Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee

Pain Clinical Trial

— EVAPURGEL  

Official title:

Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04736563
• Other study ID #: Puressentiel laboratory
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2021
• Source: Puressentiel
• Contact: Elisabeth Simon, MD
• Phone: 33611815878
• Email: n.barizien[@]hopital-foch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthralgia
• Joint Pain
• Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Marco Pacchioni

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain visual analog analog scale is the secondary outcome	Scoring pain from 1 to 100 (worse)	30 days
Secondary	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