Translation and Validation of the Abbey Pain Scale in Stroke Patients (ABBEY-F)

Last updated: May 10, 2021
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Pain

Treatment

N/A

Clinical Study ID

NCT04483141
RNI 2020 FERRIER
2020-A01360-39
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • at least 18 years old ;
  • Covered by Social Security;
  • Hospitalized in the Neurovascular Unit for the management of ischemic stroke with orwithout reperfusion treatment, or hemorrhagic stroke;
  • NIHSS score greater than 1;
  • For communicating patients: French mother tongue, or reading French withoutassistance, and able to understand the objectives.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 120
Study Start date:
May 10, 2021
Estimated Completion Date:
June 30, 2022

Study 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.

Connect with a study center

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

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