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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Other: Traditional Chinese medicine combined with manipulation treatment; Drug: Celecoxib capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Qiao Liang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined treatment group; 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.	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.
Active Comparator: Control group; Oral control group medication： Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.	Drug: Celecoxib capsule; Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis	Stride Length in meters	up to 13 weeks
Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis	Walking Speed in meters per second	up to 13 weeks
Gait Speed in meters per second	Gait Analysis	up to 13 weeks

Collaborators and Investigators

• Sponsor: Xuhui Central Hospital, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: XuhuiCH202405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No