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Completed

NCT Number: NCT03806010

QST and Neuropathic Pain

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Theresa Wodehouse

London, Essex, ec1a 7be, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative sensory testing

Procedure

Quantitative sensory testing

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.

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2019
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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