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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007161-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| equimolar oxygen-nitrous oxide mixture | Experimental | equimolar oxygen-nitrous oxide mixture Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture. |
|
| Placebo | Placebo Comparator | Patients randomized to this arm will have the placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| equimolar oxygen-nitrous oxide mixture | Drug | Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Constant Score using treatment as compared to without treatment. | 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. | fifteen days of physical therapy |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Dupeyron, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité Rééducation Réadaptation Locomotrice | Le Grau-du-Roi | Gard | 30240 | France | ||
| Centre Hospitalier Universitaire de Nîmes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38118247 | Result | Dupeyron A, Dobija L, Castelli C, Petiot S, Tavares I, Gelis A, Coudeyre E. Nitrous oxide provided during intensive physiotherapy for shoulder adhesive capsulitis does not improve function: A randomised controlled trial. Ann Phys Rehabil Med. 2024 Apr;67(3):101803. doi: 10.1016/j.rehab.2023.101803. Epub 2023 Dec 19. | |
| 30099150 | Derived |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Drug | Kinesitherapy is performed with a mask by which patient inhales a placebo. |
|
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) |
| Nîmes |
| Gard |
| 30029 |
| France |
| CHU de Clermont Ferrand | Clermont-Ferrand | 63118 | France |
| CHU Lapeyronie | Montpellier | 34295 | France |
| Centre Hélio Marin | Vallauris | 06223 | France |
| 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. |