Pain Management and CarePhase 4NCT02230007
Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly
A Phase 4 study testing MEOPA in people with Pain Management and Care, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain Management and Care
- What is being tested?
- MEOPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Sep 2013to 24 Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pôle de Gérontologie Hôpital de Cimiez CHU de Nice
Nice, 06000
CHU de Nice
Nice
About this study
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.
- Conditions
- Pain Management and Care
- Being tested
- MEOPA
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEOPADrug
3 sessions of reeducation using MEOPA
| Study group | Role | What they receive |
|---|---|---|
| MEOPA | Experimental | ENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use Receives: Drug: MEOPA |
| Without MEOPA | No intervention | Physiotherapit care without MEOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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
Measured: 5 days
Secondary outcomes (3)
Measure of the pain
Patient answer a questionnaire on his pain at the beginning of each session of reeducation (5 sessions)
Measured: 5 days
Patients'satisfaction
Patient answer a questionnaire on this satisfaction at the end of the period of care of the protocol.
Measured: 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
Measured: End of all the period of care (up to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start18 Sep 2013
- Primary completion17 Feb 2015
- Study completion24 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management and CareStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Mailland, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230007
- Sponsor's protocol ID
- 2013-000065-37
- Other IDs
- 12AOI02
- Status last verified
- Jun 2026
- First submitted
- 7 May 2013
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly
- ClinicalTrials.gov ID
- NCT02230007
- Acronym / sponsor ID
- 2013-000065-37
- Conditions
- Pain Management and Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Sep 2013 (actual)
- Primary completion
- 17 Feb 2015 (actual)
- Study completion
- 24 Feb 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEOPA | Experimental | Drug: MEOPAENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use |
| Without MEOPA | No intervention | –Physiotherapit care without MEOPA |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEOPA3 sessions of reeducation using MEOPA | Drug | MEOPA |
Primary outcome
% of recovery of the hip and knee joint articular amplitude
Time frame: 5 days
% 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
3 secondary outcomes
Measure of the pain
Time frame: 5 days
Patients'satisfaction
Time frame: End of the period of care (up to 5 days)
Physiotherapists'satisfaction
Time frame: End of all the period of care (up to 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Mailland, MD principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MEOPA in people with Pain Management and Care, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of recovery of the hip and knee joint articular amplitude (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.