Condition category
Nervous System Diseases
Date applied
27/05/2019
Date assigned
04/07/2019
Last edited
16/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 August 2019.

Who is funding the study?
Investigator funded

Who is the main contact?
Dr Deborah Galvin,
deborahgalvin@yahoo.ie

Trial website

Contact information

Type

Public

Primary contact

Dr Deborah Galvin

ORCID ID

http://orcid.org/0000-0002-3506-195X

Contact details

39 Gledswood Avenue
Clonskeagh
D14C8Y8
Ireland
+353 1 4163952
deborahgalvin@yahoo.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2016-12 List 47 97, 2018-10 List 33

Study information

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

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

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).

Study design

Cross-sectional observational trial

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

03/09/2018

Overall trial end date

23/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Chronic radicular pain
2. Scheduled to undergo pulsed radiofrequency treatment (PRF).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

Coagulopathy

Recruitment start date

24/10/2018

Recruitment end date

23/08/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

St James Hospital
Dept. of Pain James Street
Dublin
D8
Ireland

Sponsor information

Organisation

Trinity Translational Medicine Institute

Sponsor details

Trinity College Dublin
The University of Dublin
St. James’s Hospital
Dublin
D8
Ireland
+353 863599013
deborahgalvin@yahoo.ie

Sponsor type

University/education

Website

https://www.tcd.ie/ttmi

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Aiming for International Pain Journal or Immunology Journal

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/06/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.