RecruitingPhase 2Phase 3NCT05816798

Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery

Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial


Sponsor

University of Nove de Julho

Enrollment

62 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Chronic pain is a global public health problem, which intensifies even more in the obese population, reaching about 33% of these patients. Among the topography, chronic knee pain affects 80%, constituting an important cause of disability and decreased quality of life. In addition, in grade 3 obesity, also called morbid obesity, in which bariatric surgery is already indicated, knee pain makes it difficult or prevents participation in the pre-habilitation program that includes physical therapy through therapeutic exercises with the aim of reducing postoperative complications. In this sense, a double-blind, randomized, placebo-controlled clinical trial will be conducted with the objective of evaluating the effect of photobiomodulation (PBM) on pain and functionality of obese patients with chronic knee pain who are in a prehabilitation program for bariatric surgery, discussing its role as an analgesic therapy and modifier of peripheral and central sensitization mechanisms of the pain pathway. PBM is a safe treatment option, with no undesirable effects and low cost. The primary outcomes will be pain intensity, through visual analogue scale, and Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, validated version for Portuguese - Brazil. Secondary outcomes will be pressure pain threshold and rolling pinch maneuver measured by digital algometer. Other exploratory outcomes will be 6-minute walk test, knee range of motion, SF-36 quality of life questionnaire. There will be 2 groups: an intervention group (photobiomodulation associated with standard physiotherapy treatment) and another placebo group (device turned off associated with the same standard physiotherapy treatment). The application sites will be knees and lumbar paravertebral 2 times a week for 12 weeks. The dosimetric standards will be 4J/point in the knees and 3J/point in the lumbar. The results obtained will be statistically analyzed and later published in a scientific journal.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Photobiomodulation, a medical device called Photobiomodulation Placebo, and others for people with chronic knee pain and obesity, morbid. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhotobiomodulation

PBM is a therapeutic technique that uses light at different wavelengths (red or infrared), in a non-invasive way in which non-ionizing irradiation is used to produce a series of photophysical and photochemical effects when applied to biological tissues (humans and animals). Regarding the clinical results, numerous articles have already demonstrated the effect of PBM in improving pain and disability in patients with knee joint pain.

OTHERStandard Physiotherapy Tretament

standard treatment (physiotherapy-standard exercises: Cardiopulmonary physiotherapy and Physiotherapy with global muscle strengthening exercises). This program will be maintained for all study patients, for both groups, throughout the data collection period and includes activities 2X per week.)

DEVICEPhotobiomodulation Placebo

The same interventions described of Photobiomodulation Group bu device will be turned off


Locations(1)

Gastric Outpatient Clinic of HC-UFG

Goiânia, Goiás, Brazil

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NCT05816798


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