Chronic PainNCT03806010
QST and Neuropathic Pain
An observational study of Chronic Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Quantitative sensory testing
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2016to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic pain of at leasr 6 months
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Quantitative sensory testing
- Keywords
- Quantitative sensory testing
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testingProcedure or surgery
Quantitative sensory testing
| Study group | Role | What they receive |
|---|---|---|
| Quantitative sensory testing | QST will be performed at baseline two weeks and 2 months Receives: Procedure: Quantitative sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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 •
QST changes
Measured: 2 weeks 3, 6 months and one year
The effect on functionality and quality of life following chronic pain intervention
QST changes
Measured: 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
Measured: 2 weeks and 3, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Feb 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- vIVEK mEHTA, MD, Principal investigator, Barts NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806010
- Sponsor's protocol ID
- 15/LO/2094
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open Labelled Study to Evaluate if Central Sensitization as Measured With QST Alters Following Chronic Pain Interventions
- ClinicalTrials.gov ID
- NCT03806010
- Acronym / sponsor ID
- 15/LO/2094
- Conditions
- Chronic Pain
- Keywords
- Quantitative sensory testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quantitative sensory testing | – | Procedure: Quantitative sensory testingQST will be performed at baseline two weeks and 2 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain of at leasr 6 months
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative sensory testingQuantitative sensory testing | Procedure or surgery | Quantitative sensory testing |
Primary outcome
• 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.
3 secondary outcomes
• 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
The effect on functionality and quality of life following chronic pain intervention
Time frame: 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)
Time frame: 2 weeks and 3, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
vIVEK mEHTA, MD principal investigator
Barts NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.