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

NCT ID: NCT06451783

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Combined treatment group:Traditional Chinese medicine combined with manipulation treatment Control group:Oral control group medication
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Traditional Chinese medicine combined with manipulation treatment

Intervention Type OTHER

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.

Control group

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

Group Type ACTIVE_COMPARATOR

Celecoxib capsule

Intervention Type DRUG

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

Interventions

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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.

Intervention Type OTHER

Celecoxib capsule

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuhui Central Hospital, Shanghai

OTHER

Sponsor Role lead

Responsible Party

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Liang Qiao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qiao Liang

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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XuhuiCH202405

Identifier Type: -

Identifier Source: org_study_id

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