Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-06-30

Brief Summary

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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).

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Detailed Description

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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 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).

Conditions

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Pain Joint Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open single arm study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with painful arthritis of the knee

Administration of joints and muscle gel Puressentiel containing of 14 essential oils

Group Type EXPERIMENTAL

Joint and muscle gel Puressentiel

Intervention Type 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.

Interventions

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Joint and muscle gel Puressentiel

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject smust be able to understand the terms of the written informed consent and must agree to date and sign it before any study procedure is carried out,
* Patient having signed the informed consent
* Aged 45 to 90
* With chronic osteoarthritis of the knee
* Patient with or without analgesic and anti-inflammatory treatment

Exclusion Criteria

* Patient at the stage of surgical osteoarthritis (grade 4 plus limitation of amplitude)
* Patient with a limited walking perimeter (\<100m) for any reason whatsoever
* Patient allergic to one of the components of the study product
* Patient not benefiting from social security
* Patient cannot be followed for the duration of the study
* Participation in another clinical trial within 30 days before V0
* Subjects who cannot understand or perform study procedures.
* Pregnant or breastfeeding women
* People with a history of convulsive or epileptic disorders
* People allergic to salicylates.

Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No