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

This study is ongoing, but not recruiting participants.
Sponsor:
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

March 15, 2010
March 29, 2013
March 2010
March 2013   (final data collection date for primary outcome measure)
Change in the Constant Score using treatment as compared to without treatment. [ Time Frame: fifteen days of physical therapy ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01087229 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder
Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Adhesive Capsulitis
Drug: equimolar oxygen-nitrous oxide mixture
Experimental: equimolar oxygen-nitrous oxide mixture
equimolar oxygen-nitrous oxide mixture
Intervention: Drug: equimolar oxygen-nitrous oxide mixture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
August 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01087229
PHRC-I/2008/AD-01, 2008-007161-23
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Arnaud Dupeyron, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP