Clinical trial NCT04483141: Translation and Validation of the Abbey Pain Scale in Stroke Patients (ABBEY-F)
Official title: Translation and Validation of the Abbey Pain Scale in Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Pain
Keywords: stroke
pain
aphasia
Abbey pain scale
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Refusal ;
* Legally protected patient
* Pregnancy;
* Pre-stroke psychiatric or neurodevelopmental disorders;
* Transient ischemic attack;
* Specific strokes: Bithalamic, locked-in syndrome.

Primary outcomes:
measure: Abbey Pain Hetero-Evaluation Scale
timeFrame: day 0
Secondary outcomes:
measure: Hospital Anxiety Depression Scale (HADS) Questionnaire
timeFrame: day 0
measure: Algoplus Pain Hetero-Evaluation Scale
timeFrame: day 0
measure: Numerical Scale
timeFrame: day 0
measure: Infrared pupillometry measurement
timeFrame: day 0 before treatment of acute pain
measure: Infrared pupillometry measurement
timeFrame: day 0 after treatment of acute pain
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Anna FERRIER
role: PRINCIPAL_INVESTIGATOR
References: