NCT04275427

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 19, 2020

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

February 6, 2020

Last Update Submit

February 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Improve stability on movement analysis

    2 weeks

Other Outcomes (1)

  • decreased WOMAC score

    2 weeks

Study Arms (2)

study laser group

EXPERIMENTAL

laser therapy on knee for 2 weeks

Device: LA-400 laser acupuncture

control group

NO INTERVENTION

no intervention

Interventions

low level laser

study laser group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kellgren-Lawrence grade II \~ III

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShinKongHospital

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Ching Wen Huang, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 19, 2020

Study Start

January 1, 2019

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

February 19, 2020

Record last verified: 2019-03

Locations