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ENROLLING BY INVITATION

NCT06451783

EARLY_PHASE1

Shengyu Decoction and Lijin Manipulation for Knee OA: 3D Gait Analysis

Sponsor: Xuhui Central Hospital, Shanghai

View on ClinicalTrials.gov

Summary

Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.

Official title: The Clinical Efficacy of Shengyu Decoction Combined With Lijin Manipulation in the Treatment of Knee Osteoarthritis Was Observed Based on Three-dimensional Gait Analysis System

Key Details

Gender

All

Age Range

45 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-01

Completion Date

2025-12-31

Last Updated

2024-06-11

Healthy Volunteers

Conditions

Osteoarthritis of the Knee

Interventions

OTHER

Traditional Chinese medicine combined with manipulation treatment

The specific procedure involves administering the Shengyu Decoction, which consists of the following herbs: * Shu Di Huang 20 grams * Bai Shao 15 grams * Dang Gui 15 grams * Chuan Xiong 8 grams * Ren Shen 20 grams * Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks. Add manipulation of massage： * Press and grasp the affected limb three times； * Five-finger five-acupoint pressing method； * Point pressing on Zusanli (ST36) and Sanyinjiao (SP6)； * grasp the interior method to treat the calf three times； ⑤ Apply rolling technique around the knee joint； ⑥ Knead and straighten the standing tendon (the lateral muscle of the calf)； ⑦ Six-finger six-acupoint pressing method； ⑧ Push and pull the patella to flex and extend the knee joint； ⑨ Knee joint reunion and smooth dispersion method.

DRUG

Celecoxib capsule

Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.

Inclusion Criteria: * Diagnostic criteria of Western medicine: Knee pain for at least 1 month, X-ray showing osteophyte formation, age ≥50 years, morning stiffness ≤30 min, and bone fricative sound. * TCM diagnostic criteria: Dull pain in the knee joint, flexion and extension limitations, pitching and side rotation unfavorability, slight activities slightly relieve pain, climate change aggravates symptoms, and repeated middle-aged and elderly patients, hidden onset, slow onset, slight local swelling of the knee joint, friction or clicking sound when moving, and severe cases may show muscle atrophy and joint deformity. * Radiographs showing joint space narrowing, bone hyperplasia, subchondral osteosclerosis, and osteophyte formation. * Patients who are between 45 and 85 years old. * Patients who can understand and provide informed consent. * Patients who are willing and able to undergo manual treatment for 1 course of treatment and cooperate with the doctor to complete the study. Exclusion Criteria: * Patients who do not meet the diagnostic criteria for knee osteoarthritis established by the rheumatology society. * Severe knee pain with surgical indications (or X-ray grading standards reached level 4). * Pregnant or planning to become pregnant. * Patients who have participated in or are participating in other clinical trials within the last 3 months. * Patients who have received or are receiving other treatment methods such as drugs that affect the evaluation of efficacy within the past 3 months. * Patients with fractures, dislocation, skin damage, and severe infectious skin diseases within three weeks. * Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardiovascular and cerebrovascular, nervous system, tuberculosis, joint malformations, tumors, and psychiatric patients and postoperative patients. * Patients who are unable to accurately evaluate the effectiveness and safety of treatment due to their medical condition.

Locations (1)

Qiao Liang

Shanghai, China