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
March 28, 2025 updated by: tang jie
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Peking, China
- Science and Education Department of Changping District Integrated Traditional Chinese and Western Medicine Hospital Beijing.No. 219 Huangping Road Huoying Changping District Beijing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
patients with cold dampness obstruction type knee joint pain
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Treatment group
Treatment with Xiaoyu Zhitong Formula combined with lymphatic drainage technique;
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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. |
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Control group
External application of Futalin combined with lymphatic drainage technique for treatment
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Score
Time Frame: Before treatment and at 1 2 3 and 6 weeks after treatment.
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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.
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Before treatment and at 1 2 3 and 6 weeks after treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Width of soft tissue around joints
Time Frame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
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Use a tape measure to measure and record at the same position on the knee joint.A lower value indicates a better outcome.
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Before treatment and at 1, 2, 3, and 6 weeks after treatment.
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Lysholm knee score scale
Time Frame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
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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. |
Before treatment and at 1, 2, 3, and 6 weeks after treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2024
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
January 20, 2025
First Submitted That Met QC Criteria
March 28, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
March 28, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LunShen(2023)No.09.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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