Knee Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects in this study were diagnosed in accordance with the Clinical Guidelines for TCM Orthopedics & Traumatology: Knee Bi Disease (Knee Osteoarthritis) formulated by China Association of Chinese Medicine. The diagnostic criteria are as follows: 1) Knee pain present for most days within the past month; 2) Osteophyte formation observed on X-ray radiographs; 3) Joint fluid examination consistent with osteoarthritis; 4) Age = 40 years; 5) Morning stiffness duration = 30 minutes; 6) Presence of bony crepitus during joint movement. A diagnosis of knee osteoarthritis is confirmed if one of the following combinations is satisfied: 1) + 2), or 1) + 3) + 5) + 6), or 1) + 4) + 5) + 6). Additional inclusion criteria for participants: 1.Meet the above diagnostic criteria for knee osteoarthritis; 2.Aged between 40 and 75 years old; 3.Capable of completing functional tasks including sit-to-stand transfers and stair ascent/descent; 4.Lesions confined to a single knee, or predominant symptomatic manifestations in one knee; 5.Voluntarily participate in the trial, sign the informed consent form, and commit to completing the full course of treatment; 6.Numerical Rating Scale (NRS) pain score = 3 and < 7.
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: 1) patients combined with knee sprain, contusion or other traumatic injuries; 2) patients with bony ankylosis resulting from osseous bridging between articular spaces on X-ray films; 3) patients with severe lower limb joint deformity accompanied by obvious redness, swelling, heat and pain with local burning heat on palpation, who are differentiated as damp-heat bi obstruction syndrome by traditional Chinese medicine syndrome differentiation; 4) patients with previous knee surgery or arthroscopic treatment history; 5) patients complicated with severe visceral diseases, severe metabolic disorders or bone tumors; 6) patients receiving immunosuppressants, topical adrenal cortical hormones or TCM rehabilitation therapies within 4 weeks prior to enrollment; 7) patients with mental illness or intellectual disabilities, as well as pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical Pain Rating Scale;30-Second Sit-to-Stand Test;Timed Up and Go Test;Functional Near-Infrared Spectroscopy;Surface Electromyography; | — |
Countries
China
Contacts
Fujian University of Traditional Chinese Medicine