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

P

Puressentiel

Status

Unknown

Conditions

Joint Pain
Pain

Treatments

Device: Joint and muscle gel Puressentiel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04736563
Puressentiel laboratory

Details and patient eligibility

About

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).

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

45 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

patients with painful arthritis of the knee
Experimental group
Description:
Administration of joints and muscle gel Puressentiel containing of 14 essential oils
Treatment:
Device: Joint and muscle gel Puressentiel

Trial contacts and locations

1

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Central trial contact

Elisabeth Simon; Elisabeth Simon, MD

Data sourced from clinicaltrials.gov

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