TCM for Post-operative Edema

NCT ID: NCT06335602

Last Updated: 2024-03-28

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2025-12-31

Brief Summary

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There are loads of research on knee surgery, including surgical methods, rehabilitation strategies, and complication prevention. Whether it is general surgery or endoscopic surgery, there may be postoperative joint swelling, which may last for several weeks depending on the patient's condition. Therefore, reducing swelling as soon as possible is important in post-operative treatment. Swelling of the knee joint may increase soft tissue tension, causing pain and discomfort, and affecting the range of motion and functional recovery of the joint. It may also affect wound healing and increase the risk of complications such as infection and thrombosis. Most clinical research related to traditional Chinese medicine focuses on reducing pain, and little attention is paid to reducing swelling, relatively. Nevertheless most relevant literatures discuss total knee replacement surgery.

Cruciate ligament surgery is very common in sports medicine orthopedics. It is expected that ordinary patients get function recovery quickly after surgery, and athletes can return to play as soon as possible. This study is a prospective study, with partially double-blinded, randomized controlled study design. The investigators are aiming to TCM intervention for knee swelling after cruciate ligament surgery, and evaluation of postoperative swelling and functional improvement. TCM intervention methods are laser acupuncture and external application of herbal medicine.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Laser Acupuncture Treat

Low level laser therapy to acupoints related to operation wound, before and after operation

Group Type EXPERIMENTAL

LASER acupuncture

Intervention Type DEVICE

Low level LASER therapy

Laser Acupuncture Sham

Low level laser therapy(with Sham device) to acupoints related to operation wound, before and after operation

Group Type SHAM_COMPARATOR

LASER acupuncture

Intervention Type DEVICE

Low level LASER therapy

Herbal packing

External application of herbal medicine packing around the operation wound, before and after operation

Group Type ACTIVE_COMPARATOR

LASER acupuncture

Intervention Type DEVICE

Low level LASER therapy

Interventions

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LASER acupuncture

Low level LASER therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Willing to sign informed consent
2. Age between 18-50 years old male and female patients
3. First time receiving cruciate ligament reconstruction
4. Willing to accept TCM intervention and follow up

Exclusion Criteria

1. Repeat surgical intervention
2. History of serious acupuncture syncope
3. History of severe allergic response of herbal packing or drug-induced dermatitis
4. History of other diseases that cause knee joint swelling, such as rheumatoid arthritis, knee joint infection, gouty arthritis, connective tissue disease, tumor, or cardiac/renal failure.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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YI-WEN HSIEH

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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202301283A3

Identifier Type: -

Identifier Source: org_study_id

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