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
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: treatment group, control group.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis (OA). Basic parameters: 25 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other treatment group
Xiaoyu Zhitong Formula: 10g of long pepper, 10g of cloves, 10g of borneol, 10g of papaya, 10g of white peony, 10g of licorice, 15g of chicken blood vine, 10g psoralen, 10g of cistanche, powdered petroleum jelly, wrapped in gauze and heated and applied to the affected area. Freehand lymphatic drainage technique: the patient is in the supine position, first use the thumb to press the deep lymph nodes of the trunk for 3-5 min, which are lymph nodes in the groin, neck, lumbosacral spine and supracl - Other control group
External application of Diclofenac Diethylamine Emulgel（Manufacturer: Switzerland,Haleon CH SARL） combined with lymphatic drainage technique for treatment，Freehand lymphatic drainage technique: the patient is in the supine position, first use the thumb to press the deep lymph nodes of the trunk for 3-5 min, which are lymph nodes in the groin, neck, lumbosacral spine and supraclavicular fossa, and then perform freehand lymphatic drainage at the lymphatic vessels or superficial lymph nodes, accord
Primary outcome measures
- Visual Analogue Score [Time frame: Before treatment and at 1 2 3 and 6 weeks after treatment.]
Secondary outcome measures (2)
- Width of soft tissue around joints [Time frame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.]
- Lysholm knee score scale [Time frame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.]
Eligibility criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Science and Education Department of Changping District Integrated Traditional Chinese and — Beijing
Identifiers
NCT: NCT06911437 · LunShen(2023)No.09.