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This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).
This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The patients included in the study will be consultants from the Department of Physical Medicine, Rehabilitation and Sports Trauma at Foch Hospital in Suresnes and will have to present chronic pain related to arthritis of the knee either with or without antalgic and anti-inflammatory treatment. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be evaluated by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during each visit and the number of daily antalgic and anti-inflammatory drugs (secondary criteria).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with painful arthritis of the knee | Experimental | Administration of joints and muscle gel Puressentiel containing of 14 essential oils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joint and muscle gel Puressentiel | Device | To evaluate the antalgic effect in patients with chronic pain related to osteoarthritis of the knee when applied to the skin of Puressentiel Joints and Muscles - Gel with 14 essential oils. |
| Measure | Description | Time Frame |
|---|---|---|
| Womac score is the primary outcome | Scoring pain and locomotion with a maximum score (worse of 96). A change of 16 points is considered as a significant clinical improvement | 30 days |
| Pain visual analog analog scale is the secondary outcome | Scoring pain from 1 to 100 (worse) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain visual analog scale | Pain visual analog scale scored from 0 to 100(worse). A change of 10 points is considered as clinically significant | Evaluation at inclusion and after 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Simon, MD | Contact | 33611815878 | n.barizien@hopital-foch.org | |
| Elisabeth Simon | Contact | 0144405528 |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Simon, Pharm Dr | Puressentiel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 9200 | France |
|
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| ID | Term |
|---|---|
| D010146 | Pain |
| D018771 | Arthralgia |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
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open single arm study
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| D009140 | Musculoskeletal Diseases |