Clinical trial NCT04736563: Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee
Official title: Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Joint Pain
Keywords: Pain
Arthritis
Knee
Lead sponsor: Puressentiel
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open single arm study
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Womac score is the primary outcome
timeFrame: 30 days
measure: Pain visual analog analog scale is the secondary outcome
timeFrame: 30 days
Secondary outcomes:
measure: Pain visual analog scale
timeFrame: Evaluation at inclusion and after 30 days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Puressentiel
name: Elisabeth Simon, Pharm Dr
role: STUDY_DIRECTOR
References: