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

Phase 4

Completed

• Conditions: Adhesive Capsulitis
• Interventions: Drug: Placebo; Drug: equimolar oxygen-nitrous oxide mixture

• Registration Number: NCT01087229
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2013-03
• Study Completion: 2013-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients randomized to this arm will have the placebo.
equimolar oxygen-nitrous oxide mixture	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.

Primary Outcome Measures

Name	Time	Method
Change in the Constant Score using treatment as compared to without treatment.	fifteen days of physical therapy

Secondary Outcome Measures

Name	Time	Method
Change in kinetics at final session since baseline of active global abduction of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder	Final session on Day 15	Range of motion in degrees
Functional improvement	Day 180	Disabilities of the Arm Shoulder and Hand scale (DASH)
Pain at visits	At each session: final session on Day 15	0-100 visual analogue scale (VAS)
Pain induced during sessions	At each session: final session on Day 15	0-100 visual analogue scale (VAS)
Change in kinetics at final session since baseline of active global lateral flexion of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of active global internal rotation of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder	Final session on Day 15	Range of motion in degrees
Change in kinetics at final session since baseline of active global anterior flexion of the shoulder	Final session on Day 15	Range of motion in degrees
patient satisfaction	At each session: final session on Day 15	0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions
Change in kinetics at final session since baseline of passive global abduction of the shoulder	Final session on Day 15	Range of motion in degrees
Change in the Constant Score using treatment as compared to without treatment	Day 180
Patient Quality of life	Day 180	MOS-SF36 score
Antalgic intake	Until end of study (Day 180)	Discriptively noted
Limitations posed to the physiotherapist activity due to patient pain at each session	At each session: final session on Day 15	Likert six-point scale (none, to extremely high)

Trial Locations

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 Cedex 05, France

Centre Hélio Marin; 🇫🇷 Vallauris, France