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

Primary Purpose

Osteoarthritis, Physical Therapy Modalities

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
exercise
interferential current
short-wave diathermy
Low level laser therapy
Ultrasound therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

exercise group

exercise group + Ultrasound therapy

exercise group + interferential current

exercise group + short-wave diathermy

exercise group + Low level laser therapy

Arm Description

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.

Apart from intervening in the exercise group, an ultrasound device is used .

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.

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.

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.

Outcomes

Primary Outcome Measures

pain
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
stiffness
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
physical functional
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.

Secondary Outcome Measures

intensity of pain
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'.
Self-perceived fatigue
a visual analog scale (VAS-F).
Functional capacity for sitting and standing
sitting-rising test
level of pressure pain
Pressure Pain Threshold in the knee with algometer dynamometer.
Self-perceived fatigue
The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).

Full Information

First Posted
December 10, 2015
Last Updated
February 15, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02636764
Brief Title
Influence of Using Physical Therapy Resources for Knee Osteoarthritis
Acronym
osteoarthritis
Official Title
Influence of Using Physical Therapy Resources for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
exercise group + Ultrasound therapy
Arm Type
Placebo Comparator
Arm Description
Apart from intervening in the exercise group, an ultrasound device is used .
Arm Title
exercise group + interferential current
Arm Type
Experimental
Arm Description
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.
Arm Title
exercise group + short-wave diathermy
Arm Type
Experimental
Arm Description
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.
Arm Title
exercise group + Low level laser therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
Intervention Type
Device
Intervention Name(s)
interferential current
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
short-wave diathermy
Intervention Description
Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
Intervention Type
Device
Intervention Name(s)
Low level laser therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound therapy
Intervention Description
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 Outcome Measure Information:
Title
pain
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Time Frame
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Title
stiffness
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Time Frame
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Title
physical functional
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
Time Frame
Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
Secondary Outcome Measure Information:
Title
intensity of pain
Description
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'.
Time Frame
Change from Baseline in The Numerical rating pain scale at 8 weeks
Title
Self-perceived fatigue
Description
a visual analog scale (VAS-F).
Time Frame
Change from Baseline in the self-perceived fatigue at 8 weeks
Title
Functional capacity for sitting and standing
Description
sitting-rising test
Time Frame
Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
Title
level of pressure pain
Description
Pressure Pain Threshold in the knee with algometer dynamometer.
Time Frame
Change from Baseline in ThePressure Pain Threshold at 8 weeks
Title
Self-perceived fatigue
Description
The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cid André Fidelis de Paula Gomes, Phd
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
São Paulo
State/Province
São Paulo, São Paulo
ZIP/Postal Code
01504-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32312265
Citation
de Paula Gomes CAF, Politti F, de Souza Bacelar Pereira C, da Silva ACB, Dibai-Filho AV, de Oliveira AR, Biasotto-Gonzalez DA. Exercise program combined with electrophysical modalities in subjects with knee osteoarthritis: a randomised, placebo-controlled clinical trial. BMC Musculoskelet Disord. 2020 Apr 20;21(1):258. doi: 10.1186/s12891-020-03293-3.
Results Reference
derived
Links:
URL
http://www.uninove.br
Description
Related Info

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Influence of Using Physical Therapy Resources for Knee Osteoarthritis

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