QST and Neuropathic Pain

NCT03806010 | Completed

• 1 other identifier: 15/LO/2094
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Quantitative sensory testing

Outcome Measures

Primary Outcomes (1)

• • 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 (3)

• • 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 •

  2 weeks 3, 6 months and one year

• The effect on functionality and quality of life following chronic pain intervention

  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)

  2 weeks and 3, 6 months and 1 year

Study Arms (1)

Quantitative sensory testing

QST will be performed at baseline two weeks and 2 months

Procedure: Quantitative sensory testing

Interventions

Quantitative sensory testing PROCEDURE

Quantitative sensory testing

Quantitative sensory testing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic pain of at leasr 6 months

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Dr Theresa Wodehouse

London, Essex, ec1a 7be, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• vIVEK mEHTA, MD

  Barts NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 11, 2020

Record last verified: 2019-01

Locations

GB (1)