Clinical trial NCT06911437: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Knee Osteoarthritis (OA)
Keywords: Knee Osteoarthritis
pain
Swelling of soft tissues
Lead sponsor: Beijing Municipal Health Commission
Sponsor class: OTHER_GOV
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with cold dampness obstruction type knee joint pain

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.


Eligibility 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.

Primary outcomes:
measure: Visual Analogue Score
timeFrame: Before treatment and at 1 2 3 and 6 weeks after treatment.
Secondary outcomes:
measure: Width of soft tissue around joints
timeFrame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
measure: Lysholm knee score scale
timeFrame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
Other outcomes:
Locations:
city: Peking
country: China
facility: Science and Education Department of Changping District Integrated Traditional Chinese and Western Medicine Hospital Beijing.No. 219 Huangping Road Huoying Changping District Beijing
Study officials:
References: