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

Xuhui Central Hospital, Shanghai

Status and phase: Invitation-only; Early Phase 1

Conditions: Osteoarthritis of the Knee

Treatments: Other: Traditional Chinese medicine combined with manipulation treatment; Drug: Celecoxib capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06451783

XuhuiCH202405

Details and patient eligibility

About

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

Full description

This study aims to explore the efficacy of the Shengyu Decoction combined with manual therapy for the treatment of knee osteoarthritis (OA) using a clinical randomized controlled trial design. Additionally, based on three-dimensional gait analysis technology, the investigators will delve into the biomechanical mechanisms underlying the onset of knee OA and elucidate the mechanism of action of the Shengyu Decoction combined with manual therapy. This will further validate the clinical superiority of the Shengyu Decoction combined with manual therapy in the treatment of knee OA, providing strong support for reducing pain and improving knee function in patients with knee OA.

Enrollment: 94 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 2 patient groups

Combined treatment group

Experimental group

Description:

Traditional Chinese medicine combined with manipulation treatment：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.

Treatment:

Other: Traditional Chinese medicine combined with manipulation treatment

Control group

Active Comparator group

Description:

Oral control group medication： Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.

Treatment:

Drug: Celecoxib capsule