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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02333-36 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis
Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a monocentric prospective controlled randomised, single-blind study. Patients with acute and painful knee osteoarthritis, having an indication of lavage according to the rheumatologist, will be randomized to standard care, versus standard care and hypnosis. The hypothesis is that hypnosis intervention will decrease the level of pain during lavage, and the analgesics consumption during the week following the lavage. The sample size will be 100, 50 patients per group. Inclusion is scheduled for 18 months, and duration of the study will be 2 years. The main efficacy criterion is the pain score (assessed using VAS) difference between the 2groups; no interim analysis will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | No Intervention | Standard care | |
| Hypnosis | Active Comparator | Standard care + intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Other | given by Expert in this method |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe pain | One Day, at end of lavage procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe anxiety | Day 1, before lavage procedure |
| Anxiety assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna MOLTO, MD, PhD | APHP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital - Rheumatology department | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Day 1, at end of lavage procedure |
| Pain assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe pain | Day 1, before lavage procedure |
| Pain assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe pain -via phone call | Day 7, after lavage procedure |
| Gesture tolerability | 4 points : Perfectly tolerable / tolerable / with difficulty / untolerable | Day 1, at end of lavage procedure |
| Analgesics consumption | Quantification | Over 1 week after lavage procedure |
| Operator Impact | pain VAS by linear regression, adjusted by the 'operator' variable | Over 1 week after lavage procedure |
| D012216 |
| Rheumatic Diseases |
| D004191 |
| Behavioral Disciplines and Activities |