CClinicalTrials.gg
Status unknownNCT04736563EVAPURGELUpdated Feb 10, 2021

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

An interventional study of Joint and muscle gel Puressentiel in Pain and Joint Pain, sponsored by Marco Pacchioni. Status unknown at 1 site in France. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Marco Pacchioni · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
45 Years to 90 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Pain
  • Joint Pain

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Keywords

  • Pain
  • Arthritis
  • Knee
03

In context

Arthralgia

273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.

This study's planned enrollment of 40 is below the median of 63 across 219 interventional studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

This is the only study on the registry with Marco Pacchioni as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceJoint 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

  2. Pain visual analog analog scale is the secondary outcome

    Scoring pain from 1 to 100 (worse)

    Time frame: 30 days

Secondary outcomes

  1. Pain visual analog scale

    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

07

Study locations

1 site
  • Hopital Foch
    Suresnes, 9200, France
    • Nicolas Barizien, MD · Contact · 0611815878
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04736563
Lead sponsor
Marco Pacchioni
Responsible party
Marco Pacchioni (President Puressentiel laboratory, Puressentiel) — Sponsor-investigator
First posted
Feb 3, 2021
Start date
Feb 1, 2021 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Feb 10, 2021

Study contacts

Elisabeth Simon, MD
Contact
n.barizien@hopital-foch.org
33611815878
Elisabeth Simon
Contact
0144405528
Elisabeth Simon, Pharm Dr
study director · Puressentiel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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