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Not yet recruitingNCT06335602Updated Mar 28, 2024

TCM for Post-operative Edema

An interventional study of LASER acupuncture in Anterior Cruciate Ligament Injuries, sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Anterior Cruciate Ligament Injuries
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's planned enrollment of 120 is above the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Laser Acupuncture Treat

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

    Device: LASER acupuncture

  • Sham comparator
    Laser Acupuncture Sham

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

    Device: LASER acupuncture

  • Active comparator
    Herbal packing

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

    Device: LASER acupuncture

Interventions

  • DeviceLASER acupuncture

    Low level LASER therapy

06

What researchers measure

Primary outcomes

  1. Leg girth measurement

    lower limb multiple girth measurement

    Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

Secondary outcomes

  1. VAS

    general scoring of pain

    Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

  2. WOMAC

    specific scoring of joint pain

    Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

  3. Tegner score

    scoring of joint activity

    Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06335602
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
YI-WEN HSIEH (Attending physician, Chang Gung Memorial Hospital) — Principal investigator
First posted
Mar 28, 2024
Start date
Mar 30, 2024 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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