Back to resultsEvaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee (EVAPURGEL)
Primary Purpose
Pain, Joint Pain
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Joint and muscle gel Puressentiel
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Arthritis, Knee
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.
Sites / Locations
- Hopital Foch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with painful arthritis of the knee
Arm Description
Administration of joints and muscle gel Puressentiel containing of 14 essential oils
Outcomes
Primary Outcome Measures
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
Pain visual analog analog scale is the secondary outcome
Scoring pain from 1 to 100 (worse)
Secondary Outcome Measures
Pain visual analog scale
Pain visual analog scale scored from 0 to 100(worse). A change of 10 points is considered as clinically significant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04736563
Brief Title
Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee
Acronym
EVAPURGEL
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Pacchioni
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Joint Pain
Keywords
Pain, Arthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with painful arthritis of the knee
Arm Type
Experimental
Arm Description
Administration of joints and muscle gel Puressentiel containing of 14 essential oils
Intervention Type
Device
Intervention Name(s)
Joint and muscle gel Puressentiel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Womac score is the primary outcome
Description
Scoring pain and locomotion with a maximum score (worse of 96). A change of 16 points is considered as a significant clinical improvement
Time Frame
30 days
Title
Pain visual analog analog scale is the secondary outcome
Description
Scoring pain from 1 to 100 (worse)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pain visual analog scale
Description
Pain visual analog scale scored from 0 to 100(worse). A change of 10 points is considered as clinically significant
Time Frame
Evaluation at inclusion and after 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Simon, MD
Phone
33611815878
Email
n.barizien@hopital-foch.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Simon
Phone
0144405528
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Simon, Pharm Dr
Organizational Affiliation
Puressentiel
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
9200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Barizien, MD
Phone
0611815878
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel on Joint Pain of the Knee
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