Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder (MEOPA)
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
equimolar oxygen-nitrous oxide mixture
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis
Eligibility 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
Sites / Locations
- Unité Rééducation Réadaptation Locomotrice
- Centre Hospitalier Universitaire de Nîmes
- CHU de Clermont Ferrand
- CHU Lapeyronie
- Centre Hélio Marin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
equimolar oxygen-nitrous oxide mixture
Placebo
Arm Description
equimolar oxygen-nitrous oxide mixture Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
Patients randomized to this arm will have the placebo.
Outcomes
Primary Outcome Measures
Change in the Constant Score using treatment as compared to without treatment.
Secondary Outcome Measures
Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of active global anterior flexion of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of active global lateral flexion of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of active global abduction of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of active global internal rotation of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of passive global abduction of the shoulder
Range of motion in degrees
Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder
Range of motion in degrees
Pain at visits
0-100 visual analogue scale (VAS)
Pain induced during sessions
0-100 visual analogue scale (VAS)
Functional improvement
Disabilities of the Arm Shoulder and Hand scale (DASH)
Functional improvement
Disabilities of the Arm Shoulder and Hand scale (DASH)
Functional improvement
Disabilities of the Arm Shoulder and Hand scale (DASH)
Functional improvement
Disabilities of the Arm Shoulder and Hand scale (DASH)
Limitations posed to the physiotherapist activity due to patient pain at each session
Likert six-point scale (none, to extremely high)
patient satisfaction
0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions
Change in the Constant Score using treatment as compared to without treatment
Change in the Constant Score using treatment as compared to without treatment
Change in the Constant Score using treatment as compared to without treatment
Patient Quality of life
Medical Outcome Study Short Form-36 (MOS-SF36) score
Patient Quality of life
MOS-SF36 score
Patient Quality of life
MOS-SF36 score
Patient Quality of life
MOS-SF36 score
Patient Quality of life
MOS-SF36 score
Antalgic intake
Discriptively noted
Full Information
NCT ID
NCT01087229
First Posted
March 15, 2010
Last Updated
February 5, 2021
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01087229
Brief Title
Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder
Acronym
MEOPA
Official Title
Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
equimolar oxygen-nitrous oxide mixture
Arm Type
Experimental
Arm Description
equimolar oxygen-nitrous oxide mixture
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to this arm will have the placebo.
Intervention Type
Drug
Intervention Name(s)
equimolar oxygen-nitrous oxide mixture
Intervention Description
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Kinesitherapy is performed with a mask by which patient inhales a placebo.
Primary Outcome Measure Information:
Title
Change in the Constant Score using treatment as compared to without treatment.
Time Frame
fifteen days of physical therapy
Secondary Outcome Measure Information:
Title
Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of active global anterior flexion of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of active global lateral flexion of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of active global abduction of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of active global internal rotation of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of passive global abduction of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder
Description
Range of motion in degrees
Time Frame
Final session on Day 15
Title
Pain at visits
Description
0-100 visual analogue scale (VAS)
Time Frame
At each session: final session on Day 15
Title
Pain induced during sessions
Description
0-100 visual analogue scale (VAS)
Time Frame
At each session: final session on Day 15
Title
Functional improvement
Description
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time Frame
Day 7
Title
Functional improvement
Description
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time Frame
Day 15
Title
Functional improvement
Description
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time Frame
Day 45
Title
Functional improvement
Description
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time Frame
Day 180
Title
Limitations posed to the physiotherapist activity due to patient pain at each session
Description
Likert six-point scale (none, to extremely high)
Time Frame
At each session: final session on Day 15
Title
patient satisfaction
Description
0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions
Time Frame
At each session: final session on Day 15
Title
Change in the Constant Score using treatment as compared to without treatment
Time Frame
Day 7
Title
Change in the Constant Score using treatment as compared to without treatment
Time Frame
Day 45
Title
Change in the Constant Score using treatment as compared to without treatment
Time Frame
Day 180
Title
Patient Quality of life
Description
Medical Outcome Study Short Form-36 (MOS-SF36) score
Time Frame
Day 1
Title
Patient Quality of life
Description
MOS-SF36 score
Time Frame
Day 7
Title
Patient Quality of life
Description
MOS-SF36 score
Time Frame
Day 15
Title
Patient Quality of life
Description
MOS-SF36 score
Time Frame
Day 45
Title
Patient Quality of life
Description
MOS-SF36 score
Time Frame
Day 180
Title
Antalgic intake
Description
Discriptively noted
Time Frame
Until end of study (Day 180)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Dupeyron, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité Rééducation Réadaptation Locomotrice
City
Le Grau du Roi
State/Province
Gard
ZIP/Postal Code
30240
Country
France
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
CHU de Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63118
Country
France
Facility Name
CHU Lapeyronie
City
Montpellier Cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hélio Marin
City
Vallauris
ZIP/Postal Code
06223
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30099150
Citation
Dupeyron A, Denarie M, Richard D, Dobija L, Castelli C, Petiot S, Tavares I, Gelis A, Coudeyre E. Analgesic gas for rehabilitation of frozen shoulder: Protocol for a randomized controlled trial. Ann Phys Rehabil Med. 2019 Jan;62(1):43-48. doi: 10.1016/j.rehab.2018.07.007. Epub 2018 Aug 9.
Results Reference
derived
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Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder
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