Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis

NCT05975957 | Unknown

• 1 other identifier: ID 369-22-ORTOP-IDOR-RJ-M-I
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is approximately 13% in women and 10% in men. Knee OA (gonarthrosis) has as main risk factors, in addition to age, female gender and obesity. Pharmacological treatment of gonarthrosis is based on approaches to reduce symptoms and/or pain, with joint replacement (arthroplasty) being reserved for more advanced forms of the disease. In general, currently available treatments have only moderate effects and low satisfaction rates among patients. Photobiomodulation Therapy (TFBM) has been used for at least 50 years by health professionals to treat a variety of clinical conditions, especially those associated with chronic pain. TFBM is a treatment using a non-ionizing light source such as Low Intensity Laser (LBI) or Light Emitting Diodes (LED), with near-infrared wavelengths. The aim of this study is to evaluate the intensity of knee pain in the short and medium term after photobiomodulation therapy in patients with gonarthrosis. In this multicenter, randomized, placebo-controlled, double-blind clinical trial, 238 volunteers with gonarthrosis grades II and III according to the Kellgren-Lawrence classification will be recruited to be administered adjuvant treatment with TFBM. The TFBM will be performed in the knee region, twice a week, for five weeks, totaling 10 sessions. Volunteers will be allocated in the intervention group (n=119) or in the placebo group, which will be treated with 10 sessions of inert light (n=119). The hypothesis is that the photobiomodulation therapy will have a positive impact, in the short and medium term, on improving pain, functionality and quality of life of patients with symptomatic gonarthrosis.

Conditions

Osteoarthritis; Gonarthrosis

Keywords

photobiomodulation; gonarthrosis; analgesia

Outcome Measures

Primary Outcomes (1)

• Change of knee pain scale by at least 20% in the FBM group assessed using the Visual Analog Scale (VAS).

  The Visual Analogue Scale (VAS) evaluation is an instrument uses a scale of 0-10 to grade pain intensity, where 0 represents no pain and 10 the worst imaginable pain. The VAS will be applied daily until the 5th week of treatment and weekly from the sixth week to three months after treatment, through an online form sent daily to the patient via cell phone using an integrated application to the RedCap system or similar.

  18 months

Study Arms (2)

FBM

EXPERIMENTAL

volunteers who will receive adjuvant photobiomodulation therapy (n=119)

Device: Photomodulation Therapy with the Light-Aid system

Control

PLACEBO COMPARATOR

volunteers who will receive placebo treatment with inert light (n=119)

Device: Control

Interventions

Photomodulation Therapy with the Light-Aid system DEVICE

Patients in the intervention group (FBM) will be submitted to 10 treatment sessions (twice a week/five weeks) with the Light-Aid system (Bright Photomedicine, SP, Brazil), operated in continuous mode, with 100 LEDs of 850nm wave per tip, with application time varying from 4 to 8 minutes. Irradiation parameters will be customized based on pain intensity, skin phototype and Body Mass Index (BMI).

FBM

Control DEVICE

Patients in the placebo group will undergo the same therapeutic protocol as the FBM group using a device with the same appearance as the Light-Aid System, but with inert light emission. In both groups, the treatment will be administered in contact with the skin over the knee, with the patient positioned in dorsal decubitus. The three tips of the device will be positioned horizontally over the anterior region of the knee with the central tip over the patella.

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes, aged between 50 and 75 years;
• Uni or bilateral symptomatic gonarthrosis grades II or III according to the Kellgren-Lawrence classification confirmed on radiographs with weight bearing in anteroposterior, lateral and axial patella. When the disease is bilateral, the knee indicated by the patient as being the most symptomatic will be included;
• Able to walk independently, with or without walking aids;
• Cognitive ability to answer questionnaires and perform physical tests;
• Agreement to participate in the study by signing the Free and Informed Consent Form (TCLE).

You may not qualify if:

• Diagnosis of active malignancy except basal cell carcinoma (BCC);
• Diseases or neurological conditions that compromise the ability to perform the physical tests;
• Epilepsy;
• Skin lesions on the lower limb, close to the TFBM application site;
• Tattoos on the lower limb, close to the TFBM application site;
• Unicompartmental or total knee arthroplasty in the knee included in the study;
• History of direct trauma to the knee included in the study within the last six months;
• Active systemic inflammatory disease;
• Rheumatological diseases;
• Any previous procedure with an intra-articular approach to the knee in the last six months;
• Anticipation of adopting another form of treatment during the study period, including arthroplasty;
• Patients undergoing knee shock wave treatment in the knee included in the study;
• Absence, inability or refusal to sign the informed consent form.

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead
• TERGOS PESQUISA E ENSINO S.A: collaborator

Study Sites (1)

Hospital Glória D'Or

Rio de Janeiro, 22211-230, Brazil

Location

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MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Agnosia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronica Vianna

  Instituto D'Or de Pesquisa e Ensino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Vianna, Ph.D

CONTACT

+5521995888008; veronica.vianna@rededor.org

Maria EL Duarte, Ph.D

CONTACT

+5521981111294; maria.leite@idor.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter randomized, double-blind, placebo-controlled clinical trial.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: August 31, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)