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

NCT04736563 | Unknown

• 1 other identifier: Puressentiel laboratory
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Joint Pain

Keywords

Pain; Arthritis; Knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain visual analog scale

  Evaluation at inclusion and after 30 days

Study Arms (1)

patients with painful arthritis of the knee

EXPERIMENTAL

Administration of joints and muscle gel Puressentiel containing of 14 essential oils

Device: Joint and muscle gel Puressentiel

Interventions

Joint and muscle gel Puressentiel DEVICE

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.

patients with painful arthritis of the knee

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marco Pacchioni: lead

Study Sites (1)

Hopital Foch

Suresnes, 9200, France

Location

MeSH Terms

Conditions

Pain; Arthralgia; Arthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Elisabeth Simon, Pharm Dr

  Puressentiel

  STUDY DIRECTOR

Central Study Contacts

Elisabeth Simon, MD

CONTACT

33611815878; n.barizien@hopital-foch.org

Elisabeth Simon

CONTACT

0144405528

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President Puressentiel laboratory

Model Details: open single arm study

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: February 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

FR (1)