equimolar oxygen-nitrous oxide mixture
DrugKinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
NCT Number: NCT01087229
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Unité Rééducation Réadaptation Locomotrice, Le Grau-du-Roi, Gard, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
Kinesitherapy is performed with a mask by which patient inhales a placebo.
Time frame: fifteen days of physical therapy
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: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: Final session on Day 15
Range of motion in degrees
Time frame: At each session: final session on Day 15
0-100 visual analogue scale (VAS)
Time frame: At each session: final session on Day 15
0-100 visual analogue scale (VAS)
Time frame: Day 7
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time frame: Day 15
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time frame: Day 45
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time frame: Day 180
Disabilities of the Arm Shoulder and Hand scale (DASH)
Time frame: At each session: final session on Day 15
Likert six-point scale (none, to extremely high)
Time frame: At each session: final session on Day 15
0-10 VAS: 10=session interrupted due to pain; 0= session completed under perfect conditions
Time frame: Day 7
Time frame: Day 45
Time frame: Day 180
Time frame: Day 1
Medical Outcome Study Short Form-36 (MOS-SF36) score
Time frame: Day 7
MOS-SF36 score
Time frame: Day 15
MOS-SF36 score
Time frame: Day 45
MOS-SF36 score
Time frame: Day 180
MOS-SF36 score
Time frame: Until end of study (Day 180)
Discriptively noted
Centre Hospitalier Universitaire de Nīmes
Other
Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis
Acronym: MEOPA
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