QST and Neuropathic Pain

• ClinicalTrials.gov Identifier: NCT03806010
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: August 11, 2020
• Sponsor: Barts & The London NHS Trust
• Information provided by (Responsible Party): Barts & The London NHS Trust

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Pain	Procedure: Quantitative sensory testing

Study Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Open Labelled Study to Evaluate if Central Sensitization as Measured With QST Alters Following Chronic Pain Interventions
• Actual Study Start Date: February 1, 2016
• Actual Primary Completion Date: February 1, 2019
• Actual Study Completion Date: February 1, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: QST changes at 4 weeks is taken as primary objective. ]
   This is assessed by comparing and reporting any change in QST results before and after the intervention.

Secondary Outcome Measures :

1. • 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 • [ Time Frame: 2 weeks 3, 6 months and one year ]
   QST changes
2. The effect on functionality and quality of life following chronic pain intervention [ Time Frame: 2 weeks and 3, 6 months and 1 year. ]
   QST changes
3. 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) [ Time Frame: 2 weeks and 3, 6 months and 1 year ]
   QST changes

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Chronic pain of at leasr 6 months

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

Contacts and Locations

Locations

United Kingdom

Dr Theresa Wodehouse

London, Essex, United Kingdom, ec1a 7be

Sponsors and Collaborators

Barts & The London NHS Trust

Investigators

• Principal Investigator: vIVEK mEHTA, MD; Barts NHS Trust

More Information

• Responsible Party: Barts & The London NHS Trust
• ClinicalTrials.gov Identifier: NCT03806010
• Other Study ID Numbers: 15/LO/2094
• First Posted: January 16, 2019
• Last Update Posted: August 11, 2020
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barts & The London NHS Trust:

Quantitative sensory testing

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations