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

NCT06632119 | Completed Phase 2

• 1 other identifier: MU_CIRB 2024/003.0401
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

HILT; Laser therapy; joint sense; muscle strength; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Knee muscle strength

  Baseline, immediately after, 24-hour after intervention

• Pain

  Baseline, immediately after, 24-hour after intervention

Study Arms (2)

HILT

ACTIVE COMPARATOR

high-intensity laser therapy (HILT)

Device: high-intensity laser therapy

Sham_HILT

PLACEBO COMPARATOR

Sham-HILT, the HILT without laser release

Device: Sham-HILT

Interventions

high-intensity laser therapy DEVICE

high-intensity laser therapy (HILT) machine, ASA laser

HILT

Sham-HILT DEVICE

Sham-HILT, HILT machine without laser release

Sham_HILT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Physical Therapy

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prasert Sakulsriprasert, Ph.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: January 5, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)