Back to resultsThe Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
LA-400 laser acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Kellgren-Lawrence grade II ~ III
Exclusion Criteria:
- Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy
Sites / Locations
- ShinKongHospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study laser group
control group
Arm Description
laser therapy on knee for 2 weeks
no intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Improve stability on movement analysis
Calculate the area of center of posture (COP) during the movement. Suppose that the lower value, the higher stability.
Full Information
NCT ID
NCT04275427
First Posted
February 6, 2020
Last Updated
February 16, 2020
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04275427
Brief Title
The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
Official Title
The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study laser group
Arm Type
Experimental
Arm Description
laser therapy on knee for 2 weeks
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Device
Intervention Name(s)
LA-400 laser acupuncture
Intervention Description
low level laser
Primary Outcome Measure Information:
Title
difference on MRI post- versus pre- treatment
Description
compare the apparent diffusion coefficient (ADC) value post- and pre- treatment, suppose that the higher the value, the less inflammation in target tissue
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Improve stability on movement analysis
Description
Calculate the area of center of posture (COP) during the movement. Suppose that the lower value, the higher stability.
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
decreased WOMAC score
Description
The Western Ontario and McMaster Universities Osteoarthritis Index, pain(0-20), stiffness(0-8), functional limitation(0-68). The higher the score, the worse the pain, stiffness and limitation
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Kellgren-Lawrence grade II ~ III
Exclusion Criteria:
Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching Wen Huang, M.D.
Phone
886-2-28332211
Ext
2147
Email
b318is2002@yahoo.com.tw
Facility Information:
Facility Name
ShinKongHospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ChingWen Huang, MD
Phone
0228332211
Ext
2147
Email
b318is2002@yahoo.com.tw
12. IPD Sharing Statement
Learn more about this trial
The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
We'll reach out to this number within 24 hrs