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

NCT06911437 | Enrolling By Invitation

• 1 other identifier: LunShen(2023)No.09.
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis (OA)

Keywords

Knee Osteoarthritis; pain; Swelling of soft tissues

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Score

  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.

  Before treatment and at 1 2 3 and 6 weeks after treatment.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Treatment group

Treatment with Xiaoyu Zhitong Formula combined with lymphatic drainage technique;

Other: treatment group

Control group

External application of Futalin combined with lymphatic drainage technique for treatment

Other: control group

Interventions

treatment group OTHER

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 supraclavicular fossa, and then perform freehand lymphatic drainage at the lymphatic vessels or superficial lymph nodes, according to the clockwise circle method, all the way to the outside of the thigh, and then to the lateral malleolus of the calf, and then press the medial malleolus of the inner calf to the inner thigh. 20min each time, 1 time every other day. 3 times a week for a total of 9 treatments for 3 weeks.

Treatment group

control group OTHER

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, according to the clockwise circle method, all the way to the outside of the thigh, and then to the lateral malleolus of the calf, and then press the medial malleolus of the inner calf to the inner thigh. 20min each time, 1 time every other day. 3 times a week for a total of 9 treatments for 3 weeks.

Control group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with cold dampness obstruction type knee joint pain

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• tang jie: lead

Study Sites (1)

Science and Education Department of Changping District Integrated Traditional Chinese and Western Medicine Hospital Beijing.No. 219 Huangping Road Huoying Changping District Beijing

Beijing, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Rehabilitation Department of the Hospital of Integrated Traditional Chinese and Western Medicine, Changping District, Beijing

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: April 4, 2025
• Study Start: October 10, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

CN (1)