Low Level Laser Intervention for Individuals With Knee Osteoarthritis

• ClinicalTrials.gov Identifier: NCT04828252
• Recruitment Status: Completed
• First Posted: April 2, 2021
• Last Update Posted: June 22, 2021
• Sponsor: National Cheng-Kung University Hospital
• Information provided by (Responsible Party): National Cheng-Kung University Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Device: Low level laser treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Low Level Laser Intervention on Muscular Strength for Individuals With Knee Osteoarthritis
• Actual Study Start Date: November 9, 2020
• Actual Primary Completion Date: June 4, 2021
• Actual Study Completion Date: June 4, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Changes of muscular strength of thigh measured by handheld dynamometer [ Time Frame: Baseline and after treatment, 8 weeks intervention ]
   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 :

1. Changes of walking speed measured by the stop watch [ Time Frame: Baseline and after treatment, 8 weeks intervention ]
   40-m walk test, participants are instructed to walk as fast as they could, investigator records the time they spend. (seconds)
2. Changes of stair climbing ability measured by the stop watch [ Time Frame: Baseline and after treatment, 8 weeks intervention ]
   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)
3. Changes of chair stand ability, the stop watch will be used to measure time and investigators count the time that participants complete [ Time Frame: Baseline and after treatment, 8 weeks intervention ]
   sit-to-stand test, participants are instructed to repeat chair stand movement as fast as they could, investigator records the times they complete. (times)
4. Changes of dynamic balance ability measured by the stop watch [ Time Frame: Baseline and after treatment, 8 weeks intervention ]
   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)

Other Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Taiwan

Department of Physical Therapy, National Cheng-Kung University

Tainan, Taiwan, 701

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

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

More Information

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT04828252
• Other Study ID Numbers: A-ER-109-187
• First Posted: April 2, 2021
• Last Update Posted: June 22, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases