Pain in Adults With Autism Spectrum Disorder

Not Applicable

Terminated

• Conditions: Autism; Pain
• Interventions: Device: thermode

• Registration Number: NCT02277756
• Lead Sponsor: University Hospital, Brest

Brief Summary

Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

Detailed Description

Adults with autism without intellectual disability (IQ \> 85) are matched with members of siblings and control group (sex and chronological age).

Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test.

Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).

Study Timeline

• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Study Start: 2015-05-29
• Primary Completion: 2017-04-05
• Study Completion: 2017-04-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

• chronic pain
• pregnancy, breast feeding
• consent form no signed

Exclusion criteria sibling and witness groups:

• diagnosis of autism or developmental disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high functioning Autism	thermode	Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with high functioning Autism
witness	thermode	Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness

Primary Outcome Measures

Name	Time	Method
Pain as assessed by Computerized Visual analog scale	one day

Secondary Outcome Measures

Name	Time	Method
salivary cortisol	one day
Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale	one day
heart rate variability	one day

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France