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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06451783
• Other study ID #: XuhuiCH202405
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Xuhui Central Hospital, Shanghai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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; ? Apply rolling technique around the knee joint; ? Knead and straighten the standing tendon (the lateral muscle of the calf); ? Six-finger six-acupoint pressing method; ? Push and pull the patella to flex and extend the knee joint; ? Knee joint reunion and smooth dispersion method.

Drug:
• Celecoxib capsule
Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.

Locations

Country	Name	City	State
China	Qiao Liang	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xuhui Central Hospital, Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The western Ontario and McMaster universities osteoarthritis index	The WOMAC consists of a series of questions that capture the patient's perception of pain, stiffness, and physical function over the past week. It is scored on a numerical scale, with higher scores indicating greater impairment. The index is often used in clinical trials and epidemiological studies to measure changes in osteoarthritis symptoms and to assess the effectiveness of treatments.	up to 13 weeks
Secondary	Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis	Stride Length in meters	up to 13 weeks
Secondary	Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis	Walking Speed in meters per second	up to 13 weeks
Secondary	Gait Speed in meters per second	Gait Analysis	up to 13 weeks