Osteoarthritis (knee, hip, finger joints, etc.)
Conditions
Interventions
Traditional Chinese Medicine Group:Gui Zhi Fu Zi Decoction
Western Medicine Group:Conventional therapy (oral nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics, disease-modifying drugs, anxiolytics, among others)
Sponsors
Chongqing Hygeia Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Patients with OA who meet the diagnostic criteria of traditional Chinese medicine (TCM) pattern differentiation and Western medicine. (2) Unilateral knee involvement, with Kellgren–Lawrence radiographic grade 0–III. (3) Age 50–70 years, any gender. (4) No other related treatment within 2 weeks prior to this treatment, and no other treatments during the treatment period. (5) VAS score = 6. (6) Voluntary participation and signed informed consent. Among the inclusion criteria, the referenced other criteria are as follows: Western Medicine Diagnostic Criteria Refer to the Chinese Guidelines for Diagnosis and Treatment of Osteoarthritis (2021 Edition) and the 2019 TCM Orthopedics and Traumatology Clinical Practice Guidelines as reference standards, as detailed below: 1) Recurrent joint pain within the past 1 month. 2) Weight-bearing radiographs of the joint showing joint space narrowing, subchondral bone sclerosis and/or cystic changes, and marginal osteophyte formation. 3) Age = 50 years. 4) Morning stiffness duration = 30 min. 5) Crepitus on joint movement. Note: Diagnosis of OA requires item 1) plus any two of items 2), 3), 4), and 5). TCM Diagnostic Criteria Refer to the diagnostic criteria in the Guidelines for Diagnosis and Treatment of Osteoarthritis with Disease Pattern Combination. Primary symptoms: 1) Cold pain of the joint with or without swelling; 2) Fixed pain aggravated by cold. Secondary symptoms: 1) Cold and heavy sensation in the limbs; 2) Preference for warmth and fear of cold; 3) Loose stools or clear urine. Tongue and pulse: Pale tongue, white greasy coating; wiry and tense pulse or deep and moderate pulse. Diagnosis is established by the presence of two primary symptoms, or one primary symptom plus two secondary symptoms, in combination with the tongue and pulse findings. Kellgren & Lawrence Radiographic Grading Scale Grade 0: No changes. Grade I: Doubtful narrowing of joint space, possible osteophytes. Grade II: Mild narrowing of joint space, definite small osteophytes. Grade III: Definite joint space narrowing, moderate osteophytes, mild subchondral bone sclerosis, possible joint deformity. Grade IV: Severe joint space narrowing, large osteophytes, marked subchondral bone sclerosis, obvious joint enlargement and deformity.
Exclusion criteria
Exclusion criteria: (1) Patients with tuberculosis of bone and joint, tumors, rheumatoid arthritis, rheumatoid arthritis, and other inflammatory pain-related diseases. (2) Patients with severe primary diseases or mental disorders. (3) Women in lactation period, pregnancy, or preparing for pregnancy. (4) Patients with skin diseases or skin ulcers around the affected joint. (5) Patients with coagulation dysfunction. (6) Patients allergic to traditional Chinese medicine or unable to tolerate it. (7) Patients who received hormone therapy within the joint cavity within the past 60 days, or had intra-cavity injections or arthroscopic examinations on the affected joint within the past 3 months, or had trauma or surgery on the affected area within the past 6 months. (8) Patients who need painkillers for reasons other than osteoarthritis (OA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Efficacy Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale score;WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) score;Traditional Chinese Medicine syndrome score;The MOS item short form health survey Score;Serum Interleukin-1ß?;Serum Tumor Necrosis Factor--a;Serum Cartilage Oligomeric Matrix Protein;Serum cartilage acidic protein1; | — |
Countries
China
Contacts
Public ContactZhang Wenliang
Chongqing Hygeia Hospital
Outcome results
None listed