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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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06911437
Enrollment
100
Registered
2025-04-04
Start date
2024-10-10
Completion date
2026-03-31
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis (OA)

Keywords

Knee Osteoarthritis, pain, Swelling of soft tissues

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.

Interventions

OTHERtreatment 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 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.

OTHERcontrol 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, 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.

Sponsors

tang jie
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue ScoreBefore 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

MeasureTime frameDescription
Width of soft tissue around jointsBefore treatment and at 1, 2, 3, and 6 weeks after treatment.Use a tape measure to measure and record at the same position on the knee joint.A lower value indicates a better outcome.
Lysholm knee score scaleBefore treatment and at 1, 2, 3, and 6 weeks after treatment.Quantitative scoring: Higher scores indicate better outcomes and fewer symptoms or disabilities. Qualitative scoring:A score of 95 or above is excellent, 94-85 is good, 84-65 is acceptable, and less than 65 is poor.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026