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

NCT04247893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-31

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Physical Therapy Modalities

Interventions

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.

DEVICE

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.

DEVICE

Placebo photobiomodulation

Placebo photobiomodulation - photobiomodulation device turned off.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2020-11-30
Completion
2022-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247893 on ClinicalTrials.gov