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

Centre Hospitalier Universitaire de Nīmes75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Adhesive Capsulitis

Interventions

equimolar oxygen-nitrous oxide mixtureDRUG

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

PlaceboDRUG

Kinesitherapy is performed with a mask by which patient inhales a placebo.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Unité Rééducation Réadaptation Locomotrice

Le Grau-du-Roi, Gard, France

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

CHU de Clermont Ferrand

Clermont-Ferrand, France

CHU Lapeyronie

Montpellier, France

Outcomes

Primary Outcomes

Change in the Constant Score using treatment as compared to without treatment.

The Constant score questionnaire consists of 11 questions that result in a final score ranging from 0 to 100. The higher the test result, the more normally the shoulder is functioning.

Time frame: fifteen days of physical therapy