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Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder (MEOPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087229
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Drug: equimolar oxygen-nitrous oxide mixture Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: equimolar oxygen-nitrous oxide mixture

equimolar oxygen-nitrous oxide mixture

Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.

 Drug: equimolar oxygen-nitrous oxide mixture
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
Placebo Comparator: Placebo
Patients randomized to this arm will have the placebo.
 Drug: Placebo
Kinesitherapy is performed with a mask by which patient inhales a placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Constant Score using treatment as compared to without treatment. [ Time Frame: fifteen days of physical therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087229


Locations
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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
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Principal Investigator: Arnaud Dupeyron, MD Centre Hospitalier Universitaire de Nîmes
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01087229    
Other Study ID Numbers: PHRC-I/2008/AD-01
2008-007161-23 ( EudraCT Number )
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents