Clinical trial NCT04247893: Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
Official title: Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Physical Therapy Modalities
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional pain
timeFrame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
measure: Stiffness
timeFrame: Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
measure: Physical functional
timeFrame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
Secondary outcomes:
measure: Intensity of pain
timeFrame: Change from Baseline in The Numerical rating pain scale at 12 weeks
measure: Functional capacity for sitting and standing
timeFrame: Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
measure: Level of pressure pain
timeFrame: Change from Baseline in ThePressure Pain Threshold at 12 weeks
measure: Muscle skin temperature
timeFrame: Change from Baseline in the muscle skin temperature at 12 weeks
measure: Maximum voluntary isometric contraction
timeFrame: Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
References: