The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis

Osteoarthritis, Knee Clinical Trial

Official title:

The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275427
• Other study ID #: 20171103R
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2019
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: Ching Wen Huang, M.D.
• Phone: 886-2-28332211
• Email: b318is2002[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the efficacy of laser acupuncture on osteoarthritis (OA) knee patients by magnetic resonance imaging (MRI), clinical evaluation and movement analysis.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Kellgren-Lawrence grade II ~ III

Exclusion Criteria:

• Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• LA-400 laser acupuncture
low level laser

Locations

Country	Name	City	State
Taiwan	ShinKongHospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	decreased WOMAC score	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	2 weeks
Primary	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	2 weeks
Secondary	Improve stability on movement analysis	Calculate the area of center of posture (COP) during the movement. Suppose that the lower value, the higher stability.	2 weeks