Comparison of the Effectiveness of High-Intensity and Low-Intensity Laser Therapies in Primary Knee Osteoarthritis

NCT06825767 | Completed

• 1 other identifier: E1-20-1087
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary goal is to investigate the advantages of low-intensity laser therapy (LLLT) and high-intensity laser therapy (HILT) over conventional therapy in patients with knee osteoarthritis (OA), our secondary goal is to investigate the advantages of HILT and LLLT; to compare its analgesic effects, its effects on functional status and quality of life, and its effects on femoral cartilage thickness.

Conditions

Primary Knee Osteoarthritis

Keywords

Osteoarthritis, Low level light therapy, high level light therapy,Muscle Skeletal; Ultrasonography

Outcome Measures

Primary Outcomes (2)

• range of motion

  In the clinical evaluation, the range of motion of the patients in the affected extremity was determined by goniometry

  Baseline, after 1 month and 3 month changes

• visual pain score (VAS)

  In the clinical evaluation, the pain score with movement and resting was determined by visual pain score (VAS).The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

  Baseline, after 1 month and 3 month changes

Secondary Outcomes (4)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, after 1 month and 3 month changes

• Lequesne Index

  Baseline, after 1 month and 3 month changes

• Short form SF-36 scale

  Baseline, after 1 month and 3 month changes

• Femoral cartilage thickness

  Baseline, after 1 month and 3 month changes

Study Arms (3)

conventional treatment

ACTIVE COMPARATOR

Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients.

Device: Conventional Treatment

conventional treatment and HILT(high-intensity laser therapy)

ACTIVE COMPARATOR

Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients .

Device: conventional treatment and high-intensity laser therapy(HILT)

conventional treatment and LLLT(low-intensity laser therapy)

ACTIVE COMPARATOR

Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients.

Device: conventional treatment and low-intensity laser therapy (LLLT)

Interventions

Conventional Treatment DEVICE

Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients

conventional treatment

conventional treatment and high-intensity laser therapy(HILT) DEVICE

Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients .

conventional treatment and HILT(high-intensity laser therapy)

conventional treatment and low-intensity laser therapy (LLLT) DEVICE

Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients.

conventional treatment and LLLT(low-intensity laser therapy)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range of 55-75 years
• Primary knee OA diagnosis according to ACR (American College of Rheumatology) and Knee OA classified as stage 2-3 according to the KL (Kellgren-Lawrence) radiological classification
• Visual pain score of 4 or higher for knee pain lasting for at least 3 months

You may not qualify if:

• Patients with secondary knee OA
• Patients who have undergone surgical operations related to the knee joint
• Patients with pathology in the hip and/or ankle on the same side
• Patients who have received intra-articular corticosteroid, hyaluronic acid, or PRP injections in the knee joint in the last 6 months
• Patients who have received physical therapy for the knee region in the last 6 months
• Patients with serious systemic diseases such as malignancy, congestive heart failure, or chronic obstructive pulmonary disease
• Patients with insufficient cognitive function

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Phisical Therapy and Rehabilitation Hospital

Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: October 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)