Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis, Knee; Physical Therapy Modalities
• Interventions: Device: blood flow restriction; Device: Photobiomodulation; Device: Placebo photobiomodulation

• Registration Number: NCT04247893
• Lead Sponsor: University of Nove de Julho

Brief Summary

Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus. For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. A significance level of 5% will be adopted.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-31
• Study Start: 2020-11
• Primary Completion: 2020-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• knee pain to at least six months and minimum of 4 points in pain scale
• diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.

Exclusion Criteria

• Score on the numerical visual analog of knee pain less than 1 or greater than 8;
• knee trauma;
• Cognitive impairment;
• Psychological disorder;
• Neurological disorder (sensory or motor);
• Cancer;
• Diabetes any acute adverse health condition;
• Signs of hip OA;
• Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
• Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
• If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood flow restriction exercises + placebo photobiomodulation	blood flow restriction	Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted. Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs.
Exercises with blood flow restriction + photobiomodulation	blood flow restriction	Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs.
Exercises with blood flow restriction + photobiomodulation	Photobiomodulation	Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs.
Blood flow restriction exercises + placebo photobiomodulation	Placebo photobiomodulation	Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted. Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs.
Exercises with blood flow restriction	blood flow restriction	Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.

Primary Outcome Measures

Name	Time	Method
Functional pain	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Stiffness	Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Physical functional	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

Secondary Outcome Measures

Name	Time	Method
Intensity of pain	Change from Baseline in The Numerical rating pain scale at 12 weeks	The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
Functional capacity for sitting and standing	Change from Baseline in The Functional capacity for sitting and standing at 12 weeks	sitting-rising test
Level of pressure pain	Change from Baseline in ThePressure Pain Threshold at 12 weeks	Pressure Pain Threshold in the knee with algometer dynamometer.
Muscle skin temperature	Change from Baseline in the muscle skin temperature at 12 weeks	Infrared thermography, thermal imaging. Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
Maximum voluntary isometric contraction	Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks	A portable dynamometer will be used to assess muscle contraction.

Trial Locations

Locations (1)

University of Nove de Julho; 🇧🇷 São Paulo, Brazil