The required study population was patients affected by gonarthrosis Musculoskeletal Diseases Gonarthrosis (arthrosis of knee)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women >25 and 2 on the Lequesne pain-function index (LI). The LI is a disease-specific validated questionnaire that poses a series of questions about pain in the knee (five questions on a scale from 0 to 2, where 0 indicates no pain and 2 intense pain), functional limitation (four questions, using the same scale) and maximum walking distance (one question, with a score from 0 to 6, where 0 indicates the ability to walk for an unlimited distance and 6, the inability to cover 100 m). The maximum worst ?nal score is 24. Lack of symptoms in other joints was not taken into consideration.
Exclusion criteria
Exclusion criteria: 1. Previous surgery of the affected knee 2. Disease processes such as rheumatoid arthritis, autoimmune diseases, systemic diseases, and tumors 3. Severe obesity (BMI >40 kg/m2) 4. Allergy to shellfish 5. Altered blood chemistry and kidney, liver, and metabolic (diabetes mellitus) function; 6. Intra-articular hyaluronic acid/cortisone infiltrations to the affected knee within 3 months before the start of the study 7. Systemic cortisone treatment taken within 3 months before the start of the study 8. Supplements (glucosamine, chondroitin sulfate, bromeline, etc) taken within 3 months before the start of the study (patients were also informed that they were not to be taken for the following 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment, de?ned as a decrease of pain on the VAS and an improvement in the patient’s global assessment score on the LEQUESNE INDEX from baseline at 2 and at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the patients’ need to take anti-inflammatory drugs at 2 and 6 months. All analyses were performed at each FU, comparing results within each group and between the two groups. | — |
Countries
Italy