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

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: LA-400 laser acupuncture

• Registration Number: NCT04275427
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-03
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-16
• Last Update Submitted: 2020-02-16
• Study First Posted: 2020-02-19
• Last Update Posted: 2020-02-19
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Kellgren-Lawrence grade II ~ III

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study laser group	LA-400 laser acupuncture	laser therapy on knee for 2 weeks

Primary Outcome Measures

Name	Time	Method
difference on MRI post- versus pre- treatment	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

Secondary Outcome Measures

Name	Time	Method
Improve stability on movement analysis	2 weeks	Calculate the area of center of posture (COP) during the movement. Suppose that the lower value, the higher stability.

Trial Locations

Locations (1)

ShinKongHospital; 🇨🇳 Taipei, Taiwan