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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Visual Analogue Score [Срок оценки: Before treatment and at 1 2 3 and 6 weeks after treatment.]

Вторичные конечные точки (2)

• Width of soft tissue around joints [Срок оценки: Before treatment and at 1, 2, 3, and 6 weeks after treatment.]
• Lysholm knee score scale [Срок оценки: Before treatment and at 1, 2, 3, and 6 weeks after treatment.]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Science and Education Department of Changping District Integrated Traditional Chinese and — Пекин

Идентификаторы

NCT: NCT06911437 · LunShen(2023)No.09.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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