Osteoarthritis, KneeNCT04275427
The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
A study testing LA-400 laser acupuncture in people with Osteoarthritis, Knee, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
To study the efficacy of laser acupuncture on osteoarthritis (OA) knee patients by magnetic resonance imaging (MRI), clinical evaluation and movement analysis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- LA-400 laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kellgren-Lawrence grade II ~ III
Who cannot join
- Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
ShinKongHospital
Taipei, 111
ChingWen Huang, MD, 0228332211 ext. 2147, b318is2002@yahoo.com.tw
About this study
To study the efficacy of laser acupuncture on osteoarthritis (OA) knee patients by magnetic resonance imaging (MRI), clinical evaluation and movement analysis.
Read the detailed description
The Kellgren-Lawrence (KL) grading scheme for OA knee
Patient selecting flow Age: 20-70 year old Grade II-III knee OA Exlusion: Trauma history/ Space claustrophobia /Severe chronic disease/ Malignancy Pregnancy Study Cases 40 Randomize Pre-treatment MRI (to evaluate grade of OA knee/ the T2 signal of the cartilage), MRS (baseline glutamate), Movement analysis(sit to stand), Maximum strength ratio of Quadriceps/Hamstring WOMAC Post-treatment evaluation laser therapy Modality: LA-400 Treatment protocol of low level laser
- 40mW, 50Hz, 808nm (invisible light) , 15min
- The effect of laser acupuncture is dose dependent Effect of Laser Therapy on Chronic Osteoarthritis of the Knee in Older SubjectsJ Lasers Med Sci. 2016 Spring; 7(2): 112-119
- 830nm is an effective form of treatment for chronic knee pain caused by knee osteoarthritis. Low Level Laser Therapy for chronic knee joint pain patientsLaser Ther. 2014 Dec 27; 23(4): 273-277
- Duration: 2 weeks Frequency: 3 times/week
- Control group: no treatment Acupuncture point: EX- LE-5, EX-EL 2, SP10
- Conditions
- Osteoarthritis, Knee
- Being tested
- LA-400 laser acupuncture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LA-400 laser acupunctureDevice
low level laser
| Study group | Role | What they receive |
|---|---|---|
| study laser group | Experimental | laser therapy on knee for 2 weeks Receives: Device: LA-400 laser acupuncture |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference on MRI post- versus pre- treatment
compare the apparent diffusion coefficient (ADC) value post- and pre- treatment, suppose that the higher the value, the less inflammation in target tissue
Measured: 2 weeks
Secondary outcomes (1)
Improve stability on movement analysis
Calculate the area of center of posture (COP) during the movement. Suppose that the lower value, the higher stability.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275427
- Sponsor's protocol ID
- 20171103R
- Status last verified
- Mar 2019
- First submitted
- 6 Feb 2020
- Last updated
- 19 Feb 2020
- 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
- ClinicalTrials.gov ID
- NCT04275427
- Acronym / sponsor ID
- 20171103R
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 19 Feb 2020 (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.
To study the efficacy of laser acupuncture on osteoarthritis (OA) knee patients by magnetic resonance imaging (MRI), clinical evaluation and movement analysis.
Detailed description
The Kellgren-Lawrence (KL) grading scheme for OA knee
Patient selecting flow Age: 20-70 year old Grade II-III knee OA Exlusion: Trauma history/ Space claustrophobia /Severe chronic disease/ Malignancy Pregnancy Study Cases 40 Randomize Pre-treatment MRI (to evaluate grade of OA knee/ the T2 signal of the cartilage), MRS (baseline glutamate), Movement analysis(sit to stand), Maximum strength ratio of Quadriceps/Hamstring WOMAC Post-treatment evaluation laser therapy Modality: LA-400 Treatment protocol of low level laser
- 40mW, 50Hz, 808nm (invisible light) , 15min
- The effect of laser acupuncture is dose dependent Effect of Laser Therapy on Chronic Osteoarthritis of the Knee in Older SubjectsJ Lasers Med Sci. 2016 Spring; 7(2): 112-119
- 830nm is an effective form of treatment for chronic knee pain caused by knee osteoarthritis. Low Level Laser Therapy for chronic knee joint pain patientsLaser Ther. 2014 Dec 27; 23(4): 273-277
- Duration: 2 weeks Frequency: 3 times/week
- Control group: no treatment Acupuncture point: EX- LE-5, EX-EL 2, SP10
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study laser group | Experimental | Device: LA-400 laser acupuncturelaser therapy on knee for 2 weeks |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kellgren-Lawrence grade II ~ III
Key exclusion criteria (1 listed)
- Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy
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 |
|---|---|---|
| LA-400 laser acupuncturelow level laser | Device | study laser group |
Primary outcome
difference on MRI post- versus pre- treatment
Time frame: 2 weeks
compare the apparent diffusion coefficient (ADC) value post- and pre- treatment, suppose that the higher the value, the less inflammation in target tissue
1 secondary outcome
Improve stability on movement analysis
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LA-400 laser acupuncture in people with Osteoarthritis, Knee, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Ching Wen Huang, M.D. (886-2-28332211 ext. 2147, b318is2002@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference on MRI post- versus pre- treatment (time frame: 2 weeks). 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 19 Feb 2020.