TCM for Post-operative Edema

Not Applicable

Not yet recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Device: LASER acupuncture

• Registration Number: NCT06335602
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Study Start: 2024-03-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Acupuncture Sham	LASER acupuncture	Low level laser therapy(with Sham device) to acupoints related to operation wound, before and after operation
Herbal packing	LASER acupuncture	External application of herbal medicine packing around the operation wound, before and after operation
Laser Acupuncture Treat	LASER acupuncture	Low level laser therapy to acupoints related to operation wound, before and after operation

Primary Outcome Measures

Name	Time	Method
Leg girth measurement	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation	lower limb multiple girth measurement

Secondary Outcome Measures

Name	Time	Method
Tegner score	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation	scoring of joint activity
VAS	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation	general scoring of pain
WOMAC	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation	specific scoring of joint pain