Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder (MEOPA)
This study is ongoing, but not recruiting participants.
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01087229
First received: March 15, 2010
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine whether or not the use of an equimolar mixture of oxygen and nitrous oxide during the physical therapy for patients suffering from frozen shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant Score) and less pain as compared to patients undergoing physical therapy without this treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Adhesive Capsulitis |
Drug: equimolar oxygen-nitrous oxide mixture |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis |
Resource links provided by NLM:
MedlinePlus related topics:
Oxygen Therapy
Drug Information available for:
Nitrous oxide
U.S. FDA Resources
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- Change in the Constant Score using treatment as compared to without treatment. [ Time Frame: fifteen days of physical therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: equimolar oxygen-nitrous oxide mixture
equimolar oxygen-nitrous oxide mixture
|
Drug: equimolar oxygen-nitrous oxide mixture |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Affiliated with a social security system
- Has signed the consent form
- Patient has a painful, or initially painful but stable frozen shoulder (adhesive capsulitis): stiffening characterized by a passive loss of amplitude on three planes. This loss of amplitude is greater than or equal to 50% of controlateral amplitude when the controlateral shoulder is considered as normal. Otherwise, the loss of amplitude is greater than or equal to 50% of normal anatomical values.
- Radiography confirms the integrity of the glenohumeral interspace.
Exclusion Criteria:
- Intercurrent, evolving or unstable pathology: cancer, advanced cardio-vascular pathology, severe infection
- The patient is taking a treatment that may interfere with the study (eg corticoids, pain killers, chemotherapy)
- Contra-indication for physical therapy
- Coagulopathy
- Advanced diabetes mellitus, with neurological or joint complications
- Contra indication for the experimental treatment
- Pregnant or nursing women
- Patient's mental state prevents him/her from understanding the nature of the study, its objectives and potential consequences.
- Patient under guardianship
- Patient is in an exclusion period determined by a previous study
- Patient not able to follow protocol constraints or timetable
- Medical history of local infection, polyarthritis or neuropathy that might explain the shoulder pain.
- Absence of radiculopathy of cervical origin, of rotator cuff tears or evolving shoulder tendinopathy, of severe omarthrose
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087229
Locations
| France | |
| Unité Rééducation Réadaptation Locomotrice | |
| Le Grau du Roi, Gard, France, 30240 | |
| Centre Hospitalier Universitaire de Nîmes | |
| Nîmes, Gard, France, 30029 | |
| CHU de Clermont Ferrand | |
| Cébézat, France, 63118 | |
| CHU Lapeyronie | |
| Montpellier Cedex 05, France, 34295 | |
| Centre Hélio Marin | |
| Vallauris, France, 06223 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Arnaud Dupeyron, MD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01087229 History of Changes |
| Other Study ID Numbers: | PHRC-I/2008/AD-01, 2008-007161-23 |
| Study First Received: | March 15, 2010 |
| Last Updated: | March 29, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Additional relevant MeSH terms:
|
Bursitis Joint Diseases Musculoskeletal Diseases Nitrous Oxide Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013