Clinical Study on the Combination of Xiaoyu Zhitong Formula and Lymphatic Drainage Technique to Improve the Symptoms of Knee Pain and Swelling in Cold Dampness Obstruction Type
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visual Analogue Score
Study Overview
Brief Summary
This research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. The improvement of knee joint pain scores and activity function as well as the degree of soft tissue swelling changes are observed before and after receiving this therapy providing certain ideas for the comprehensive treatment optimization and prognosis judgment of cold dampness obstruction type knee joint pain.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a. Patients who meet the diagnostic criteria for knee osteoarthritis in the "Guidelines for Diagnosis and Treatment of Osteoarthritis" (2007 edition) of the Chinese Medical Association Orthopedic Branch and also meet the diagnostic criteria for wind cold dampness syndrome of knee joint obstruction;
- •b. Age range: 25-70 years old;
- •c.1 week ≤ disease duration ≤ 2 years;
- •d. If other treatments have already been received and there is a washout period of more than 14 days;
- •e. Voluntarily participate in the study and sign an informed consent form.
Exclusion Criteria
- •a. Patients with bleeding tendencies severe skin damage or skin diseases in certain areas;
- •b. Suspected or diagnosed with tumors;
- •c. Patients with severe heart lung brain diseases tuberculosis osteomyelitis and osteoporosis;
- •d. Patients with mental illnesses;
- •e. Pregnant or planned pregnant women and lactating women;
- •f. Have participated in other clinical studies within the past 3 months;
- •g. The researchers believe that they are not suitable to participate in this clinical study due to other reasons.
Outcomes
Primary Outcomes
Visual Analogue Score
Time Frame: Before treatment and at 1 2 3 and 6 weeks after treatment.
This method is relatively sensitive and comparable. The specific method is to draw a 10 cm horizontal line on the paper with one end of the line marked as 0 indicating no pain; The other end is 10 indicating severe pain; The middle part represents varying degrees of pain. Ask the patient to draw a mark on the horizontal line based on their own feelings to indicate the degree of pain. The pain score is determined by measuring the length of the mark from the 0 point is the pain score.Quantitative score: A higher score indicates a worse outcome, with 0 being no pain and 10 being the most painful.
Secondary Outcomes
- Width of soft tissue around joints(Before treatment and at 1, 2, 3, and 6 weeks after treatment.)
- Lysholm knee score scale(Before treatment and at 1, 2, 3, and 6 weeks after treatment.)
Investigators
tang jie
Director of the Rehabilitation Department of the Hospital of Integrated Traditional Chinese and Western Medicine, Changping District, Beijing
Beijing Municipal Health Commission