QST and Neuropathic Pain | NCT03806010

Studies
QST and Neuropathic Pain

NCT03806010

Sponsor

Barts & The London NHS Trust

Status

Completed

Last Update Posted

Aug 11, 2020Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Chronic Pain

Interventions

Quantitative sensory testing

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2016Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Jan 14, 2019

First Submission Date that Met QC Criteria

Jan 14, 2019

First Posted Date

Jan 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2020

Last Update Posted Date

Aug 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To establish the sensory profile of patients using quantitative sensory testing (QST) and questionnaires as well as the level of sensitisation using temporal summation and diffuse noxious inhibitory control paradigms in all patients undergoing a chronic pain intervention at Barts Health NHS Trust.

Primary objective- To identify the phenotype of responders and non-responders to a chronic pain intervention using QST sensory profile as well as the sensitisation paradigms.

Secondary objective- To establish the correlation between sensory profile, and sensitisation parameters as well as other measures of chronic pain as per Initiative on Methods, Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation.

Common interventions performed at Barts Health NHS Trust includes Neuromodulation, targeted epidural steroid and/or radiofrequency treatment, 8% Capsaicin patch and pharmacological interventions such as anti-neuropathic agent and opioids.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quantitative sensory testing		QST will be performed at baseline two weeks and 2 months	Procedure: Quantitative sensory testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quantitative sensory testing	Procedure	Quantitative sensory testing	Quantitative sensory testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• To identify the phenotype of responders and non-responders to a chronic pain intervention using QST sensory profile as well as the sensitisation paradigms.	This is assessed by comparing and reporting any change in QST results before and after the intervention.	QST changes at 4 weeks is taken as primary objective.

Secondary Outcomes

Measure	Description	Time Frame
• To establish the correlation between sensory profile and sensitisation parameters as well as other measures of chronic pain as per Initiative on Methods, Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation •	QST changes	2 weeks 3, 6 months and one year
The effect on functionality and quality of life following chronic pain intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:• Male and female patients between the age of 18-80 years who have a lumbar radiculopathy who have not undergone any spinal surgery.

Minimum baseline pain rating of 50mm on a 100mm NRS in the painful area
Chronic pain of at least 6 months
Subject satisfies standard criteria in the study centre for SCS implantation and the NICE 159 criteria for management of intractable neuropathic pain.
Subject satisfies standard criteria in the study centre for ONS implantation and the NICE 452 criteria for intractable chronic migraine.
Patients who have given their written informed consent.
Patient is able and willing to comply with study procedures and follow up schedule.

Exclusion Criteria:• Any inclusion criteria not met

Female patients of childbearing age who is or plans on becoming pregnant during the course of the study
Patients who have undergone radiofrequency or injection therapy at or on a target neural structure (DRG) during the past 90 days
Patients with diabetes or any underlying neurological condition.
Patients known to have a condition that in the investigator's judgment precludes participation in the study.
Patients who have received an investigational drug or have used an investigational device in the 30 days preceding to study entry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic pain of at leasr 6 months

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
vIVEK mEHTA, MD	Barts NHS Trust	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Dr Theresa Wodehouse		London	Essex	ec1a 7be	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms