Back to resultsLow Level Laser Intervention for Individuals With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low level laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- The severity of osteoarthritis was defined by the Kellgren-Lawrence system as grade 2 - grade 3
Exclusion Criteria:
- Uncontrolled hypertension
- Malignant tumor
- Skin cancer
- Pregnant
- Dysesthesia
- Pacemaker inplement
- Cognitive problem
- Fall record within 6 months
- Dysfunction of blood coagulation
Sites / Locations
- Department of Physical Therapy, National Cheng-Kung University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
808nm
660nm
Control
Arm Description
The wavelength of this experimental group was 808nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
The wavelength of this experimental group was 660nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
The wavelength of control group, total power: 0.0072W, 15 minutes a session, 3 times a week for 8 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Changes of walking speed measured by the stop watch
40-m walk test, participants are instructed to walk as fast as they could, investigator records the time they spend. (seconds)
Changes of stair climbing ability measured by the stop watch
stair climbing test, participants are instructed to climb stairs with a total height of 180 cm as fast as they could, investigator records the time they spend. (seconds)
Changes of chair stand ability, the stop watch will be used to measure time and investigators count the time that participants complete
sit-to-stand test, participants are instructed to repeat chair stand movement as fast as they could, investigator records the times they complete. (times)
Changes of dynamic balance ability measured by the stop watch
timed UP&Go test, participants are instructed to stand up from a chair and walk as fast as they could for 3 meters and back to the chair, investigator records the time they spend. (seconds)
Full Information
NCT ID
NCT04828252
First Posted
February 3, 2021
Last Updated
June 21, 2021
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04828252
Brief Title
Low Level Laser Intervention for Individuals With Knee Osteoarthritis
Official Title
The Effects of Low Level Laser Intervention on Muscular Strength for Individuals With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University 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
The purpose of this study was to investigate the intervention effects of low level laser for knee OA group
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
808nm
Arm Type
Experimental
Arm Description
The wavelength of this experimental group was 808nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
Arm Title
660nm
Arm Type
Active Comparator
Arm Description
The wavelength of this experimental group was 660nm, total power: 3.6W, 15 minutes a session, 3 times a week for 8 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The wavelength of control group, total power: 0.0072W, 15 minutes a session, 3 times a week for 8 weeks
Intervention Type
Device
Intervention Name(s)
Low level laser treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of muscular strength of thigh measured by handheld dynamometer
Description
Muscular strength of the knee extensor and flexor on both sides and will be normalized by the body weight of participants' (lb/kg)
Time Frame
Baseline and after treatment, 8 weeks intervention
Secondary Outcome Measure Information:
Title
Changes of walking speed measured by the stop watch
Description
40-m walk test, participants are instructed to walk as fast as they could, investigator records the time they spend. (seconds)
Time Frame
Baseline and after treatment, 8 weeks intervention
Title
Changes of stair climbing ability measured by the stop watch
Description
stair climbing test, participants are instructed to climb stairs with a total height of 180 cm as fast as they could, investigator records the time they spend. (seconds)
Time Frame
Baseline and after treatment, 8 weeks intervention
Title
Changes of chair stand ability, the stop watch will be used to measure time and investigators count the time that participants complete
Description
sit-to-stand test, participants are instructed to repeat chair stand movement as fast as they could, investigator records the times they complete. (times)
Time Frame
Baseline and after treatment, 8 weeks intervention
Title
Changes of dynamic balance ability measured by the stop watch
Description
timed UP&Go test, participants are instructed to stand up from a chair and walk as fast as they could for 3 meters and back to the chair, investigator records the time they spend. (seconds)
Time Frame
Baseline and after treatment, 8 weeks intervention
Other Pre-specified Outcome Measures:
Title
Changes of joint range of motion measured by the goniometer
Description
Joint range of motion of the hip flexion, internal and external rotation, knee flexion, extension on both sides(degrees)
Time Frame
Baseline and after treatment, 8 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The severity of osteoarthritis was defined by the Kellgren-Lawrence system as grade 2 - grade 3
Exclusion Criteria:
Uncontrolled hypertension
Malignant tumor
Skin cancer
Pregnant
Dysesthesia
Pacemaker inplement
Cognitive problem
Fall record within 6 months
Dysfunction of blood coagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Feng Lin, Ph.D
Organizational Affiliation
Department of Physical Therapy, National Cheng-Kung University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Therapy, National Cheng-Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Low Level Laser Intervention for Individuals With Knee Osteoarthritis
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