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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Drug: equimolar oxygen-nitrous oxide mixture
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: equimolar oxygen-nitrous oxide mixture<br>equimolar oxygen-nitrous oxide mixture Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture. | Drug: equimolar oxygen-nitrous oxide mixture<br>* Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.<br>|
| Placebo Comparator: Placebo<br>Patients randomized to this arm will have the placebo. | Drug: Placebo<br>* Kinesitherapy is performed with a mask by which patient inhales a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Constant Score using treatment as compared to without treatment. |  | fifteen days of physical therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Pain at visits | 0-100 visual analogue scale (VAS) | At each session: final session on Day 15 | 
| Pain induced during sessions | 0-100 visual analogue scale (VAS) | At each session: final session on Day 15 | 
| Functional improvement | Disabilities of the Arm Shoulder and Hand scale (DASH) | Day 7 | 
| Functional improvement | Disabilities of the Arm Shoulder and Hand scale (DASH) | Day 15 | 
| Functional improvement | Disabilities of the Arm Shoulder and Hand scale (DASH) | Day 45 | 
| Functional improvement | Disabilities of the Arm Shoulder and Hand scale (DASH) | Day 180 | 
| 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 | 
| 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 | 
| Change in the Constant Score using treatment as compared to without treatment |  | Day 7 | 
| Change in the Constant Score using treatment as compared to without treatment |  | Day 45 | 
| Change in the Constant Score using treatment as compared to without treatment |  | Day 180 | 
| Patient Quality of life | Medical Outcome Study Short Form-36 (MOS-SF36) score | Day 1 | 
| Patient Quality of life | MOS-SF36 score | Day 7 | 
| Patient Quality of life | MOS-SF36 score | Day 15 | 
| Patient Quality of life | MOS-SF36 score | Day 45 | 
| Patient Quality of life | MOS-SF36 score | Day 180 | 
| Antalgic intake | Discriptively noted | Until end of study (Day 180) |