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

Adhesive Capsulitis Clinical Trial

— MEOPA  

Official title:

Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087229
• Other study ID #: PHRC-I/2008/AD-01
• Secondary ID: 2008-007161-23
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: September 2013

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• equimolar oxygen-nitrous oxide mixture
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
• Placebo
Kinesitherapy is performed with a mask by which patient inhales a placebo.

Locations

Country	Name	City	State
France	CHU de Clermont Ferrand	Clermont-Ferrand
France	Unité Rééducation Réadaptation Locomotrice	Le Grau du Roi	Gard
France	CHU Lapeyronie	Montpellier Cedex 05
France	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard
France	Centre Hélio Marin	Vallauris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Constant Score using treatment as compared to without treatment.		fifteen days of physical therapy
Secondary	Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of active global anterior flexion of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of active global lateral flexion of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of active global abduction of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of active global internal rotation of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of passive global abduction of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder	Range of motion in degrees	Final session on Day 15
Secondary	Pain at visits	0-100 visual analogue scale (VAS)	At each session: final session on Day 15
Secondary	Pain induced during sessions	0-100 visual analogue scale (VAS)	At each session: final session on Day 15
Secondary	Functional improvement	Disabilities of the Arm Shoulder and Hand scale (DASH)	Day 7
Secondary	Functional improvement	Disabilities of the Arm Shoulder and Hand scale (DASH)	Day 15
Secondary	Functional improvement	Disabilities of the Arm Shoulder and Hand scale (DASH)	Day 45
Secondary	Functional improvement	Disabilities of the Arm Shoulder and Hand scale (DASH)	Day 180
Secondary	Limitations posed to the physiotherapist activity due to patient pain at each session	Likert six-point scale (none, to extremely high)	At each session: final session on Day 15
Secondary	patient satisfaction	0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions	At each session: final session on Day 15
Secondary	Change in the Constant Score using treatment as compared to without treatment		Day 7
Secondary	Change in the Constant Score using treatment as compared to without treatment		Day 45
Secondary	Change in the Constant Score using treatment as compared to without treatment		Day 180
Secondary	Patient Quality of life	Medical Outcome Study Short Form-36 (MOS-SF36) score	Day 1
Secondary	Patient Quality of life	MOS-SF36 score	Day 7
Secondary	Patient Quality of life	MOS-SF36 score	Day 15
Secondary	Patient Quality of life	MOS-SF36 score	Day 45
Secondary	Patient Quality of life	MOS-SF36 score	Day 180
Secondary	Antalgic intake	Discriptively noted	Until end of study (Day 180)