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Influence of Using Physical Therapy Resources for Knee Osteoarthritis (osteoarthritis)

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ClinicalTrials.gov Identifier: NCT02636764
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Cid André Fidelis de Paula Gomes, University of Nove de Julho

Brief Summary:
Osteoarthritis is a chronic, multifactorial characterization, which changes in bone alignment, cartilage and structures that provide joint stability appear to be strongly correlated with the origin of this disease.This project will aim to verify the effectiveness of interferential current, short wave and low level laser therapy on an exercise program for mobility and pain in knee osteoarthritis. Blind randomized, placebo controlled. Five groups: exercise group, exercise group + Ultrasound therapy, exercise group + interferential current, exercise group + short-wave diathermy, exercise group + Low level laser therapy. Before and after the trial protocol by the following instruments: Western Ontario and McMaster Universities osteoarthritis index (WOMAC), numerical scale of pain assessment (END), Visual Analogue Scale Fatigue (VAS-F), issue F2.2 Instrument assessment of quality of life of the World Health Organization (WHOQOL-100) test sitting and standing + numerical rating pain scale, algometry. This project hypothesizes that the inclusion of photothermal and electrical agents in an exercise program will provide an improvement in pain, mobility and knee function in individuals diagnosed with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Physical Therapy Modalities Other: exercise Device: interferential current Device: short-wave diathermy Device: Low level laser therapy Device: Ultrasound therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Using Physical Therapy Resources for Knee Osteoarthritis
Study Start Date : December 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: exercise group
An exercise protocol drawn up with the objective will be held to strengthen the musculature: flexor and extensor of the knee; extension, abduction, hip side rotator, using the weight and the elastic band.
Other: exercise
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Placebo Comparator: exercise group + Ultrasound therapy
Apart from intervening in the exercise group, an ultrasound device is used .
Other: exercise
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Device: Ultrasound therapy
Ultrasound (US) is a form of mechanical energy, not electrical energy and therefore strictly speaking, not really electrotherapy at all but does fall into the Electro Physical Agents grouping.

Experimental: exercise group + interferential current
Besides the intervention of the exercise group after the exercises will be applied to interferential current through the device. Will be positioned 4 electrodes (8x5 cm), two upper and two lower (forming a square) around the center of the knee.
Other: exercise
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Device: interferential current
The basic principle of Interferential Therapy (IFT) is to utilise the significant physiological effects of low frequency (<250pps) electrical stimulation of nerves without the associated painful and somewhat unpleasant side effects sometimes associated with low frequency stimulation

Experimental: exercise group + short-wave diathermy
Besides the intervention of the exercise group after the exercises will be applied diathermies short wave in continuous mode. For that will be used apparatus, 27.12 megahertz, by means of vulcanized rubber electrodes (12x17 cm) with gentle warming for 30 minutes.
Other: exercise
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Device: short-wave diathermy
Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy

Experimental: exercise group + Low level laser therapy
Apart from intervening in the exercise group, will be applied to Low level laser therapy, through the laser unit, Class 3b, gallium-aluminum-arsenide, continuous mode, wavelength: 830 nanometer, power: 30 watts.
Other: exercise
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Device: Low level laser therapy
Laser treatment in which the energy output is low enough so that the temperature of the treated tissue does not rise above 98.6°F (36.5° C) or normal body temperature.




Primary Outcome Measures :
  1. pain [ Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks ]
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

  2. stiffness [ Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks ]
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

  3. physical functional [ Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks ]
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.


Secondary Outcome Measures :
  1. intensity of pain [ Time Frame: Change from Baseline in The Numerical rating pain scale at 8 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'.

  2. Self-perceived fatigue [ Time Frame: Change from Baseline in the self-perceived fatigue at 8 weeks ]
    a visual analog scale (VAS-F).

  3. Functional capacity for sitting and standing [ Time Frame: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks ]
    sitting-rising test

  4. level of pressure pain [ Time Frame: Change from Baseline in ThePressure Pain Threshold at 8 weeks ]
    Pressure Pain Threshold in the knee with algometer dynamometer.

  5. Self-perceived fatigue [ Time Frame: Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks ]
    The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • knee pain to at least six months and minimum of 4 points in pain scale
  • Diagnosed with osteoarthritis in unilateral knee according to the criteria established by the American College of Rheumatology and confirmed by radiographic examination for identification Kellgren-Lawrence grade 2 or 3 (Kellgren & Lawrence, 1957).

Exclusion Criteria:

  • Any type of physical therapy
  • therapy with intra-articular corticosteroids or therapeutic chondroprotective drugs last year, before the start of the study.
  • history of trauma on his knees, cognitive disorder or psychological disorder,
  • neurological (sensory or motor)
  • cancer
  • diabetes,
  • or any state of adverse acute health osteoarthritis signs of hip
  • cardiopulmonary disease that prevents the conducting exercises
  • require auxiliary device for performing gait.
  • Yet who undertake physical activity in the last two months. Physical activity is defined as strength training and / or more than 20 minutes of aerobic activity twice a week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636764


Locations
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Brazil
University of Nove de Julho
São Paulo, São Paulo, São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Principal Investigator: Cid André Fidelis de Paula Gomes, Phd University of Nove de Julho
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cid André Fidelis de Paula Gomes, Phd, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02636764    
Other Study ID Numbers: 51391715.1.0000.5511
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases