TCM for Post-operative Edema

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Device: LASER acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06335602

202301283A3

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Laser Acupuncture Treat

Experimental group

Description:

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

Treatment:

Device: LASER acupuncture

Laser Acupuncture Sham

Sham Comparator group

Description:

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

Treatment:

Device: LASER acupuncture

Herbal packing

Active Comparator group

Description:

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

Treatment:

Device: LASER acupuncture