NCT06335602

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

March 7, 2024

Last Update Submit

March 21, 2024

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

  • Leg girth measurement

    lower limb multiple girth measurement

    before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

Secondary Outcomes (3)

  • VAS

    before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

  • WOMAC

    before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

  • Tegner score

    before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation

Study Arms (3)

Laser Acupuncture Treat

EXPERIMENTAL

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

Device: LASER acupuncture

Laser Acupuncture Sham

SHAM COMPARATOR

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

Device: LASER acupuncture

Herbal packing

ACTIVE COMPARATOR

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

Device: LASER acupuncture

Interventions

LASER acupunctureDEVICE

Low level LASER therapy

Herbal packingLaser Acupuncture ShamLaser Acupuncture Treat

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Willing to sign informed consent
  • Age between 18-50 years old male and female patients
  • First time receiving cruciate ligament reconstruction
  • Willing to accept TCM intervention and follow up

You may not qualify if:

  • Repeat surgical intervention
  • History of serious acupuncture syncope
  • History of severe allergic response of herbal packing or drug-induced dermatitis
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 28, 2024

Study Start

March 30, 2024

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

March 28, 2024

Record last verified: 2024-03