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

tang jie

Status: Invitation-only

Conditions: Knee Osteoarthritis (OA)

Treatments: Other: treatment group; Other: control group

Study type: Observational

Funder types: Other

Identifiers

NCT06911437

LunShen(2023)No.09.

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. 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.

2. 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.

Trial design

100 participants in 2 patient groups

Treatment group

Description:

Treatment with Xiaoyu Zhitong Formula combined with lymphatic drainage technique;

Treatment:

Other: treatment group

Control group

Description:

External application of Futalin combined with lymphatic drainage technique for treatment

Treatment:

Other: control group