Anterior Cruciate Ligament InjuriesNCT06335602
TCM for Post-operative Edema
A study testing LASER acupuncture in people with Anterior Cruciate Ligament Injuries, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- LASER acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: The Evaluation of Traditional Chinese Medicine Intervention for Post-operative Edema After Cruciate Ligament Reconstruction
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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- LASER acupuncture
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER acupunctureDevice
Low level LASER therapy
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture Treat | Experimental | Low level laser therapy to acupoints related to operation wound, before and after operation Receives: 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 Receives: Device: LASER acupuncture |
| Herbal packing | Active comparator | External application of herbal medicine packing around the operation wound, before and after operation Receives: Device: LASER acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg girth measurement
lower limb multiple girth measurement
Measured: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Secondary outcomes (3)
VAS
general scoring of pain
Measured: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
WOMAC
specific scoring of joint pain
Measured: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Tegner score
scoring of joint activity
Measured: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI-WEN HSIEH, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335602
- Sponsor's protocol ID
- 202301283A3
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Traditional Chinese Medicine Intervention for Post-operative Edema After Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06335602
- Acronym / sponsor ID
- 202301283A3
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture Treat | Experimental | Device: LASER acupunctureLow level laser therapy to acupoints related to operation wound, before and after operation |
| Laser Acupuncture Sham | Sham comparator | Device: LASER acupunctureLow level laser therapy(with Sham device) to acupoints related to operation wound, before and after operation |
| Herbal packing | Active comparator | Device: LASER acupunctureExternal application of herbal medicine packing around the operation wound, before and after operation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASER acupunctureLow level LASER therapy | Device | Herbal packing, Laser Acupuncture Sham, Laser Acupuncture Treat |
Primary outcome
Leg girth measurement
Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
lower limb multiple girth measurement
3 secondary outcomes
VAS
Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
WOMAC
Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Tegner score
Time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LASER acupuncture in people with Anterior Cruciate Ligament Injuries, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg girth measurement (time frame: before operation, day of operation, 1 day/ 2weeks/ 4weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.