Gonarthrosis
Conditions
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).
Interventions
DIETARY_SUPPLEMENTCartimotil Fort
1 to 4 capsules per day during 90 days
Sponsors
PiLeJe
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients reaching the acceptability threshold of their state | day 30 | Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable). |
Secondary
| Measure | Time frame |
|---|---|
| OASIS Score | Day 30 |
| Yes answer for the PASS | Day 60 |
Countries
France
Outcome results
None listed