Comparative Effectiveness of Methylsulfonylmethane and Boswellic Acids versus Glucosamine Sulfate in the Treatment of Mild to Moderate Knee Arthritis

aborest Spa0 个研究点目标入组 200 人开始时间: 2015年2月4日最近更新: 2015年7月6日

适应症

试验速览

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•1. Men and women >25 and <86 years of age
•2. A diagnosis of OA of the knee according to the criteria of the American College of Rheumatology
•3. Grade 3 Kellgren and Lawrence radiographic staging, in which the severity of the arthritis is assessed on a scale from 0-4, hypothesizing a sequential evolution from the manifestation of osteophytes through a reduction in the width of the joint space, to subchondral sclerosis and ?nally the formation of cysts
•4. Frequent joint pain (several days a week) for at least 6 months before recruitment;
•5. Pain in the knee, scored at least 2 cm on a 10 centimetric visual analogic scale (VAS), where 0 means no pain and 10 is the worst pain possible;
•6. A score of >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.

•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).

发起方

aborest Spa