Care-related Pain and Discomfort in People With Motor Disorder

• Conditions: Motor Disorders; Pain

• Registration Number: NCT02720731
• Lead Sponsor: University Hospital, Brest

Brief Summary

The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-28
• Study Start: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• motor disorder
• institutionalized

Exclusion Criteria

• chronical pain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale	5 days

Secondary Outcome Measures

Name	Time	Method
Pain related to care-activities assessed with the Visual Analog Scale (VAS).	5 days

Trial Locations

Locations (10)

Centre Creac'h Ar Roual; 🇫🇷 Dirinon, France

IME section polyhandicapes Kerlaouen; 🇫🇷 Guipavas, France

SEAPH-IME Kerveguen; 🇫🇷 Plabennec, France

IEM Plerin; 🇫🇷 Plerin cedex, France

IEM Ar Men; 🇫🇷 Ploemeur, France

Centre de Rééducation fonctionnelle de Kerpape; 🇫🇷 Ploemeur, France

CHRU de Rennes; 🇫🇷 Rennes, France

Fondation Ildys site de Perhardy; 🇫🇷 Roscoff Cedex, France

Centre Rééducation Trestel; 🇫🇷 Trevou Treguignec, France

EEAP Maison de L'estran; 🇫🇷 Trevou Treguignec, France