QST and Neuropathic Pain

NCT ID: NCT03806010

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2019-02-01

Brief Summary

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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

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Quantitative sensory testing

QST will be performed at baseline two weeks and 2 months

Quantitative sensory testing

Intervention Type PROCEDURE

Quantitative sensory testing

Interventions

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Quantitative sensory testing

Quantitative sensory testing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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vIVEK mEHTA, MD

Role: PRINCIPAL_INVESTIGATOR

Barts NHS Trust

Locations

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Dr Theresa Wodehouse

London, Essex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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15/LO/2094

Identifier Type: -

Identifier Source: org_study_id

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