Clinical trial NCT06451783: Shengyu Decoction and Lijin Manipulation for Knee OA: 3D Gait Analysis
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Osteoarthritis of the Knee
Lead sponsor: Xuhui Central Hospital, Shanghai
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 94
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Combined treatment group：Traditional Chinese medicine combined with manipulation treatment Control group：Oral control group medication
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The western Ontario and McMaster universities osteoarthritis index
timeFrame: up to 13 weeks
Secondary outcomes:
measure: Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis
timeFrame: up to 13 weeks
measure: Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis
timeFrame: up to 13 weeks
measure: Gait Speed in meters per second
timeFrame: up to 13 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Qiao Liang
Study officials:
References: