A randomized controlled trial to compare the effect of a novel marine extract (BioLex (Registered Trademark)) with placebo, on measures of pain (VAS) and physical function (Womac) in patients with osteoarthritis of the hip and/or knee.

Dr Tony Schneiders0 个研究点目标入组 90 人开始时间: 2011年3月8日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Patients suspected of having Osteoarthritis:
•(i) Knee or hip osteoarthritis fulfilling the American College of Rheumatology classification criteria with pain on most days of the past month and radiological changes (osteophytes and joint space narrowing) indicative of OA.
•(ii) Overall average hip/groin or knee pain in the last week >30 on 100 mm visual analogue scale (VAS) (to ensure a minimal level of pain);
•(iii) Pain in the groin, hip or knee region for more than 3 months;
•(iv) Disability related to their arthritis defined as a score of at least 0.5 on the Health Assessment Questionnaire (HAQ)
•(v) Aged >18 years.

•(i) Hip or knee surgery within past 6 months;
•(ii) Awaiting or planning any back or lower limb surgery in the next 3 months;
•(iii) Current or recent (in the last 3 months) oral or intraarticular corticosteroid therapy;
•(iv) Inflammatory arthritis such as rheumatoid arthritis;
•(v) History of hip or knee joint replacement or osteotomy at index joint;
•(vi) Other previous hip or knee pathology such as a recent fracture (<3 months) or malignancy at the index joint;
•(vii) Other co-existent muscular, joint or neurological condition causing pain or affecting lower limb function (e.g. trauma, shingles);
•(viii) Any medical or physical impairment apart from hip or knee OA precluding safe participation in exercise/function based assessments such as uncontrolled hypertension, fibromyalgia, chronic fatigue syndrome or morbid obesity (body mass index > 40);
•(ix) Seafood or corn hypersensitivity or allergy;
•(x) Inability to comply with study protocol;
•(xi) Inadequate written and spoken English;
•(xii) Psychiatric illness – major depressive illness or psychosis;
•(xiii) Pregnancy;
•(xiv) Inter-current acute infections.

发起方

Dr Tony Schneiders