StrokeABBEY-FNCT04483141
Translation and Validation of the Abbey Pain Scale in Stroke Patients (ABBEY-F)
An observational study of Stroke and Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event. They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide range of patients have communication problems after stroke that make it difficult to assess pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Abbey Pain Scale
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2021to Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke
Who may be able to join
- at least 18 years old ;
- Covered by Social Security;
- Hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke;
- NIHSS score greater than 1;
- For communicating patients: French mother tongue, or reading French without assistance, and able to understand the objectives.
Who cannot join
- Refusal ;
- Legally protected patient
- Pregnancy;
- Pre-stroke psychiatric or neurodevelopmental disorders;
- Transient ischemic attack;
- Specific strokes: Bithalamic, locked-in syndrome.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Anna FERRIER
About this study
Official title: Translation and Validation of the Abbey Pain Scale in Stroke Patients
Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event. They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide range of patients have communication problems after stroke that make it difficult to assess pain. Yet there is a major impact of pain on the quality of life of these patients. Some tools have been validated to assess pain in non-communicative patients, but none are specific to stroke patients. The Algoplus scale is commonly used in intra-hospital care in France. The Abbey Pain Scale is not translated into French, and could provide a more accurate pain rating for non-communicative patients.
The objective is to validate a French version of the Abbey Pain Scale for stroke patients.
It is an observational study with longitudinal data collection. It is planned to include 120 patients from the neurology department of the Clermont-Ferrand University Hospital.
Read the detailed description
The study will be conducted over a 12-month period. 120 patients hospitalized for stroke including 60 communicating and 60 non-communicating patients will be recruited. Epidemiological data will be collected at enrollment, as well as an initial assessment using the Abbey and Algoplus scales for non-communicating and communicating patients, and also the numerical scale for communicating patients. The HADS questionnaire will be completed by communicating patients only. Of the 60 patients in each group, 30 will receive a second concurrent assessment by an inter-rater, 30 will receive a test/retest reassessment after 30 minutes, and 20 will be reassessed 90 minutes later by the same scales after pain treatment. For 30 of the 120 patients, an infrared pupillometry measurement will be performed before and after treatment of acute pain. All patients will be recruited from the neurovascular unit of the Clermont-Ferrand University Hospital.
- Being tested
- Abbey Pain Scale
- Keywords
- stroke, pain, aphasia, Abbey pain scale
- Medical subject headings
- Stroke, Pain, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbey Pain ScaleDiagnostic test
Hetero-assessment of pain
| Study group | Role | What they receive |
|---|---|---|
| non-communicant stroke patients | Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (hetero-assessment of pain). Receives: Diagnostic Test: Abbey Pain Scale | |
| communicant stroke patients | Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (including hetero-assessment and auto-assessment of pain) Receives: Diagnostic Test: Abbey Pain Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbey Pain Hetero-Evaluation Scale
This scale searches for elements suggestive of pain in the patient by scoring between 0 (absent) and 3 (severe) each of the items: vocalization, facial expression, body language, physiological modifications, physical modifications; obtaining a score between 0 and 18.
Measured: day 0
Secondary outcomes (5)
Hospital Anxiety Depression Scale (HADS) Questionnaire
This scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to the anxiety dimension (total A) and seven others to the depressive dimension (total D), giving 2 scores. for communicant patients only
Measured: day 0
Algoplus Pain Hetero-Evaluation Scale
This scale searches for elements suggestive of pain in the patient by answering YES/NO to each of the items: face, gaze, complaints, body, and behaviour; score between 0 and 5.
Measured: day 0
Numerical Scale
This is a communicant patient's self-assessment of the intensity of pain felt, between 0 (no pain) and 10 (maximum pain). for communicant patients only
Measured: day 0
Infrared pupillometry measurement
It is an absolute measurement of pupil size using a portable pupillometer
Measured: day 0 before treatment of acute pain
Infrared pupillometry measurement
It is an absolute measurement of pupil size using a portable pupillometer
Measured: day 0 after treatment of acute pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start10 May 2021
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna FERRIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483141
- Sponsor's protocol ID
- RNI 2020 FERRIER
- Other IDs
- 2020-A01360-39
- Acronym
- ABBEY-F
- Status last verified
- May 2021
- First submitted
- 20 Jul 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Abbey Pain Scale in Stroke Patients
- ClinicalTrials.gov ID
- NCT04483141
- Acronym / sponsor ID
- ABBEY-F / RNI 2020 FERRIER
- Keywords
- stroke, pain, aphasia, Abbey pain scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 Jul 2020 (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.
Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event. They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide range of patients have communication problems after stroke that make it difficult to assess pain. Yet there is a major impact of pain on the quality of life of these patients. Some tools have been validated to assess pain in non-communicative patients, but none are specific to stroke patients. The Algoplus scale is commonly used in intra-hospital care in France. The Abbey Pain Scale is not translated into French, and could provide a more accurate pain rating for non-communicative patients.
The objective is to validate a French version of the Abbey Pain Scale for stroke patients.
It is an observational study with longitudinal data collection. It is planned to include 120 patients from the neurology department of the Clermont-Ferrand University Hospital.
Detailed description
The study will be conducted over a 12-month period. 120 patients hospitalized for stroke including 60 communicating and 60 non-communicating patients will be recruited. Epidemiological data will be collected at enrollment, as well as an initial assessment using the Abbey and Algoplus scales for non-communicating and communicating patients, and also the numerical scale for communicating patients. The HADS questionnaire will be completed by communicating patients only. Of the 60 patients in each group, 30 will receive a second concurrent assessment by an inter-rater, 30 will receive a test/retest reassessment after 30 minutes, and 20 will be reassessed 90 minutes later by the same scales after pain treatment. For 30 of the 120 patients, an infrared pupillometry measurement will be performed before and after treatment of acute pain. All patients will be recruited from the neurovascular unit of the Clermont-Ferrand University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-communicant stroke patients | – | Diagnostic Test: Abbey Pain ScalePatients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (hetero-assessment of pain). |
| communicant stroke patients | – | Diagnostic Test: Abbey Pain ScalePatients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (including hetero-assessment and auto-assessment of pain) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke
Key inclusion criteria (5 listed)
- at least 18 years old ;
- Covered by Social Security;
- Hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke;
- NIHSS score greater than 1;
- For communicating patients: French mother tongue, or reading French without assistance, and able to understand the objectives.
Key exclusion criteria (6 listed)
- Refusal ;
- Legally protected patient
- Pregnancy;
- Pre-stroke psychiatric or neurodevelopmental disorders;
- Transient ischemic attack;
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 |
|---|---|---|
| Abbey Pain ScaleHetero-assessment of pain | Diagnostic test | communicant stroke patients, non-communicant stroke patients |
Primary outcome
Abbey Pain Hetero-Evaluation Scale
Time frame: day 0
This scale searches for elements suggestive of pain in the patient by scoring between 0 (absent) and 3 (severe) each of the items: vocalization, facial expression, body language, physiological modifications, physical modifications; obtaining a score between 0 and 18.
5 secondary outcomes
Hospital Anxiety Depression Scale (HADS) Questionnaire
Time frame: day 0
Algoplus Pain Hetero-Evaluation Scale
Time frame: day 0
Numerical Scale
Time frame: day 0
Infrared pupillometry measurement
Time frame: day 0 before treatment of acute pain
Infrared pupillometry measurement
Time frame: day 0 after treatment of acute pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
Anna FERRIER principal investigator
University Hospital, Clermont-Ferrand
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 Stroke and Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 May 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbey Pain Hetero-Evaluation Scale (time frame: day 0). 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 May 2021.