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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01087229
First received: March 15, 2010
Last updated: March 3, 2014
Last verified: March 2014
  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
Drug: Placebo
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:


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 ]

Enrollment: 75
Study Start Date: March 2010
Study Completion Date: September 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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 3, 2014
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:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014