Effects of High-Intensity Laser Therapy Combined With Exercise in Patients With Knee Osteoarthritis

NCT07630259 | Completed

• 1 other identifier: 422/2023
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to determine whether high-intensity laser therapy (HILT) combined with exercise improves pain, physical function, and muscle strength in people with knee osteoarthritis. The main questions the study aimed to answer were:

• Did HILT combined with exercise lower pain more than sham laser combined with exercise?
• Did HILT combined with exercise improve physical function more than sham laser combined with exercise?
• Did HILT combined with exercise improve knee extensor muscle strength more than sham laser combined with exercise? Researchers compared HILT plus exercise with sham laser plus exercise to determine whether HILT provided additional benefits beyond those achieved with exercise alone. Participants:
• Received either HILT or sham laser treatment for four weeks.
• Participated in a standardized exercise program.
• Completed assessments of pain, physical function, and muscle strength before and after treatment.

Conditions

Osteoarthitis; Osteoarthritis (OA) of the Knee; Osteoarthritis in the Knee; Osteoarthritic Knee Pain; Osteo Arthritis of the Knee; Osteoarthritis (Knee)

Keywords

Knee Osteoarthritis; High Intensity Laser Therapy; HILT; Laser Therapy; Photobiomodulation; Pain; Excercise Therapy; Rehabilitation; Músculo Strength; Physical Function; Musculoskeletal Disorders; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Knee Extensor Muscle Strength After 4 Weeks of Treatment

  Change in knee extensor muscle strength measured with a dynamometer. Results were expressed in Newtons (N). Higher values indicate greater muscle strength.

  Baseline and Week 4

Secondary Outcomes (2)

• Change From Baseline in Pain Intensity After 4 Weeks of Treatment

  Baseline and Week 4

• Change From Baseline in WOMAC Total Score After 4 Weeks of Treatment

  Baseline and Week 4

Study Arms (2)

High Intensity Laser Therapy + Exercise

EXPERIMENTAL

Participants received high-intensity laser therapy (HILT) combined with a standardized exercise program. HILT was delivered using an MLS laser device (MPHI D, ASA Laser, Italy) over four periarticular knee application points during 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises and was identical to that provided to the sham comparator group.

Device: High Intensity Laser Therapy; Other: Exercise

Sham Laser + Exercise

SHAM COMPARATOR

Participants received sham laser treatment combined with the same standardized exercise program used in the experimental group. Sham treatment was delivered using the same laser device and treatment schedule as the active intervention but with subtherapeutic parameters designed to maintain participant blinding. The intervention consisted of 10 treatment sessions over four weeks. The exercise program included strengthening, flexibility, and balance exercises.

Device: Sham Laser; Other: Exercise

Interventions

High Intensity Laser Therapy DEVICE

High-intensity laser therapy (HILT) was delivered using an MLS laser device (MPHI D, ASA Laser, Italy), which combines synchronized 808 nm and 905 nm wavelengths. Treatment was applied to four periarticular knee regions, including the medial and lateral patellar borders, the suprapatellar region, and the medial tibiofemoral joint line. Participants received 10 treatment sessions over four weeks. HILT was administered in combination with a standardized exercise program.

Also known as: HILT, MLS Laser Therapy, Photobiomodulation, Laser Therapy

High Intensity Laser Therapy + Exercise

Sham Laser DEVICE

Sham laser treatment was delivered using the same laser device, treatment schedule, and application sites as the active intervention. Subtherapeutic parameters were used to mimic the treatment procedure while minimizing biological effects and maintaining participant blinding. Participants received 10 treatment sessions over four weeks in combination with the same standardized exercise program used in the experimental group.

Also known as: Sham Laser Therapy, Placebo Laser, Sham High Intensity Laser Therapy

Sham Laser + Exercise

Exercise OTHER

The exercise program was performed during each treatment session and included strengthening, flexibility, and balance exercises targeting the lower extremities. Exercises included stationary cycling, hamstring and gastrocnemius stretching, straight-leg raises, knee extensions, heel raises, step-ups, and single-leg balance activities. The program was standardized for both study groups and was delivered over 10 sessions during a four-week period.

Also known as: Therapeutic exercise, Exercise Program, Physical Therapy exercise, Rehabilitation exercise

High Intensity Laser Therapy + Exercise; Sham Laser + Exercise

Eligibility Criteria

• Age: 45 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of knee osteoarthritis.
• Age between 45 and 77 years.
• Pain intensity of at least 3 points on the Visual Analogue Scale (VAS).

You may not qualify if:

• Presence of other musculoskeletal conditions affecting the lower limbs.
• History of lower limb surgery.
• Tattoos in the laser application area.
• Recent intra-articular corticosteroid injection.
• Comorbidities limiting participation in physical exercise, such as chronic obstructive pulmonary disease, stroke, or severe heart failure.

Sponsors & Collaborators

• Universidad Metropolitana de Ciencias de la Educacion: lead

Study Sites (1)

Departamento de Kinesiología

Santiago, Santiago Metropolitan, 7760197, Chile

Location

Related Publications (4)

• Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.

  PMID: 33807695 BACKGROUND

• Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.

  PMID: 36313402 BACKGROUND

• Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.

  PMID: 33074393 BACKGROUND

• Song HJ, Seo HJ, Kim D. Effectiveness of high-intensity laser therapy in the management of patients with knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. J Back Musculoskelet Rehabil. 2020;33(6):875-884. doi: 10.3233/BMR-191738.

  PMID: 32831189 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Pain; Musculoskeletal Diseases

Interventions

Low-Level Light Therapy; Laser Therapy; Exercise; Exercise Therapy; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Phototherapy; Ablation Techniques; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Ivan Patricio Silva-Satlov, Magister

  Universidad Metropolitana de Ciencias de la Educación

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Principal Investigator

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: November 29, 2023
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
• Access Criteria: Researchers who provide a methodologically sound research proposal may request access to de-identified individual participant data and supporting documents. Requests should be directed to the Principal Investigator. Data will be shared only after review and approval of the proposed use and may require a data sharing agreement to protect participant confidentiality and ensure appropriate use of the data.

Locations

CL (1)