Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

Not Applicable

Completed

• Conditions: Pain Threshold; Multiple System Atrophy
• Interventions: Drug: Levodopa test; Procedure: determination of objective and subjective pain threshold

• Registration Number: NCT01577992
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype) or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it ended with the patient's death few years later. No neuroprotective treatment has shown a real efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication of dopamine neuromediator pathway in integration and modulation of pain. Several studies suggest the existence of various influences with dopamine implication in the appearance of painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA and PD could be due to a decrease of pain appearance threshold, secondary to a lost of control of sensitizes centres, to Parkinson control.

It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold and to characterise the levodopa effect on the patient's pain threshold. Better physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care. Because the efficacy of others treatments is low, it's important to improve the research for a better comfort of patients with a better understanding, analysing and treating of the pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-07
• Study Start: 2011-12
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-16
• Primary Completion: 2013-06
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients from 50 to 80 years old (Male and female)
• Patients suffering of a diagnosis possible or probable MSA-P with the international criteria (2008).
• Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB (Gibb et Lees, 1988; Hughes et al, 1992)
• Patients with no cognitive troubles
• Patients who give their informed and signed consent.
• Patients affiliated to a social protection program

Exclusion Criteria

• Patient suffering from an other parkinson syndrome than MSA and PD, by example progressive supranuclear palsy, corticobasal degeneration...
• Patient suffering of a diagnosis possible or probable MSA-C with the international criteria
• Patient suffering from another pathology causing chronic pain (rheumatic disease, traumatic or orthopedic pathologies...)
• Patient under tutelage, curatella or law protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: MSA disease	Levodopa test	determination of objective and subjective pain threshold before and after levodopa intake
Group 2: Parkinson disease	Levodopa test	determination of objective and subjective pain threshold before and after levodopa intake
Group 3: healthy volunteers.	determination of objective and subjective pain threshold	one determination of objective and subjective pain threshold without treatment

Primary Outcome Measures

Name	Time	Method
Subjective pain threshold	60 minutes	Subjective pain threshold determined using thermal stimulation (Thermotest) with the method of levels, before and after levodopa intake for MSA patients and PD patients and once for healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Objective nociceptive pain threshold	15 minutes	Objective nociceptive pain threshold thanks to reflex of flexion (reflex RIII)before and after levodopa intake for MSA patients and PD patients and once for healthy volunteers

Trial Locations

Locations (1)

University Hospital, neurology; 🇫🇷 Toulouse, France