Study Results
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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COMPLETED
10 participants
OBSERVATIONAL
2016-02-01
2019-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Quantitative sensory testing
QST will be performed at baseline two weeks and 2 months
Quantitative sensory testing
Quantitative sensory testing
Interventions
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Quantitative sensory testing
Quantitative sensory testing
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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15/LO/2094
Identifier Type: -
Identifier Source: org_study_id
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