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

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.

Study Overview

• Status: Unknown
• Conditions: Pain Management and Care
• Intervention / Treatment: Drug: MEOPA

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Véronique MAILLAND, MD; Phone Number: 0033 4 92034397; Email: mailland-putegnat@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Pôle de Gérontologie Hôpital de Cimiez CHU de Nice
    • Contact: Véronique MAILLAND, MD; Phone Number: +33 4 92 03 43 97; Email: mailland-putegnat.v@chu-nice.fr
    • Principal Investigator: Véronique MAILLAND, MD
  • Nice, France, 06003
    • Not yet recruiting
    • Chu de Nice
    • Contact: Véronique MAILLAND, MD; Phone Number: 0033 4 92034397; Email: mailland-putegnat@chu-nice.fr
    • Principal Investigator: Véronique MAILLAND, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEOPA; ENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use	Drug: MEOPA; 3 sessions of reeducation using MEOPA
No Intervention: Without MEOPA; Physiotherapit care without MEOPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of recovery of the hip and knee joint articular amplitude	% of recovery of the hip and knee joint articular amplitude during 5 days after 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment; measure % of recovery of the hip and knee joint articular amplitude two times : before the beginning of the session of reeducation and at the end of the session	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the pain	Patient answer a questionnaire on his pain at the beginning of each session of reeducation (5 sessions)	5 days
Patients'satisfaction	Patient answer a questionnaire on this satisfaction at the end of the period of care of the protocol.	End of the period of care (up to 5 days)
Physiotherapists'satisfaction	Physiotherapists answer a questionnaire on this satisfaction of the use of the MEOPA	End of all the period of care (up to 5 days)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Véronique Mailland, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: September 2, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 2013-000065-37; 12AOI02 (Other Identifier: CHU DE NICE)