- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636764
Influence of Using Physical Therapy Resources for Knee Osteoarthritis (osteoarthritis)
February 15, 2018 updated by: Cid André Fidelis de Paula Gomes, University of Nove de Julho
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, São Paulo
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São Paulo, São Paulo, São Paulo, Brazil, 01504-001
- University of Nove de Julho
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
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exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
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Placebo Comparator: exercise group + Ultrasound therapy
Apart from intervening in the exercise group, an ultrasound device is used .
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exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
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.
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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.
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exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
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
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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.
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exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
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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.
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exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
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stiffness
Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
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physical functional
Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intensity of pain
Time Frame: Change from Baseline in The Numerical rating pain scale at 8 weeks
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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'.
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Change from Baseline in The Numerical rating pain scale at 8 weeks
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Self-perceived fatigue
Time Frame: Change from Baseline in the self-perceived fatigue at 8 weeks
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a visual analog scale (VAS-F).
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Change from Baseline in the self-perceived fatigue at 8 weeks
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Functional capacity for sitting and standing
Time Frame: Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
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sitting-rising test
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Change from Baseline in The Functional capacity for sitting and standing at 8 weeks
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level of pressure pain
Time Frame: Change from Baseline in ThePressure Pain Threshold at 8 weeks
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Pressure Pain Threshold in the knee with algometer dynamometer.
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Change from Baseline in ThePressure Pain Threshold at 8 weeks
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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
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The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).
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Change from Baseline in The question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100) at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cid André Fidelis de Paula Gomes, Phd, University of Nove de Julho
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
December 17, 2015
First Posted (Estimate)
December 22, 2015
Study Record Updates
Last Update Posted (Actual)
February 19, 2018
Last Update Submitted That Met QC Criteria
February 15, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 51391715.1.0000.5511
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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