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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04247893
• Other study ID #: 20123719.1.0000.5511
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2020
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Physical Therapy Modalities

Intervention

Device:
• blood flow restriction
Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
• Photobiomodulation
Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
• Placebo photobiomodulation
Placebo photobiomodulation - photobiomodulation device turned off.

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional pain	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Primary	Stiffness	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.	Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Primary	Physical functional	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.	Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Secondary	Intensity of pain	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'.	Change from Baseline in The Numerical rating pain scale at 12 weeks
Secondary	Functional capacity for sitting and standing	sitting-rising test	Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
Secondary	Level of pressure pain	Pressure Pain Threshold in the knee with algometer dynamometer.	Change from Baseline in ThePressure Pain Threshold at 12 weeks
Secondary	Muscle skin temperature	Infrared thermography, thermal imaging. Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.	Change from Baseline in the muscle skin temperature at 12 weeks
Secondary	Maximum voluntary isometric contraction	A portable dynamometer will be used to assess muscle contraction.	Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks