Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.

NCT ID: NCT02977936

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-12
• Study Completion Date: 2019-09-05

Brief Summary

The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.

Detailed Description

For this study, 126 patients are going to be included. They will have a supplementation of Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.

on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (DN4).

on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).

Conditions

Gonarthrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cartimotil Fort

1 to 4 capsules per day during 90 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• VAS of pain : minimum 5/10 on walking or 4/10 at rest
• Patients with a negative PASS (patient considering that the symptomatic state is not acceptable)
• Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen scale - clinical examination)
• Having agreed to participate in the investigation after receiving information from the investigator

Exclusion Criteria

• Patients with rheumatological disorders other than osteoarthritis
• Patients for whom knee surgery is planned within 3 months
• Patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month
• Patients with a BMI greater than 35
• Patients with chronic pain that can interfere with knee osteoarthritis pain
• Patients with reduced mobility or bedridden
• Patients with cognitive impairments not able to participate in the study
• Patients with known allergies to any of the ingredients of Cartimotil Fort®
• Pregnant or breastfeeding patients
• Patients who do not wish to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pileje Network of medical practitioners in private offices

Paris, , France

Countries

France

References

Perrot S, Trouvin AP, Bouhassira D. Three dimensions of pain in osteoarthritis: development and validation of the Osteoarthritis Symptom Inventory Scale. Pain. 2023 Jul 1;164(7):1566-1577. doi: 10.1097/j.pain.0000000000002856. Epub 2023 Mar 22.

Reference Type: DERIVED

PMID: 36602324 (View on PubMed)

Other Identifiers

PiL-Obs-CFort-016

Identifier Type: -

Identifier Source: org_study_id