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Completed

NCT Number: NCT02636764

Influence of Using Physical Therapy Resources for Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Physical Therapy Modalities Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho

São Paulo, São Paulo, São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.

Interferential Current

Device

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

Short-Wave Diathermy

Device

Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy

Low Level Laser Therapy

Device

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.

Ultrasound therapy

Device

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Acronym: osteoarthritis

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 22, 2015
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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