8). |
| Condition | Neuropathic lower limb pain |
| Intervention | Patients are undergoing pulsed radiofrequency treatment (PRF). CSF is taken at the time of the procedure (just before it is performed) via lumbar puncture with subsequent flow cytometry performed. It is performed by the principal investigator. (PRF consists of 120 seconds of electric current to the dorsal root ganglion (nerve root) of the spinal nerves in the back which results in a change in the activity or "firing" of the nerve. Routine follow-up is at 3 months post-procedure or sooner at patient request.) Follow-up data consists of all patients being routinely reviewed at an outpatient appointment 3 months later (consisting of direct questioning and a repeat completion of a neuropathic pain questionnaire called DN4- already completed by them prior to first CSF sampling). Contact details for the pain department are given to all participants after the procedure regarding any issues after the procedures. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Presence of PD-1 and PD-L1 in the patients spinal fluid (as quantified by flow cytometry) |
| Secondary outcome measures | Change in pain score of patient at 3 month interview and use of Douleur Neuropathique pain questionnaire at baseline (day of procedure) and 3 months later (when back in clinic) |
| Overall study start date | 03/09/2018 |
| Overall study end date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12 |
| Participant inclusion criteria | 1. Chronic radicular pain 2. Scheduled to undergo pulsed radiofrequency treatment (PRF). |
| Participant exclusion criteria | Coagulopathy |
| Recruitment start date | 24/10/2018 |
| Recruitment end date | 31/03/2023 |
Locations
Countries of recruitment
- Ireland
Study participating centre
James Street
Dublin
D8
Ireland
Sponsor information
University/education
Trinity College Dublin
The University of Dublin
St. James’s Hospital
Dublin
D8
Ireland
| Phone | +353 863599013 |
|---|---|
| deborahgalvin@yahoo.ie | |
| Website | https://www.tcd.ie/ttmi |
"ROR" |
https://ror.org/02tyrky19 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Aiming for International Pain Journal or Immunology Journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
17/11/2023: The study contact stated that recruitment into the study was suspended between March 2020 and December 2020 due to the COVID-19 pandemic and changed the following:
1. The overall study end date was changed from 23/08/2019 to 31/07/2023.
2. Recruitment end date was changed from 23/08/2019 to 31/03/2023.
3. The intention to publish date was changed from 01/06/2020 to 30/06/2024.
08/11/2019: The public contact address was updated.
16/08/2019: The recruitment end date was updated from 07/07/2019 to 23/08/2019.
04/06/2019: Trial’s existence confirmed by SJH/TUH Research Ethics Committee.
