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TCM for Post-operative Edema

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06335602
Enrollment
120
Registered
2024-03-28
Start date
2024-03-30
Completion date
2025-12-31
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

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.

Interventions

DEVICELASER acupuncture

Low level LASER therapy

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Leg girth measurementbefore operation, day of operation, 1 day/ 2weeks/ 4weeks after operationlower limb multiple girth measurement

Secondary

MeasureTime frameDescription
VASbefore operation, day of operation, 1 day/ 2weeks/ 4weeks after operationgeneral scoring of pain
WOMACbefore operation, day of operation, 1 day/ 2weeks/ 4weeks after operationspecific scoring of joint pain
Tegner scorebefore operation, day of operation, 1 day/ 2weeks/ 4weeks after operationscoring of joint activity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026