Abstract
BackgroundKnee osteoarthritis (OA) is considered a major public health issue causing chronic disability worldwide with the increasing number of aging people. In China and increasingly worldwide, many sufferers with knee OA are using complementary and alternative medicine including herbal drug, herbal patch, acupuncture and Tuina etc., to alleviate their symptoms. However, evidence gathered from systematic reviews or randomized controlled trials (RCT) has only validated acupuncture for the management of osteoarthritic pain. Moreover, such Traditional Chinese Medicine (TCM) methods above are commonly used in an integrative way. This trial is aimed to compare the efficacy of an individually integrated TCM approach in the management of knee OA with other single treatments as parallel randomized controls.Methods/designFive teaching hospitals will participate in this randomized controlled trial. 500 participants, 100 in each hospital, will be randomly assigned to receive oral administration of a Chinese herbal drug (counter osteophytes capsule), topical use of a Chinese herbal patch (Fufnag Zijin patch), acupuncture, Tuina and the individually integrated TCM approach. The individually integrated TCM approach consists of basic treatment of oral counter osteophytes capsule, variable use of Tuina, acupuncture and a herbal patch based on the severity of the patient's symptoms.The interventions are given for a period of 4 weeks. The primary outcome measure is the self-reported total score using the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures include patient and investigator global assessment of response to treatment, patient and investigator global assessment of OA condition, WOMAC pain, stiffness, and physical function subscales, short-form 36 (SF-36) and TCM assessment of OA condition measured by syndromes questionnaire. Mixed models and sensitivity analysis will be used for the statistical analysis.DiscussionThe trial is designed to test the hypothesis that an individually integrated TCM approach is more effective than four treatment modalities used separately. The major limitation of this study is lack of placebo control and of double blinding.Trial RegistrationChinese Cochrane Center ChiCTR-TRC-00000176
Highlights
Knee osteoarthritis (OA) is considered a major public health issue causing chronic disability worldwide with the increasing number of aging people
The trial is designed to test the hypothesis that an individually integrated Traditional Chinese Medicine (TCM) approach is more effective than four treatment modalities used separately
OA is characterized by a series of pathological changes in the whole joint, including cartilage loss, bone remolding, excess synovial fluid secretion, capsular swelling, inflammation in the synovium, bone marrow lesions, muscle weakness and atrophy resulting in bone thickening and formation of bone growths or spurs that interfere with joint movement [1,2]
Summary
Osteoarthritis (OA), the most common form of arthritis, is a chronic, degenerative, joint disease that affects mostly middle-aged and older adults. The counter osteophytes capsule, an extract from Radix Rehamanniae (Dihuang) and Herbal Cistanches (Roucongrong), is a Traditional Chinese herb used for symptomatic treatment of inflammation and pain in osteoarthritis. The approach consists of a basic treatment of orally administered Chinese herbal drugs and varying use of Tuina, acupuncture and herbal patch, all based on the severity of the patient symptoms. We initiated this study to compare the efficacy of an individually integrated TCM approach, Chinese herb counter osteophytes capsule, Fufang Zijin patch, acupuncture and Tuina in the short-term, symptomatic treatment of OA of the knee. We hypothesized that the integrated TCM approach is more effective than the four treatments, oral medication, topical patch, acupuncture or Tuina, when used alone
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