Low Level Laser Intervention for Individuals With Knee Osteoarthritis

The Effects of Low Level Laser Intervention on Muscular Strength for Individuals With Knee Osteoarthritis

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Low level laser treatment

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Department of Physical Therapy, National Cheng-Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 808nm; 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; 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.
Active Comparator: 660nm; 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; 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.
Placebo Comparator: Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and after treatment, 8 weeks intervention
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)	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	sit-to-stand test, participants are instructed to repeat chair stand movement as fast as they could, investigator records the times they complete. (times)	Baseline and after treatment, 8 weeks intervention
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)	Baseline and after treatment, 8 weeks intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of joint range of motion measured by the goniometer	Joint range of motion of the hip flexion, internal and external rotation, knee flexion, extension on both sides(degrees)	Baseline and after treatment, 8 weeks intervention

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Study Chair: Cheng-Feng Lin, Ph.D, Department of Physical Therapy, National Cheng-Kung University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: A-ER-109-187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No