TCM for Post-operative Edema

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

The Evaluation of Traditional Chinese Medicine Intervention for Post-operative Edema After Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335602
• Other study ID #: 202301283A3
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Device:
• LASER acupuncture
Low level LASER therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg girth measurement	lower limb multiple girth measurement	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Secondary	VAS	general scoring of pain	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Secondary	WOMAC	specific scoring of joint pain	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Secondary	Tegner score	scoring of joint activity	before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation