NCT04828252

Brief Summary

The purpose of this study was to investigate the intervention effects of low level laser for knee OA group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 9, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2021

Completed
Last Updated

June 22, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

February 3, 2021

Last Update Submit

June 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes of muscular strength of thigh measured by handheld dynamometer

    Muscular strength of the knee extensor and flexor on both sides and will be normalized by the body weight of participants' (lb/kg)

    Baseline and after treatment, 8 weeks intervention

Secondary Outcomes (4)

  • Changes of walking speed measured by the stop watch

    Baseline and after treatment, 8 weeks intervention

  • Changes of stair climbing ability measured by the stop watch

    Baseline and after treatment, 8 weeks intervention

  • Changes of chair stand ability, the stop watch will be used to measure time and investigators count the time that participants complete

    Baseline and after treatment, 8 weeks intervention

  • Changes of dynamic balance ability measured by the stop watch

    Baseline and after treatment, 8 weeks intervention

Other Outcomes (1)

  • Changes of joint range of motion measured by the goniometer

    Baseline and after treatment, 8 weeks intervention

Study Arms (3)

808nm

EXPERIMENTAL

The wavelength of this experimental group was 808nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks

Device: Low level laser treatment

660nm

ACTIVE COMPARATOR

The wavelength of this experimental group was 660nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks

Device: Low level laser treatment

Control

PLACEBO COMPARATOR

The wavelength of control group, total power: 0.0072W, 15 minutes a session, 3 times a week for 8 weeks

Device: Low level laser treatment

Interventions

The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.

660nm808nmControl

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The severity of osteoarthritis was defined by the Kellgren-Lawrence system as grade 2 - grade 3

You may not qualify if:

  • Uncontrolled hypertension
  • Malignant tumor
  • Skin cancer
  • Pregnant
  • Dysesthesia
  • Pacemaker inplement
  • Cognitive problem
  • Fall record within 6 months
  • Dysfunction of blood coagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, National Cheng-Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Cheng-Feng Lin, Ph.D

    Department of Physical Therapy, National Cheng-Kung University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

April 2, 2021

Study Start

November 9, 2020

Primary Completion

June 4, 2021

Study Completion

June 4, 2021

Last Updated

June 22, 2021

Record last verified: 2021-02

Locations