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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 15, 2010 | ||||
| Last Updated Date | March 29, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in the Constant Score using treatment as compared to without treatment. [ Time Frame: fifteen days of physical therapy ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Change in the Constant Score using treatment as compared to without treatment. [ Time Frame: j15 (fifteen days of physical therapy) ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01087229 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder | ||||
| Official Title ICMJE | Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Adhesive Capsulitis | ||||
| Intervention ICMJE | Drug: equimolar oxygen-nitrous oxide mixture | ||||
| Study Arm (s) | Experimental: equimolar oxygen-nitrous oxide mixture
equimolar oxygen-nitrous oxide mixture
Intervention: Drug: equimolar oxygen-nitrous oxide mixture |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | August 2013 | ||||
| Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01087229 | ||||
| Other Study ID Numbers ICMJE | PHRC-I/2008/AD-01, 2008-007161-23 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nīmes | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nīmes | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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