Immediate Effects of High-intensity Laser Therapy on Knee Joint Position Sense and Knee Muscle Strength in Patients with Knee Osteoarthritis (HILT on KOA)

The goal of this clinical trial is to compare whether HILT versus Sham-HILT is effective to reduce pain, improve knee joint position sense, and knee muscle strength.

Participants will undergo a single-session of HILT or Sham-HILT, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: high-intensity laser therapy; Device: Sham-HILT

Detailed Description

The investigators would like to investigate whether single session of high-intensity laser therapy (HILT) is promising to see the changes in individuals with knee osteoarthritis (KOA)-related knee pain regarding pain intensity, knee joint position sense, and knee muscle strength.

The objectives of this study is to compare pre and post, and between the two groups (HILT versus Sham-HILT) at after interventions regarding pain, knee joint position sense, and knee muscle strength.

Participants will undergo a single-session of HILT or Sham-HILT by an experienced musculoskeletal physical therapist, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom
    • Salaya, Nakhon Pathom, Thailand, 73170
      • Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• knee pain greater than 3 on the Visual Analog Scale (VAS) for more than 3 months
• diagnosed with unilateral knee osteoarthritis by a physician or meeting the American College of Rheumatology Classification Criteria for clinical knee osteoarthritis
• the severity of knee osteoarthritis is classified as grades 0-3 according to the Kellgren-Lawrence (KL) classification
• should not have undergone any specific treatments in the 3 months preceding the recruitment for the study, such as steroid injections.

Exclusion Criteria:

• any other musculoskeletal problems associated with knee pain
• musculoskeletal problems associated with the hip and ankle joints
• a history of lower limb fracture
• neurological conditions
• contraindications for laser therapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HILT; high-intensity laser therapy (HILT)	Device: high-intensity laser therapy; high-intensity laser therapy (HILT) machine, ASA laser
Placebo Comparator: Sham_HILT; Sham-HILT, the HILT without laser release	Device: Sham-HILT; Sham-HILT, HILT machine without laser release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee joint position sense	Knee joint position sense, the investigators used the joint position repositioning technique. The participants were measured for joint position reposition technique with a smartphone application "Measure App" (iPhone 12 Pro Max, Apple Inc., USA). The smartphone attached at shank of tibia bone at the malleolar level. The participants sat in the starting position knee flexion 90°. Then the participants with eyes closed were actively guided to the knee flexion 45 degrees and hold for 3 seconds. The data was recorded the difference between performed position and targeted position.	Baseline, immediately after, 24-hour after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee muscle strength	The muscle strength measured both quadriceps and hamstring muscles by the handheld dynamometer at 90°.	Baseline, immediately after, 24-hour after intervention
Pain	The participants rated the pain scores using a 10-cm visual analog scale (VAS) ranged from 0 "no pain at all" on the left end to 10 "worst pain imaginable" on the right end.	Baseline, immediately after, 24-hour after intervention

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Prasert Sakulsriprasert, Ph.D., Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pain; muscle strength; Laser therapy; HILT; joint sense
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MU_CIRB 2024/003.0401 (Mahidol University Central Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No