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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02230007
Other study ID # 2013-000065-37
Secondary ID 12AOI02
Status Recruiting
Phase Phase 4
First received May 7, 2013
Last updated September 2, 2014
Start date June 2013
Est. completion date July 2015

Study information

Verified date December 2013
Source Centre Hospitalier Universitaire de Nice
Contact Véronique MAILLAND, MD
Phone 0033 4 92034397
Email mailland-putegnat@chu-nice.fr
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: The Commission nationale de l’informatique et des libertés
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date July 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
MEOPA
3 sessions of reeducation using MEOPA

Locations

Country Name City State
France CHU de Nice Nice
France Pôle de Gérontologie Hôpital de Cimiez CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary % 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 Yes
Secondary Measure of the pain Patient answer a questionnaire on his pain at the beginning of each session of reeducation (5 sessions) 5 days No
Secondary 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) No
Secondary 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) No
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