Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly

NCT ID: NCT02230007

Last Updated: 2014-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-07-31

Brief Summary

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The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication.

The gas MEOPA administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person.

The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.

Detailed Description

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Conditions

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Pain Management and Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MEOPA

ENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use

Group Type EXPERIMENTAL

MEOPA

Intervention Type DRUG

3 sessions of reeducation using MEOPA

Without MEOPA

Physiotherapit care without MEOPA

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MEOPA

3 sessions of reeducation using MEOPA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 65 years old or more
* Patients having a prescription for physiotherapy
* Absence of contraindication to MEOPA
* Patients whose initial assessment show a passive articular deficit of at least a joint of hip or the knee and whose painful assessment is ≥ 5 or ≥ 2 during mobilisation on the validated scale Algoplus
* Patients whose reeducation project established by the physiotherapist
* Patients having agreed to participate in the study and having signed the consent
* Subjects affiliated to the social security system

Exclusion Criteria

* Patient requiring a ventilation in pure oxygen
* Patient with a consciousness deterioration preventing his cooperation
* Care under MEOPA during the period of the protocol and during the month which precedes
* Increase of the dosage of morphine of less than 48 hours Patient under guardianship
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique Mailland, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Pôle de Gérontologie Hôpital de Cimiez CHU de Nice

Nice, , France

Site Status RECRUITING

CHU de Nice

Nice, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Véronique MAILLAND, MD

Role: CONTACT

0033 4 92034397

Facility Contacts

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Véronique MAILLAND, MD

Role: primary

+33 4 92 03 43 97

Véronique MAILLAND, MD

Role: primary

0033 4 92034397

Other Identifiers

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12AOI02

Identifier Type: OTHER

Identifier Source: secondary_id

2013-000065-37

Identifier Type: -

Identifier Source: org_study_id

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