QST and Neuropathic Pain

A Prospective Open Labelled Study to Evaluate if Central Sensitization as Measured With QST Alters Following Chronic Pain Interventions

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: Quantitative sensory testing

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • London, Essex, United Kingdom, ec1a 7be
      • Dr Theresa Wodehouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic pain of at leasr 6 months

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quantitative sensory testing; QST will be performed at baseline two weeks and 2 months	Procedure: Quantitative sensory testing; Quantitative sensory testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	QST changes	2 weeks and 3, 6 months and 1 year.
Whether central sensitisation can be used as a bedside biomarker to predict outcome after interventions for chronic pain (i.e. the more centrally sensitised the more superior improvement from treatment)	QST changes	2 weeks and 3, 6 months and 1 year

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Principal Investigator: vIVEK mEHTA, MD, Barts NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Quantitative sensory testing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 15/LO/2094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No