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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04247893
Enrollment
60
Registered
2020-01-30
Start date
2020-11-30
Completion date
2022-12-31
Last updated
2020-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee, Physical Therapy Modalities

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.

Interventions

DEVICEblood 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.

DEVICEPhotobiomodulation

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 - photobiomodulation device turned off.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional painChange from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeksThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
StiffnessTime Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeksThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Physical functionalChange from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeksThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

Secondary

MeasureTime frameDescription
Muscle skin temperatureChange from Baseline in the muscle skin temperature at 12 weeksInfrared thermography, thermal imaging. Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
Intensity of painChange from Baseline in The Numerical rating pain scale at 12 weeksThe 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'.
Maximum voluntary isometric contractionChange from Baseline in the Maximum voluntary isometric contraction at 12 weeksA portable dynamometer will be used to assess muscle contraction.
Functional capacity for sitting and standingChange from Baseline in The Functional capacity for sitting and standing at 12 weekssitting-rising test
Level of pressure painChange from Baseline in ThePressure Pain Threshold at 12 weeksPressure Pain Threshold in the knee with algometer dynamometer.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026