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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Joint Pain
• Intervention / Treatment: Device: Joint and muscle gel Puressentiel

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Simon, MD; Phone Number: 33611815878; Email: n.barizien@hopital-foch.org
• Study Contact Backup: Name: Elisabeth Simon; Phone Number: 0144405528

Study Locations

• France
  • Suresnes, France, 9200
    • Hopital Foch
    • Contact: Nicolas Barizien, MD; Phone Number: 0611815878

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with painful arthritis of the knee; Administration of joints and muscle gel Puressentiel containing of 14 essential oils	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Marco Pacchioni
• Investigators: Study Director: Elisabeth Simon, Pharm Dr, Puressentiel

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Arthritis; Pain; Knee
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: Puressentiel laboratory

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No